Trial Outcomes & Findings for The Effects of Potassium on Glucose Metabolism in African Americans (NCT NCT02236598)
NCT ID: NCT02236598
Last Updated: 2017-05-23
Results Overview
Change in glucose tolerance, as measured by change in glucose area-under-the-curve (Area Under the Curve (AUC) - measured via the trapezoidal method) of 2 hours from the 3-hour Oral Glucose Tolerance Test (OGTT).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
Baseline to 3 months
Results posted on
2017-05-23
Participant Flow
61 participants (17%) expressed interested in the study and signed informed consent. Of these, 29 participants were deemed eligible based on the results of the screening labs
Participant milestones
| Measure |
K+ Supplementation
K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months
K+ supplement
|
Placebo
Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months
Subjects will be instructed to take the pills
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
14
|
|
Overall Study
COMPLETED
|
15
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
K+ Supplementation
K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months
K+ supplement
|
Placebo
Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months
Subjects will be instructed to take the pills
Placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
The Effects of Potassium on Glucose Metabolism in African Americans
Baseline characteristics by cohort
| Measure |
K+ Supplementation
n=15 Participants
K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months
K+ supplement
|
Placebo
n=12 Participants
Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months
Subjects will be instructed to take the pills
Placebo
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.9 years
STANDARD_DEVIATION 11.0 • n=99 Participants
|
52.7 years
STANDARD_DEVIATION 8.9 • n=107 Participants
|
55.0 years
STANDARD_DEVIATION 10.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
12 participants
n=107 Participants
|
27 participants
n=206 Participants
|
|
BMI
|
34.3 kg/m2
STANDARD_DEVIATION 5.4 • n=99 Participants
|
35.1 kg/m2
STANDARD_DEVIATION 5.2 • n=107 Participants
|
34.8 kg/m2
STANDARD_DEVIATION 5.3 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to 3 monthsChange in glucose tolerance, as measured by change in glucose area-under-the-curve (Area Under the Curve (AUC) - measured via the trapezoidal method) of 2 hours from the 3-hour Oral Glucose Tolerance Test (OGTT).
Outcome measures
| Measure |
K+ Supplementation
n=15 Participants
K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months
K+ supplement
|
Placebo
n=12 Participants
Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months
Subjects will be instructed to take the pills
Placebo
|
|---|---|---|
|
Change in Glucose Tolerance as Measured by Area-under-the-curve
|
328 AUC - mg*min/dL
Standard Deviation 1779
|
1000 AUC - mg*min/dL
Standard Deviation 2378
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsChanges in fasting, 1-hour, and 2-hour post-challenge glucose levels in mg/dL
Outcome measures
| Measure |
K+ Supplementation
n=15 Participants
K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months
K+ supplement
|
Placebo
n=12 Participants
Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months
Subjects will be instructed to take the pills
Placebo
|
|---|---|---|
|
Changes in Fasting, 1-hour, and 2-hour Post-challenge Glucose Levels in mg/dL
Change in 2-Hour Glucose
|
3.60 mg/dL
Standard Deviation 25.82
|
0.75 mg/dL
Standard Deviation 24.53
|
|
Changes in Fasting, 1-hour, and 2-hour Post-challenge Glucose Levels in mg/dL
Change in Fasting Glucose
|
-1.0667 mg/dL
Standard Deviation 8.3961
|
6.0833 mg/dL
Standard Deviation 7.6093
|
|
Changes in Fasting, 1-hour, and 2-hour Post-challenge Glucose Levels in mg/dL
Change in 1-Hour Glucose
|
0.80 mg/dL
Standard Deviation 31.36
|
14.17 mg/dL
Standard Deviation 37.07
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsChanges in Insulin Secretion as measured by 2-hour insulin area-under-the-curve (AUC - measured via the trapezoidal method) of 2 hours from the 3-hour OGTT.
Outcome measures
| Measure |
K+ Supplementation
n=15 Participants
K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months
K+ supplement
|
Placebo
n=12 Participants
Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months
Subjects will be instructed to take the pills
Placebo
|
|---|---|---|
|
Changes in Insulin Secretion as Measured by 2-hour Insulin Area-under-the-curve (AUC)
|
71,444 AUC - pg*min/mL
Standard Deviation 213,221
|
149,327 AUC - pg*min/mL
Standard Deviation 378,900
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsMatsuda Insulin Sensitivity Index was calculated as: 10,000 / square root of \[fasting glucose x fasting insulin x mean glucose x mean insulin during Oral Glucose Tolerance Test\]).
Outcome measures
| Measure |
K+ Supplementation
n=15 Participants
K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months
K+ supplement
|
Placebo
n=12 Participants
Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months
Subjects will be instructed to take the pills
Placebo
|
|---|---|---|
|
Changes in Insulin Sensitivity
|
-0.03 AUC - unitless,
Standard Deviation 1.49
|
-0.87 AUC - unitless,
Standard Deviation 1.13
|
Adverse Events
K+ Supplementation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
K+ Supplementation
n=15 participants at risk
K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months
K+ supplement
|
Placebo
n=14 participants at risk
Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months
Subjects will be instructed to take the pills
Placebo
|
|---|---|---|
|
General disorders
Vasovagal Syncope
|
0.00%
0/15 • The reporting period for SAEs is from the day of randomization and receipt of study medication through 12-week end-of-study visit.
|
7.1%
1/14 • Number of events 1 • The reporting period for SAEs is from the day of randomization and receipt of study medication through 12-week end-of-study visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place