Trial Outcomes & Findings for Iron Reduction for the Treatment of Diabetes and Nonalcoholic Fatty Liver Disease (NCT NCT03696797)
NCT ID: NCT03696797
Last Updated: 2026-06-09
Results Overview
HgbA1c measures average blood glucose levels over the past 2-3 months. HgbA1C values from baseline and month 6 will be reported.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
132 participants
Primary outcome timeframe
month 6
Results posted on
2026-06-09
Participant Flow
Participant milestones
| Measure |
Treatment Group
Will have a Unit of blood (two cups, the same amount donated at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure your blood count to be sure you are not anemic, and blood pressure to be sure no dehydration. During or after donation, a sports drink is provided to replace the fluid loss. Phlebotomy
Blood Donation: Participants in the TREATMENT GROUP will have a Unit of blood (two cups, the same amount you would donate at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure blood count to be sure participants are not anemic, and blood pressure to be sure there is no dehydration. During or after donation, participants will be given a sports drink to replace the fluid loss. Participants in the CONTROL GROUP will not donate blood, but will have a needle inserted into a vein in your arm. Neither group will not know to which they have been assigned, all will have a sleep mask (like a blindfold, covering the eyes, held on with an elastic band) placed so they will not know whether blood was actually removed.
|
Control Group
Will not donate blood, but will have a needle inserted into a vein in your arm. Both groups will not know which group assignment they have been randomized. Sham Phlebotomy
Sham Blood Donation: Participants will have a needle inserted their arm, however, no blood will be drawn.
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
68
|
|
Overall Study
COMPLETED
|
19
|
26
|
|
Overall Study
NOT COMPLETED
|
45
|
42
|
Reasons for withdrawal
| Measure |
Treatment Group
Will have a Unit of blood (two cups, the same amount donated at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure your blood count to be sure you are not anemic, and blood pressure to be sure no dehydration. During or after donation, a sports drink is provided to replace the fluid loss. Phlebotomy
Blood Donation: Participants in the TREATMENT GROUP will have a Unit of blood (two cups, the same amount you would donate at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure blood count to be sure participants are not anemic, and blood pressure to be sure there is no dehydration. During or after donation, participants will be given a sports drink to replace the fluid loss. Participants in the CONTROL GROUP will not donate blood, but will have a needle inserted into a vein in your arm. Neither group will not know to which they have been assigned, all will have a sleep mask (like a blindfold, covering the eyes, held on with an elastic band) placed so they will not know whether blood was actually removed.
|
Control Group
Will not donate blood, but will have a needle inserted into a vein in your arm. Both groups will not know which group assignment they have been randomized. Sham Phlebotomy
Sham Blood Donation: Participants will have a needle inserted their arm, however, no blood will be drawn.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
18
|
18
|
|
Overall Study
lost to follow up
|
17
|
17
|
|
Overall Study
Adverse Event
|
10
|
7
|
Baseline Characteristics
Iron Reduction for the Treatment of Diabetes and Nonalcoholic Fatty Liver Disease
Baseline characteristics by cohort
| Measure |
Treatment Group
n=64 Participants
Will have a Unit of blood (two cups, the same amount donated at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure your blood count to be sure you are not anemic, and blood pressure to be sure no dehydration. During or after donation, a sports drink is provided to replace the fluid loss. Phlebotomy
Blood Donation: Participants in the TREATMENT GROUP will have a Unit of blood (two cups, the same amount you would donate at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure blood count to be sure participants are not anemic, and blood pressure to be sure there is no dehydration. During or after donation, participants will be given a sports drink to replace the fluid loss. Participants in the CONTROL GROUP will not donate blood, but will have a needle inserted into a vein in your arm. Neither group will not know to which they have been assigned, all will have a sleep mask (like a blindfold, covering the eyes, held on with an elastic band) placed so they will not know whether blood was actually removed.
|
Control Group
n=68 Participants
Will not donate blood, but will have a needle inserted into a vein in your arm. Both groups will not know which group assignment they have been randomized. Sham Phlebotomy
Sham Blood Donation: Participants will have a needle inserted their arm, however, no blood will be drawn.
