Trial Outcomes & Findings for Fatty Acid Oxidation Defects and Insulin Sensitivity (NCT NCT02517307)
NCT ID: NCT02517307
Last Updated: 2024-01-30
Results Overview
Insulin infusion induces glucose disposal into muscle and adipose tissue in insulin sensitive participants. During the glycerol co-infusion, glucose disposal will be high. Intralipid co-infusion can induce a temporary insulin resistant state. During the intralipid co-infusion, glucose disposal will be decreased. We are comparing how intralipid dampens glucose disposal between participants with a FAOD and matched control participants. Glucose disposal is measured by measuring the ratio of deuterated glucose to unlabeled glucose at the beginning and end of the clamp. The calculated glucose disposal rate or RD is mg of glucose taken into muscle and adipose tissue per minute.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
Calculated during the last 30 minutes of a 300 minute clamp.
Results posted on
2024-01-30
Participant Flow
2 control participants were recruited between February 2016 and June 2016 to complete testing of the protocol procedures. Adjustments to clamp, MRS and biopsy protocols were made and a final manual of operating procedures developed. These 2 participants were not included in the final data analysis. Then, 23 participants with a FAOD were screened for eligibility from June 2016 to August 2019. 27 control participants were screened for eligibility from July 2016 to February 2020.
2 initial control participants who did not have a comparable FAO matched participant completed the protocol procedures to establish the final protocol; the data was not included in the final analysis. 23 participants with a FAOD were randomized. Of those randomized, 2 did not meet inclusion criteria, and 2 declined to participate. 27 control participants were randomized. Of those randomized, 2 did not meet inclusion criteria and 3 declined to participate.
Participant milestones
| Measure |
FAOD Glycerol Then Intralipid
Participants with a FAOD first complete a hyperinsulinemic euglycemic clamp with a co-infusion of glycerol. After a wash-out of 4 months, they then complete a a hyperinsulinemic euglycemic clamp with a co-infusion of intralipid.
|
FAOD Intralipid Then Glycerol
Participants with a FAOD first complete a hyperinsulinemic euglycemic clamp with a co-infusion of intralipid. After a wash-out of 4 months, they then complete a a hyperinsulinemic euglycemic clamp with a co-infusion of glycerol.
|
Control Glycerol Then Intralipid
Matched normal control participants first complete a hyperinsulinemic euglycemic clamp with a co-infusion of glycerol. After a wash-out of 4 months, they then complete a a hyperinsulinemic euglycemic clamp with a co-infusion of intralipid.
|
Control Intralipid Then Glycerol
Matched normal control participants first complete a hyperinsulinemic euglycemic clamp with a co-infusion of intralipid. After a wash-out of 4 months, they then complete a a hyperinsulinemic euglycemic clamp with a co-infusion of glycerol.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
8
|
11
|
11
|
|
Overall Study
COMPLETED
|
10
|
8
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
FAOD Glycerol Then Intralipid
Participants with a FAOD first complete a hyperinsulinemic euglycemic clamp with a co-infusion of glycerol. After a wash-out of 4 months, they then complete a a hyperinsulinemic euglycemic clamp with a co-infusion of intralipid.
|
FAOD Intralipid Then Glycerol
Participants with a FAOD first complete a hyperinsulinemic euglycemic clamp with a co-infusion of intralipid. After a wash-out of 4 months, they then complete a a hyperinsulinemic euglycemic clamp with a co-infusion of glycerol.
|
Control Glycerol Then Intralipid
Matched normal control participants first complete a hyperinsulinemic euglycemic clamp with a co-infusion of glycerol. After a wash-out of 4 months, they then complete a a hyperinsulinemic euglycemic clamp with a co-infusion of intralipid.