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 8.2 • n=20 Participants
|
60 years
STANDARD_DEVIATION 8.4 • n=20 Participants
|
60.4 years
STANDARD_DEVIATION 8.1 • n=40 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=20 Participants
|
35 Participants
n=20 Participants
|
73 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=20 Participants
|
33 Participants
n=20 Participants
|
59 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=20 Participants
|
65 Participants
n=20 Participants
|
125 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
31 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=20 Participants
|
44 Participants
n=20 Participants
|
88 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=20 Participants
|
68 participants
n=20 Participants
|
132 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: BaselineHgbA1c measures average blood glucose levels over the past 2-3 months. HgbA1C values from baseline and month 6 will be reported.
Outcome measures
| Measure |
Treatment Group
n=64 Participants
Will have a Unit of blood (two cups, the same amount donated at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure your blood count to be sure you are not anemic, and blood pressure to be sure no dehydration. During or after donation, a sports drink is provided to replace the fluid loss. Phlebotomy
Blood Donation: Participants in the TREATMENT GROUP will have a Unit of blood (two cups, the same amount you would donate at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure blood count to be sure participants are not anemic, and blood pressure to be sure there is no dehydration. During or after donation, participants will be given a sports drink to replace the fluid loss. Participants in the CONTROL GROUP will not donate blood, but will have a needle inserted into a vein in your arm. Neither group will not know to which they have been assigned, all will have a sleep mask (like a blindfold, covering the eyes, held on with an elastic band) placed so they will not know whether blood was actually removed.
|
Control Group
n=68 Participants
Will not donate blood, but will have a needle inserted into a vein in your arm. Both groups will not know which group assignment they have been randomized. Sham Phlebotomy
Sham Blood Donation: Participants will have a needle inserted their arm, however, no blood will be drawn.
|
|---|---|---|
|
HgbA1c Value
|
6.31 percentage of HgbA1c
Standard Deviation 0.75
|
6.22 percentage of HgbA1c
Standard Deviation 0.57
|
PRIMARY outcome
Timeframe: month 6HgbA1c measures average blood glucose levels over the past 2-3 months. HgbA1C values from baseline and month 6 will be reported.
Outcome measures
| Measure |
Treatment Group
n=19 Participants
Will have a Unit of blood (two cups, the same amount donated at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure your blood count to be sure you are not anemic, and blood pressure to be sure no dehydration. During or after donation, a sports drink is provided to replace the fluid loss. Phlebotomy
Blood Donation: Participants in the TREATMENT GROUP will have a Unit of blood (two cups, the same amount you would donate at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure blood count to be sure participants are not anemic, and blood pressure to be sure there is no dehydration. During or after donation, participants will be given a sports drink to replace the fluid loss. Participants in the CONTROL GROUP will not donate blood, but will have a needle inserted into a vein in your arm. Neither group will not know to which they have been assigned, all will have a sleep mask (like a blindfold, covering the eyes, held on with an elastic band) placed so they will not know whether blood was actually removed.
|
Control Group
n=26 Participants
Will not donate blood, but will have a needle inserted into a vein in your arm. Both groups will not know which group assignment they have been randomized. Sham Phlebotomy
Sham Blood Donation: Participants will have a needle inserted their arm, however, no blood will be drawn.
|
|---|---|---|
|
HgbA1c Value
|
6.43 percentage of HgbA1c
Standard Deviation 0.77
|
6.32 percentage of HgbA1c
Standard Deviation 0.56
|
PRIMARY outcome
Timeframe: BaselineAn ALT test measures a liver enzyme. ALT values from baseline and month 12 will be reported.
Outcome measures
| Measure |
Treatment Group
n=64 Participants
Will have a Unit of blood (two cups, the same amount donated at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure your blood count to be sure you are not anemic, and blood pressure to be sure no dehydration. During or after donation, a sports drink is provided to replace the fluid loss. Phlebotomy
Blood Donation: Participants in the TREATMENT GROUP will have a Unit of blood (two cups, the same amount you would donate at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure blood count to be sure participants are not anemic, and blood pressure to be sure there is no dehydration. During or after donation, participants will be given a sports drink to replace the fluid loss. Participants in the CONTROL GROUP will not donate blood, but will have a needle inserted into a vein in your arm. Neither group will not know to which they have been assigned, all will have a sleep mask (like a blindfold, covering the eyes, held on with an elastic band) placed so they will not know whether blood was actually removed.
|
Control Group
n=68 Participants
Will not donate blood, but will have a needle inserted into a vein in your arm. Both groups will not know which group assignment they have been randomized. Sham Phlebotomy
Sham Blood Donation: Participants will have a needle inserted their arm, however, no blood will be drawn.
|
|---|---|---|
|
ALT (Alanine Aminotransferase) Value
|
25.5 IU/L
Standard Deviation 15.7
|
24.1 IU/L
Standard Deviation 12.0
|
PRIMARY outcome
Timeframe: month 12An ALT test measures a liver enzyme. ALT values from baseline and month 12 will be reported.
Outcome measures
| Measure |
Treatment Group
n=19 Participants
Will have a Unit of blood (two cups, the same amount donated at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure your blood count to be sure you are not anemic, and blood pressure to be sure no dehydration. During or after donation, a sports drink is provided to replace the fluid loss. Phlebotomy
Blood Donation: Participants in the TREATMENT GROUP will have a Unit of blood (two cups, the same amount you would donate at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure blood count to be sure participants are not anemic, and blood pressure to be sure there is no dehydration. During or after donation, participants will be given a sports drink to replace the fluid loss. Participants in the CONTROL GROUP will not donate blood, but will have a needle inserted into a vein in your arm. Neither group will not know to which they have been assigned, all will have a sleep mask (like a blindfold, covering the eyes, held on with an elastic band) placed so they will not know whether blood was actually removed.
|
Control Group
n=26 Participants
Will not donate blood, but will have a needle inserted into a vein in your arm. Both groups will not know which group assignment they have been randomized. Sham Phlebotomy
Sham Blood Donation: Participants will have a needle inserted their arm, however, no blood will be drawn.
|
|---|---|---|
|
ALT Value
|
23.0 IU/L
Standard Deviation 12.5
|
27.7 IU/L
Standard Deviation 14.3
|
PRIMARY outcome
Timeframe: BaselinePopulation: Only a few participants were able to donate for this outcome because the lab closed due to COVID--it was not collected at the same visit as all other baseline labs.
Studies often report DI values with a wide range. Normal or reference ranges can vary substantially depending on the study. Higher values indicate better -cell function. The Disposition Index (DI) derived from the Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT) is a measure of pancreatic -cell function, calculated as the product of insulin sensitivity (S1) and the acute insulin response to glucose (AIRg). It acts as a marker for how well insulin secretion compensates for insulin.
Outcome measures
| Measure |
Treatment Group
n=3 Participants
Will have a Unit of blood (two cups, the same amount donated at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure your blood count to be sure you are not anemic, and blood pressure to be sure no dehydration. During or after donation, a sports drink is provided to replace the fluid loss. Phlebotomy
Blood Donation: Participants in the TREATMENT GROUP will have a Unit of blood (two cups, the same amount you would donate at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure blood count to be sure participants are not anemic, and blood pressure to be sure there is no dehydration. During or after donation, participants will be given a sports drink to replace the fluid loss. Participants in the CONTROL GROUP will not donate blood, but will have a needle inserted into a vein in your arm. Neither group will not know to which they have been assigned, all will have a sleep mask (like a blindfold, covering the eyes, held on with an elastic band) placed so they will not know whether blood was actually removed.
|
Control Group
n=3 Participants
Will not donate blood, but will have a needle inserted into a vein in your arm. Both groups will not know which group assignment they have been randomized. Sham Phlebotomy
Sham Blood Donation: Participants will have a needle inserted their arm, however, no blood will be drawn.
|
|---|---|---|
|
FSIGTT DI (Frequently Sampled Intravenous Glucose Tolerance Test) Value
|
39.6 Si*AIRg
Standard Deviation 9.9
|
40.8 Si*AIRg
Standard Deviation 8.0
|
PRIMARY outcome
Timeframe: month 6Population: Only a few participants were able to donate for this outcome because the lab closed due to COVID--it was not collected at the same visit as all other month 6 labs.