|
Control Intralipid Then Glycerol
Matched normal control participants first complete a hyperinsulinemic euglycemic clamp with a co-infusion of intralipid. After a wash-out of 4 months, they then complete a a hyperinsulinemic euglycemic clamp with a co-infusion of glycerol.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Fatty Acid Oxidation Defects and Insulin Sensitivity
Baseline characteristics by cohort
| Measure |
FAOD Glycerol Then Intralipid
n=11 Participants
Participants with a FAOD first complete a hyperinsulinemic euglycemic clamp with a co-infusion of glycerol. After a wash-out of 4 months, they then complete a a hyperinsulinemic euglycemic clamp with a co-infusion of intralipid.
|
FAOD Intralipid Then Glycerol
n=8 Participants
Participants with a FAOD first complete a hyperinsulinemic euglycemic clamp with a co-infusion of intralipid. After a wash-out of 4 months, they then complete a a hyperinsulinemic euglycemic clamp with a co-infusion of glycerol.
|
Control Glycerol Then Intralipid
n=11 Participants
Matched control participants first complete a hyperinsulinemic euglycemic clamp with a co-infusion of glycerol. After a wash-out of 4 months, they then complete a a hyperinsulinemic euglycemic clamp with a co-infusion of intralipid.
|
Control Intralipid Then Glycerol
n=11 Participants
Matched control participants first complete a hyperinsulinemic euglycemic clamp with a co-infusion of intralipid. After a wash-out of 4 months, they then complete a a hyperinsulinemic euglycemic clamp with a co-infusion of glycerol.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
41 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
32.0 years
STANDARD_DEVIATION 12.7 • n=99 Participants
|
23.0 years
STANDARD_DEVIATION 4.3 • n=107 Participants
|
33.8 years
STANDARD_DEVIATION 9.4 • n=206 Participants
|
29.9 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
29.32 years
STANDARD_DEVIATION 9.48 • n=31 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
25 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
32 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 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
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
28 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
8 participants
n=107 Participants
|
11 participants
n=206 Participants
|
11 participants
n=7 Participants
|
41 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Calculated during the last 30 minutes of a 300 minute clamp.Population: 1 participant with a FAOD withdrew after completing the glycerol clamp . 2 control participants completed the protocol to establish the study procedures, but are not included in the statistical analysis. 1 control participants withdrew and 1 was discontinued leaving 18 participants data for the intralipid clamp. In addition, 1 other control was discontinued and 1 control had technical challenges during the glycerol clamp leaving 16 control participants data for glycerol clamp.
Insulin infusion induces glucose disposal into muscle and adipose tissue in insulin sensitive participants. During the glycerol co-infusion, glucose disposal will be high. Intralipid co-infusion can induce a temporary insulin resistant state. During the intralipid co-infusion, glucose disposal will be decreased. We are comparing how intralipid dampens glucose disposal between participants with a FAOD and matched control participants. Glucose disposal is measured by measuring the ratio of deuterated glucose to unlabeled glucose at the beginning and end of the clamp. The calculated glucose disposal rate or RD is mg of glucose taken into muscle and adipose tissue per minute.
Outcome measures
| Measure |
Glycerol/Saline FAOD
n=19 Participants
Glycerol/Saline co-infusion hyperinsulinemic euglycemic clamp among subjects with a fatty acid oxidation disorder (FAOD)
Glycerol/Saline: Co-infusion of a glycerol/saline solutions during a hyperinsulinemic euglycemic clamp
Hyperinsulinemic euglycemic clamp: Infusion of insulin at at 40 mU/m2/min for 5 hours. Blood glucose will be monitored every 5 min during the insulin infusion and euglycemia will be maintained throughout the clamp by infusing 20% dextrose at a variable rate.
|
Intralipid FAOD
n=18 Participants
Intralipid/Heparin co-infusion hyperinsulinemic euglycemic clamp among subjects with a fatty acid oxidation disorder (FAOD)
Intralipid/Heparin: Co-infusion of intralipid and heparin solutions during a hyperinsulinemic euglycemic clamp
Hyperinsulinemic euglycemic clamp: Infusion of insulin at at 40 mU/m2/min for 5 hours. Blood glucose will be monitored every 5 min during the insulin infusion and euglycemia will be maintained throughout the clamp by infusing 20% dextrose at a variable rate.