Studies often report DI values with a wide range. Normal or reference ranges can vary substantially depending on the study. Higher values indicate better -cell function. The Disposition Index (DI) derived from the Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT) is a measure of pancreatic -cell function, calculated as the product of insulin sensitivity (S1) and the acute insulin response to glucose (AIRg). It acts as a marker for how well insulin secretion compensates for insulin.
Outcome measures
| Measure |
Treatment Group
n=3 Participants
Will have a Unit of blood (two cups, the same amount donated at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure your blood count to be sure you are not anemic, and blood pressure to be sure no dehydration. During or after donation, a sports drink is provided to replace the fluid loss. Phlebotomy
Blood Donation: Participants in the TREATMENT GROUP will have a Unit of blood (two cups, the same amount you would donate at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure blood count to be sure participants are not anemic, and blood pressure to be sure there is no dehydration. During or after donation, participants will be given a sports drink to replace the fluid loss. Participants in the CONTROL GROUP will not donate blood, but will have a needle inserted into a vein in your arm. Neither group will not know to which they have been assigned, all will have a sleep mask (like a blindfold, covering the eyes, held on with an elastic band) placed so they will not know whether blood was actually removed.
|
Control Group
n=3 Participants
Will not donate blood, but will have a needle inserted into a vein in your arm. Both groups will not know which group assignment they have been randomized. Sham Phlebotomy
Sham Blood Donation: Participants will have a needle inserted their arm, however, no blood will be drawn.
|
|---|---|---|
|
FSIGTT DI Value
|
39.8 Si*AIRg
Standard Deviation 4.4
|
42.5 Si*AIRg
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: Month 12HgbA1c measures average blood glucose levels over the past 2-3 months.
Outcome measures
| Measure |
Treatment Group
n=19 Participants
Will have a Unit of blood (two cups, the same amount donated at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure your blood count to be sure you are not anemic, and blood pressure to be sure no dehydration. During or after donation, a sports drink is provided to replace the fluid loss. Phlebotomy
Blood Donation: Participants in the TREATMENT GROUP will have a Unit of blood (two cups, the same amount you would donate at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure blood count to be sure participants are not anemic, and blood pressure to be sure there is no dehydration. During or after donation, participants will be given a sports drink to replace the fluid loss. Participants in the CONTROL GROUP will not donate blood, but will have a needle inserted into a vein in your arm. Neither group will not know to which they have been assigned, all will have a sleep mask (like a blindfold, covering the eyes, held on with an elastic band) placed so they will not know whether blood was actually removed.
|
Control Group
n=26 Participants
Will not donate blood, but will have a needle inserted into a vein in your arm. Both groups will not know which group assignment they have been randomized. Sham Phlebotomy
Sham Blood Donation: Participants will have a needle inserted their arm, however, no blood will be drawn.
|
|---|---|---|
|
HgbA1c Value at Month 12
|
6.56 % of HgbA1c
Standard Deviation 0.72
|
6.35 % of HgbA1c
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Month 6, Month 12Fasting glucose measured on glucose machine (Abbott Freestyle Libre Pro system). Difference in values from baseline through month 6 and baseline through month 12 will be reported.