|
Glycerol/Saline Control
n=16 Participants
Glycerol/Saline co-infusion hyperinsulinemic euglycemic clamp among normal matched control subjects (control)
Glycerol/Saline: Co-infusion of a glycerol/saline solutions during a hyperinsulinemic euglycemic clamp
Hyperinsulinemic euglycemic clamp: Infusion of insulin at at 40 mU/m2/min for 5 hours. Blood glucose will be monitored every 5 min during the insulin infusion and euglycemia will be maintained throughout the clamp by infusing 20% dextrose at a variable rate.
|
Intralipid Control
n=18 Participants
Intralipid/Heparin co-infusion hyperinsulinemic euglycemic clamp among normal matched control subjects (control)
Intralipid/Heparin: Co-infusion of intralipid and heparin solutions during a hyperinsulinemic euglycemic clamp
Hyperinsulinemic euglycemic clamp: Infusion of insulin at at 40 mU/m2/min for 5 hours. Blood glucose will be monitored every 5 min during the insulin infusion and euglycemia will be maintained throughout the clamp by infusing 20% dextrose at a variable rate.
|
|---|---|---|---|---|
|
Glucose Disposal Rate (Rd)- the Rate of Glucose Infusion to Maintain Euglycemia During Steady State Insulin Infusion in mg/Min
|
709 mg/min
Standard Deviation 244
|
429 mg/min
Standard Deviation 297
|
842 mg/min
Standard Deviation 282
|
497 mg/min
Standard Deviation 297
|
SECONDARY outcome
Timeframe: Calculated during the last 30 minutes of a 300 minute clamp.Population: 1 participant with a FAOD withdrew after completing the glycerol clamp . 2 control participants completed the protocol to establish the study procedures, but are not included in the statistical analysis. 1 control withdrew and 1 was discontinued leaving 18 participants data for the intralipid clamp. In addition, 1 other control was discontinued and 1 control had technical challenges during the glycerol clamp leaving 16 control participants data for the glycerol clamp.
Infusion of insulin will suppress endogenous glucose production from the liver in insulin sensitive people. Insulin infusion with glycerol should suppress the endogenous glucose production in the liver but intralipid induces a temporary state of insulin resistance and the decrease in endogenous glucose production or Ra will be blunted with intralipid co-infusion. We are looking at the difference in Ra with intralipid between participants with a FAOD and matched control participants. Ra or endogenous glucose production during high insulin is measured in mg new glucose synthesized per minute.
Outcome measures
| Measure |
Glycerol/Saline FAOD
n=19 Participants
Glycerol/Saline co-infusion hyperinsulinemic euglycemic clamp among subjects with a fatty acid oxidation disorder (FAOD)
Glycerol/Saline: Co-infusion of a glycerol/saline solutions during a hyperinsulinemic euglycemic clamp
Hyperinsulinemic euglycemic clamp: Infusion of insulin at at 40 mU/m2/min for 5 hours. Blood glucose will be monitored every 5 min during the insulin infusion and euglycemia will be maintained throughout the clamp by infusing 20% dextrose at a variable rate.
|
Intralipid FAOD
n=18 Participants
Intralipid/Heparin co-infusion hyperinsulinemic euglycemic clamp among subjects with a fatty acid oxidation disorder (FAOD)
Intralipid/Heparin: Co-infusion of intralipid and heparin solutions during a hyperinsulinemic euglycemic clamp
Hyperinsulinemic euglycemic clamp: Infusion of insulin at at 40 mU/m2/min for 5 hours. Blood glucose will be monitored every 5 min during the insulin infusion and euglycemia will be maintained throughout the clamp by infusing 20% dextrose at a variable rate.
|
Glycerol/Saline Control
n=16 Participants
Glycerol/Saline co-infusion hyperinsulinemic euglycemic clamp among normal matched control subjects (control)
Glycerol/Saline: Co-infusion of a glycerol/saline solutions during a hyperinsulinemic euglycemic clamp
Hyperinsulinemic euglycemic clamp: Infusion of insulin at at 40 mU/m2/min for 5 hours. Blood glucose will be monitored every 5 min during the insulin infusion and euglycemia will be maintained throughout the clamp by infusing 20% dextrose at a variable rate.
|
Intralipid Control
n=18 Participants
Intralipid/Heparin co-infusion hyperinsulinemic euglycemic clamp among normal matched control subjects (control)
Intralipid/Heparin: Co-infusion of intralipid and heparin solutions during a hyperinsulinemic euglycemic clamp
Hyperinsulinemic euglycemic clamp: Infusion of insulin at at 40 mU/m2/min for 5 hours. Blood glucose will be monitored every 5 min during the insulin infusion and euglycemia will be maintained throughout the clamp by infusing 20% dextrose at a variable rate.
|
|---|---|---|---|---|
|
Endogenous Glucose Production (Ra) - Calculated by the Equations of Steele During Steady State in mg/Min
|
84.7 mg/min
Standard Deviation 38.4
|
97.2 mg/min
Standard Deviation 44.0
|
50.2 mg/min
Standard Deviation 42.0
|
106 mg/min
Standard Deviation 37.0
|
Adverse Events
Glycerol/Saline FAOD
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Intralipid FAOD
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Glycerol/Saline Control
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Intralipid Control
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Glycerol/Saline FAOD
n=19 participants at risk
Glycerol/Saline co-infusion hyperinsulinemic euglycemic clamp among subjects with a fatty acid oxidation disorder (FAOD)
Glycerol/Saline: Co-infusion of a glycerol/saline solutions during a hyperinsulinemic euglycemic clamp
Hyperinsulinemic euglycemic clamp: Infusion of insulin at at 40 mU/m2/min for 5 hours. Blood glucose will be monitored every 5 min during the insulin infusion and euglycemia will be maintained throughout the clamp by infusing 20% dextrose at a variable rate.
|
Intralipid FAOD
n=18 participants at risk
Intralipid/Heparin co-infusion hyperinsulinemic euglycemic clamp among subjects with a fatty acid oxidation disorder (FAOD)
Intralipid/Heparin: Co-infusion of intralipid and heparin solutions during a hyperinsulinemic euglycemic clamp
Hyperinsulinemic euglycemic clamp: Infusion of insulin at at 40 mU/m2/min for 5 hours. Blood glucose will be monitored every 5 min during the insulin infusion and euglycemia will be maintained throughout the clamp by infusing 20% dextrose at a variable rate.
|
Glycerol/Saline Control
n=20 participants at risk
Glycerol/Saline co-infusion hyperinsulinemic euglycemic clamp among normal matched control subjects (control)
Glycerol/Saline: Co-infusion of a glycerol/saline solutions during a hyperinsulinemic euglycemic clamp
Hyperinsulinemic euglycemic clamp: Infusion of insulin at at 40 mU/m2/min for 5 hours. Blood glucose will be monitored every 5 min during the insulin infusion and euglycemia will be maintained throughout the clamp by infusing 20% dextrose at a variable rate.