Outcome measures
| Measure |
Treatment Group
n=19 Participants
Will have a Unit of blood (two cups, the same amount donated at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure your blood count to be sure you are not anemic, and blood pressure to be sure no dehydration. During or after donation, a sports drink is provided to replace the fluid loss. Phlebotomy
Blood Donation: Participants in the TREATMENT GROUP will have a Unit of blood (two cups, the same amount you would donate at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure blood count to be sure participants are not anemic, and blood pressure to be sure there is no dehydration. During or after donation, participants will be given a sports drink to replace the fluid loss. Participants in the CONTROL GROUP will not donate blood, but will have a needle inserted into a vein in your arm. Neither group will not know to which they have been assigned, all will have a sleep mask (like a blindfold, covering the eyes, held on with an elastic band) placed so they will not know whether blood was actually removed.
|
Control Group
n=26 Participants
Will not donate blood, but will have a needle inserted into a vein in your arm. Both groups will not know which group assignment they have been randomized. Sham Phlebotomy
Sham Blood Donation: Participants will have a needle inserted their arm, however, no blood will be drawn.
|
|---|---|---|
|
Change in Fasting Glucose
baseline through month 6
|
-4 mg/dL
Standard Deviation 21
|
3.2 mg/dL
Standard Deviation 12
|
|
Change in Fasting Glucose
baseline through month 12
|
-4 mg/dL
Standard Deviation 24
|
4.5 mg/dL
Standard Deviation 14
|
SECONDARY outcome
Timeframe: baseline, month 12Population: Not collected in all participants
Insulin sensitivity measured by HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) calculated from fasting glucose and insulin. Values will be reported for Baseline and 12 months. HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) is a calculated score that uses fasting insulin and glucose to measure insulin resistance. An optimal score is generally below 1.0, while values above 1.9 suggest early insulin resistance, and those above 2.9 indicate significant insulin resistance. HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) measures insulin resistance by multiplying fasting insulin and fasting glucose, then dividing by 405. A score below 1.0 indicates optimal insulin sensitivity, while above 1.9-2.0 suggests early resistance, and above 2.9 indicates significant resistance.
Outcome measures
| Measure |
Treatment Group
n=18 Participants
Will have a Unit of blood (two cups, the same amount donated at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure your blood count to be sure you are not anemic, and blood pressure to be sure no dehydration. During or after donation, a sports drink is provided to replace the fluid loss. Phlebotomy
Blood Donation: Participants in the TREATMENT GROUP will have a Unit of blood (two cups, the same amount you would donate at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure blood count to be sure participants are not anemic, and blood pressure to be sure there is no dehydration. During or after donation, participants will be given a sports drink to replace the fluid loss. Participants in the CONTROL GROUP will not donate blood, but will have a needle inserted into a vein in your arm. Neither group will not know to which they have been assigned, all will have a sleep mask (like a blindfold, covering the eyes, held on with an elastic band) placed so they will not know whether blood was actually removed.
|
Control Group
n=22 Participants
Will not donate blood, but will have a needle inserted into a vein in your arm. Both groups will not know which group assignment they have been randomized. Sham Phlebotomy
Sham Blood Donation: Participants will have a needle inserted their arm, however, no blood will be drawn.
|
|---|---|---|
|
HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) Score
baseline
|
7.97 score on a scale
Standard Deviation 13.7
|
5.28 score on a scale
Standard Deviation 5.63
|
|
HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) Score
month 12
|
5.28 score on a scale
Standard Deviation 5.9
|
6.82 score on a scale
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: Month 12The numbers of participants that discontinued of oral antihyperglycemic agents
Outcome measures
| Measure |
Treatment Group
n=19 Participants
Will have a Unit of blood (two cups, the same amount donated at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure your blood count to be sure you are not anemic, and blood pressure to be sure no dehydration. During or after donation, a sports drink is provided to replace the fluid loss. Phlebotomy
Blood Donation: Participants in the TREATMENT GROUP will have a Unit of blood (two cups, the same amount you would donate at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure blood count to be sure participants are not anemic, and blood pressure to be sure there is no dehydration. During or after donation, participants will be given a sports drink to replace the fluid loss. Participants in the CONTROL GROUP will not donate blood, but will have a needle inserted into a vein in your arm. Neither group will not know to which they have been assigned, all will have a sleep mask (like a blindfold, covering the eyes, held on with an elastic band) placed so they will not know whether blood was actually removed.
|
Control Group
n=26 Participants
Will not donate blood, but will have a needle inserted into a vein in your arm. Both groups will not know which group assignment they have been randomized. Sham Phlebotomy
Sham Blood Donation: Participants will have a needle inserted their arm, however, no blood will be drawn.
|
|---|---|---|
|
Number of Participants That Discontinued of Oral Antihyperglycemic Agent
|
6 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 12The change in weight from baseline to month 12 will be reported
Outcome measures
| Measure |
Treatment Group
n=19 Participants
Will have a Unit of blood (two cups, the same amount donated at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure your blood count to be sure you are not anemic, and blood pressure to be sure no dehydration. During or after donation, a sports drink is provided to replace the fluid loss. Phlebotomy
Blood Donation: Participants in the TREATMENT GROUP will have a Unit of blood (two cups, the same amount you would donate at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure blood count to be sure participants are not anemic, and blood pressure to be sure there is no dehydration. During or after donation, participants will be given a sports drink to replace the fluid loss. Participants in the CONTROL GROUP will not donate blood, but will have a needle inserted into a vein in your arm. Neither group will not know to which they have been assigned, all will have a sleep mask (like a blindfold, covering the eyes, held on with an elastic band) placed so they will not know whether blood was actually removed.
|
Control Group
n=26 Participants
Will not donate blood, but will have a needle inserted into a vein in your arm. Both groups will not know which group assignment they have been randomized. Sham Phlebotomy
Sham Blood Donation: Participants will have a needle inserted their arm, however, no blood will be drawn.
|
|---|---|---|
|
Change in Weight
|
0.1 pounds
Standard Deviation 10.1
|
0.8 pounds
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: Baseline, Month 12The change in systolic Blood pressure from baseline to month 12 will be reported
Outcome measures
| Measure |
Treatment Group
n=19 Participants
Will have a Unit of blood (two cups, the same amount donated at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure your blood count to be sure you are not anemic, and blood pressure to be sure no dehydration. During or after donation, a sports drink is provided to replace the fluid loss. Phlebotomy
Blood Donation: Participants in the TREATMENT GROUP will have a Unit of blood (two cups, the same amount you would donate at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure blood count to be sure participants are not anemic, and blood pressure to be sure there is no dehydration. During or after donation, participants will be given a sports drink to replace the fluid loss. Participants in the CONTROL GROUP will not donate blood, but will have a needle inserted into a vein in your arm. Neither group will not know to which they have been assigned, all will have a sleep mask (like a blindfold, covering the eyes, held on with an elastic band) placed so they will not know whether blood was actually removed.
|
Control Group
n=26 Participants
Will not donate blood, but will have a needle inserted into a vein in your arm. Both groups will not know which group assignment they have been randomized. Sham Phlebotomy
Sham Blood Donation: Participants will have a needle inserted their arm, however, no blood will be drawn.
|
|---|---|---|
|
Change in Systolic Blood Pressure
|
2 mmHG
Standard Deviation 11
|
4 mmHG
Standard Deviation 11
|
SECONDARY outcome
Timeframe: Month 12Number of participants that converted from pre-Diabetes to Diabetes based on the HbA1C criteria.
Outcome measures
| Measure |
Treatment Group
n=19 Participants
Will have a Unit of blood (two cups, the same amount donated at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure your blood count to be sure you are not anemic, and blood pressure to be sure no dehydration. During or after donation, a sports drink is provided to replace the fluid loss. Phlebotomy
Blood Donation: Participants in the TREATMENT GROUP will have a Unit of blood (two cups, the same amount you would donate at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure blood count to be sure participants are not anemic, and blood pressure to be sure there is no dehydration. During or after donation, participants will be given a sports drink to replace the fluid loss. Participants in the CONTROL GROUP will not donate blood, but will have a needle inserted into a vein in your arm. Neither group will not know to which they have been assigned, all will have a sleep mask (like a blindfold, covering the eyes, held on with an elastic band) placed so they will not know whether blood was actually removed.
|
Control Group
n=26 Participants
Will not donate blood, but will have a needle inserted into a vein in your arm. Both groups will not know which group assignment they have been randomized. Sham Phlebotomy
Sham Blood Donation: Participants will have a needle inserted their arm, however, no blood will be drawn.
|
|---|---|---|
|
Number of Participants That Converted From Pre-diabetes to Diabetes
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Month 12Number of participants that converted from pre-Diabetes to normal glucose tolerance based on the HbA1C criteria.