|
Intralipid Control
n=21 participants at risk
Intralipid/Heparin co-infusion hyperinsulinemic euglycemic clamp among normal matched control subjects (control)
Intralipid/Heparin: Co-infusion of intralipid and heparin solutions during a hyperinsulinemic euglycemic clamp
Hyperinsulinemic euglycemic clamp: Infusion of insulin at at 40 mU/m2/min for 5 hours. Blood glucose will be monitored every 5 min during the insulin infusion and euglycemia will be maintained throughout the clamp by infusing 20% dextrose at a variable rate.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
5.3%
1/19 • Number of events 1 • 3 months for each intervention
|
0.00%
0/18 • 3 months for each intervention
|
0.00%
0/20 • 3 months for each intervention
|
0.00%
0/21 • 3 months for each intervention
|
|
Infections and infestations
Urinary Tract Infection/Kidney Infection
|
0.00%
0/19 • 3 months for each intervention
|
5.6%
1/18 • Number of events 1 • 3 months for each intervention
|
0.00%
0/20 • 3 months for each intervention
|
4.8%
1/21 • Number of events 1 • 3 months for each intervention
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/19 • 3 months for each intervention
|
5.6%
1/18 • Number of events 1 • 3 months for each intervention
|
0.00%
0/20 • 3 months for each intervention
|
0.00%
0/21 • 3 months for each intervention
|
Other adverse events
| Measure |
Glycerol/Saline FAOD
n=19 participants at risk
Glycerol/Saline co-infusion hyperinsulinemic euglycemic clamp among subjects with a fatty acid oxidation disorder (FAOD)
Glycerol/Saline: Co-infusion of a glycerol/saline solutions during a hyperinsulinemic euglycemic clamp
Hyperinsulinemic euglycemic clamp: Infusion of insulin at at 40 mU/m2/min for 5 hours. Blood glucose will be monitored every 5 min during the insulin infusion and euglycemia will be maintained throughout the clamp by infusing 20% dextrose at a variable rate.
|
Intralipid FAOD
n=18 participants at risk
Intralipid/Heparin co-infusion hyperinsulinemic euglycemic clamp among subjects with a fatty acid oxidation disorder (FAOD)
Intralipid/Heparin: Co-infusion of intralipid and heparin solutions during a hyperinsulinemic euglycemic clamp
Hyperinsulinemic euglycemic clamp: Infusion of insulin at at 40 mU/m2/min for 5 hours. Blood glucose will be monitored every 5 min during the insulin infusion and euglycemia will be maintained throughout the clamp by infusing 20% dextrose at a variable rate.
|
Glycerol/Saline Control
n=20 participants at risk
Glycerol/Saline co-infusion hyperinsulinemic euglycemic clamp among normal matched control subjects (control)
Glycerol/Saline: Co-infusion of a glycerol/saline solutions during a hyperinsulinemic euglycemic clamp
Hyperinsulinemic euglycemic clamp: Infusion of insulin at at 40 mU/m2/min for 5 hours. Blood glucose will be monitored every 5 min during the insulin infusion and euglycemia will be maintained throughout the clamp by infusing 20% dextrose at a variable rate.
|
Intralipid Control
n=21 participants at risk
Intralipid/Heparin co-infusion hyperinsulinemic euglycemic clamp among normal matched control subjects (control)
Intralipid/Heparin: Co-infusion of intralipid and heparin solutions during a hyperinsulinemic euglycemic clamp
Hyperinsulinemic euglycemic clamp: Infusion of insulin at at 40 mU/m2/min for 5 hours. Blood glucose will be monitored every 5 min during the insulin infusion and euglycemia will be maintained throughout the clamp by infusing 20% dextrose at a variable rate.