Outcome measures
| Measure |
Treatment Group
n=19 Participants
Will have a Unit of blood (two cups, the same amount donated at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure your blood count to be sure you are not anemic, and blood pressure to be sure no dehydration. During or after donation, a sports drink is provided to replace the fluid loss. Phlebotomy
Blood Donation: Participants in the TREATMENT GROUP will have a Unit of blood (two cups, the same amount you would donate at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure blood count to be sure participants are not anemic, and blood pressure to be sure there is no dehydration. During or after donation, participants will be given a sports drink to replace the fluid loss. Participants in the CONTROL GROUP will not donate blood, but will have a needle inserted into a vein in your arm. Neither group will not know to which they have been assigned, all will have a sleep mask (like a blindfold, covering the eyes, held on with an elastic band) placed so they will not know whether blood was actually removed.
|
Control Group
n=26 Participants
Will not donate blood, but will have a needle inserted into a vein in your arm. Both groups will not know which group assignment they have been randomized. Sham Phlebotomy
Sham Blood Donation: Participants will have a needle inserted their arm, however, no blood will be drawn.
|
|---|---|---|
|
Number of Participants That Converted From Pre-diabetes to Normal Glucose Tolerance
|
1 Participants
|
1 Participants
|
Adverse Events
Treatment Group
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Control Group
Serious events: 3 serious events
Other events: 9 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment Group
n=64 participants at risk
Will have a Unit of blood (two cups, the same amount donated at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure your blood count to be sure you are not anemic, and blood pressure to be sure no dehydration. During or after donation, a sports drink is provided to replace the fluid loss. Phlebotomy
Blood Donation: Participants in the TREATMENT GROUP will have a Unit of blood (two cups, the same amount you would donate at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure blood count to be sure participants are not anemic, and blood pressure to be sure there is no dehydration. During or after donation, participants will be given a sports drink to replace the fluid loss. Participants in the CONTROL GROUP will not donate blood, but will have a needle inserted into a vein in your arm. Neither group will not know to which they have been assigned, all will have a sleep mask (like a blindfold, covering the eyes, held on with an elastic band) placed so they will not know whether blood was actually removed.
|
Control Group
n=68 participants at risk
Will not donate blood, but will have a needle inserted into a vein in your arm. Both groups will not know which group assignment they have been randomized. Sham Phlebotomy
Sham Blood Donation: Participants will have a needle inserted their arm, however, no blood will be drawn.
|
|---|---|---|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/64 • from baseline through month 12
|
1.5%
1/68 • Number of events 1 • from baseline through month 12
|
|
Surgical and medical procedures
Kidney Stone Surgery
|
0.00%
0/64 • from baseline through month 12
|
1.5%
1/68 • Number of events 1 • from baseline through month 12
|
|
Infections and infestations
E.coli
|
1.6%
1/64 • Number of events 1 • from baseline through month 12
|
0.00%
0/68 • from baseline through month 12
|
|
Injury, poisoning and procedural complications
Insulin Overdose
|
0.00%
0/64 • from baseline through month 12
|
1.5%
1/68 • Number of events 1 • from baseline through month 12
|
Other adverse events
| Measure |
Treatment Group
n=64 participants at risk
Will have a Unit of blood (two cups, the same amount donated at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure your blood count to be sure you are not anemic, and blood pressure to be sure no dehydration. During or after donation, a sports drink is provided to replace the fluid loss. Phlebotomy
Blood Donation: Participants in the TREATMENT GROUP will have a Unit of blood (two cups, the same amount you would donate at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure blood count to be sure participants are not anemic, and blood pressure to be sure there is no dehydration. During or after donation, participants will be given a sports drink to replace the fluid loss. Participants in the CONTROL GROUP will not donate blood, but will have a needle inserted into a vein in your arm. Neither group will not know to which they have been assigned, all will have a sleep mask (like a blindfold, covering the eyes, held on with an elastic band) placed so they will not know whether blood was actually removed.