|
|---|---|---|---|---|
|
General disorders
Headache
|
15.8%
3/19 • Number of events 4 • 3 months for each intervention
|
11.1%
2/18 • Number of events 2 • 3 months for each intervention
|
5.0%
1/20 • Number of events 1 • 3 months for each intervention
|
9.5%
2/21 • Number of events 2 • 3 months for each intervention
|
|
Surgical and medical procedures
Pain at muscle biopsy site
|
47.4%
9/19 • Number of events 9 • 3 months for each intervention
|
50.0%
9/18 • Number of events 9 • 3 months for each intervention
|
25.0%
5/20 • Number of events 5 • 3 months for each intervention
|
23.8%
5/21 • Number of events 5 • 3 months for each intervention
|
|
Surgical and medical procedures
Pain at fat biopsy site
|
10.5%
2/19 • Number of events 2 • 3 months for each intervention
|
5.6%
1/18 • Number of events 1 • 3 months for each intervention
|
20.0%
4/20 • Number of events 4 • 3 months for each intervention
|
9.5%
2/21 • Number of events 2 • 3 months for each intervention
|
|
Infections and infestations
Upper respiratory infection/colds
|
21.1%
4/19 • Number of events 4 • 3 months for each intervention
|
11.1%
2/18 • Number of events 2 • 3 months for each intervention
|
5.0%
1/20 • Number of events 1 • 3 months for each intervention
|
9.5%
2/21 • Number of events 2 • 3 months for each intervention
|
|
Infections and infestations
UTI
|
10.5%
2/19 • Number of events 2 • 3 months for each intervention
|
0.00%
0/18 • 3 months for each intervention
|
0.00%
0/20 • 3 months for each intervention
|
0.00%
0/21 • 3 months for each intervention
|
|
General disorders
allergic reaction
|
0.00%
0/19 • 3 months for each intervention
|
5.6%
1/18 • Number of events 1 • 3 months for each intervention
|
5.0%
1/20 • Number of events 1 • 3 months for each intervention
|
0.00%
0/21 • 3 months for each intervention
|
|
Gastrointestinal disorders
Emesis, Diarrhea, GI upset, Nausea
|
5.3%
1/19 • Number of events 1 • 3 months for each intervention
|
16.7%
3/18 • Number of events 3 • 3 months for each intervention
|
15.0%
3/20 • Number of events 3 • 3 months for each intervention
|
19.0%
4/21 • Number of events 5 • 3 months for each intervention
|
|
Surgical and medical procedures
Hematoma at fat biopsy site
|
10.5%
2/19 • Number of events 2 • 3 months for each intervention
|
11.1%
2/18 • Number of events 2 • 3 months for each intervention
|
15.0%
3/20 • Number of events 3 • 3 months for each intervention
|
9.5%
2/21 • Number of events 2 • 3 months for each intervention
|
|
Surgical and medical procedures
Bleeding or bruising at biopsy sites
|
0.00%
0/19 • 3 months for each intervention
|
0.00%
0/18 • 3 months for each intervention
|
0.00%
0/20 • 3 months for each intervention
|
19.0%
4/21 • Number of events 6 • 3 months for each intervention
|
|
General disorders
Tooth pain
|
10.5%
2/19 • Number of events 2 • 3 months for each intervention
|
0.00%
0/18 • 3 months for each intervention
|
0.00%
0/20 • 3 months for each intervention
|
0.00%
0/21 • 3 months for each intervention
|
|
Nervous system disorders
Syncopal episode
|
0.00%
0/19 • 3 months for each intervention
|
11.1%
2/18 • Number of events 2 • 3 months for each intervention
|
0.00%
0/20 • 3 months for each intervention
|
0.00%
0/21 • 3 months for each intervention
|
|
Musculoskeletal and connective tissue disorders
general pain
|
10.5%
2/19 • Number of events 2 • 3 months for each intervention
|
16.7%
3/18 • Number of events 3 • 3 months for each intervention
|
0.00%
0/20 • 3 months for each intervention
|
0.00%
0/21 • 3 months for each intervention
|
|
Endocrine disorders
hypoglycemia during clamp
|
0.00%
0/19 • 3 months for each intervention
|
0.00%
0/18 • 3 months for each intervention
|
5.0%
1/20 • Number of events 1 • 3 months for each intervention
|
0.00%
0/21 • 3 months for each intervention
|
|
Surgical and medical procedures
IV infiltration or phlebitis
|
5.3%
1/19 • Number of events 1 • 3 months for each intervention
|
0.00%
0/18 • 3 months for each intervention
|
5.0%
1/20 • Number of events 1 • 3 months for each intervention
|
0.00%
0/21 • 3 months for each intervention
|
|
Reproductive system and breast disorders
heavy menstrual cycles
|
0.00%
0/19 • 3 months for each intervention
|
0.00%
0/18 • 3 months for each intervention
|
0.00%
0/20 • 3 months for each intervention
|
4.8%
1/21 • Number of events 1 • 3 months for each intervention
|
Additional Information
Melanie Gillingham, PhD
Oregon Health & Science University
Phone: 503-494-1682
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place