|
Control Group
n=68 participants at risk
Will not donate blood, but will have a needle inserted into a vein in your arm. Both groups will not know which group assignment they have been randomized. Sham Phlebotomy
Sham Blood Donation: Participants will have a needle inserted their arm, however, no blood will be drawn.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Leg Cramps
|
1.6%
1/64 • Number of events 4 • from baseline through month 12
|
0.00%
0/68 • from baseline through month 12
|
|
General disorders
sleep apnea
|
0.00%
0/64 • from baseline through month 12
|
1.5%
1/68 • Number of events 1 • from baseline through month 12
|
|
Musculoskeletal and connective tissue disorders
right achilles tendonitis
|
1.6%
1/64 • Number of events 1 • from baseline through month 12
|
0.00%
0/68 • from baseline through month 12
|
|
General disorders
Right Knee Pain
|
0.00%
0/64 • from baseline through month 12
|
1.5%
1/68 • Number of events 4 • from baseline through month 12
|
|
Surgical and medical procedures
Right Knee Replacement Surgery
|
0.00%
0/64 • from baseline through month 12
|
1.5%
1/68 • Number of events 1 • from baseline through month 12
|
|
General disorders
Sciatica
|
1.6%
1/64 • Number of events 1 • from baseline through month 12
|
0.00%
0/68 • from baseline through month 12
|
|
Infections and infestations
Sinus Infection
|
0.00%
0/64 • from baseline through month 12
|
1.5%
1/68 • Number of events 1 • from baseline through month 12
|
|
Surgical and medical procedures
Toe Surgery
|
1.6%
1/64 • Number of events 1 • from baseline through month 12
|
0.00%
0/68 • from baseline through month 12
|
|
Surgical and medical procedures
Ulnar Nerve Surgery
|
1.6%
1/64 • Number of events 1 • from baseline through month 12
|
0.00%
0/68 • from baseline through month 12
|
|
Surgical and medical procedures
Eye Surgery
|
1.6%
1/64 • Number of events 1 • from baseline through month 12
|
0.00%
0/68 • from baseline through month 12
|
|
General disorders
Hemorrhoids
|
0.00%
0/64 • from baseline through month 12
|
1.5%
1/68 • Number of events 1 • from baseline through month 12
|
|
General disorders
Hip pain
|
1.6%
1/64 • Number of events 1 • from baseline through month 12
|
0.00%
0/68 • from baseline through month 12
|
|
Injury, poisoning and procedural complications
Broken Ankle
|
1.6%
1/64 • Number of events 1 • from baseline through month 12
|
0.00%
0/68 • from baseline through month 12
|
|
Injury, poisoning and procedural complications
Left Arm Soreness
|
1.6%
1/64 • Number of events 1 • from baseline through month 12
|
0.00%
0/68 • from baseline through month 12
|
|
Surgical and medical procedures
Cataract Surgery
|
1.6%
1/64 • Number of events 1 • from baseline through month 12
|
0.00%
0/68 • from baseline through month 12
|
|
Surgical and medical procedures
carpometacarpal joint surgery
|
1.6%
1/64 • Number of events 1 • from baseline through month 12
|
0.00%
0/68 • from baseline through month 12
|
|
Infections and infestations
Common Cold
|
3.1%
2/64 • Number of events 2 • from baseline through month 12
|
1.5%
1/68 • Number of events 1 • from baseline through month 12
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19
|
4.7%
3/64 • Number of events 3 • from baseline through month 12
|
2.9%
2/68 • Number of events 2 • from baseline through month 12
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/64 • from baseline through month 12
|
1.5%
1/68 • Number of events 1 • from baseline through month 12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place