Trial Outcomes & Findings for Protection Against Insulin Resistance in Obesity (NCT NCT02717832)
NCT ID: NCT02717832
Last Updated: 2022-05-11
Results Overview
A hyperinsulinemic-euglycemic clamp will be used to assess peripheral insulin sensitivity
COMPLETED
NA
26 participants
baseline (this cross-sectional study involves only one insulin sensitivity measurement in a single visit for each participant)
2022-05-11
Participant Flow
Participant milestones
| Measure |
Insulin Sensitivity
hyperinsulinemic-euglycemic clamp
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Insulin Sensitivity
hyperinsulinemic-euglycemic clamp
|
|---|---|
|
Overall Study
Inability to place IV
|
3
|
Baseline Characteristics
Protection Against Insulin Resistance in Obesity
Baseline characteristics by cohort
| Measure |
Insulin Sensitivity
n=20 Participants
hyperinsulinemic-euglycemic clamp
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline (this cross-sectional study involves only one insulin sensitivity measurement in a single visit for each participant)Population: BMI: 30-40 kg/m2; waist circumference: 88-98cm for women and 100-110cm for men), age: 18-45 years old), weight stable (±3kg for ≥ 6 months), No medications known to affect lipid or glucose metabolism. No evidence and/or history of cardiovascular or metabolic diseases All women were pre-menopausal with regularly occurring menses.
A hyperinsulinemic-euglycemic clamp will be used to assess peripheral insulin sensitivity
Outcome measures
| Measure |
Low Insulin Sensitivity Group
n=10 Participants
Adults with obesity with a rate of glucose disappearance from plasma (Rd Glucose) \< 400 nmol/kg fat free mass/min/(uU/ml Insulin)
|
High Insulin Sensitivity Group
n=7 Participants
Adults with obesity with a rate of glucose disappearance from plasma (Rd Glucose) \>550 nmol/kg fat free mass/min/(uU/ml Insulin)
|
|---|---|---|
|
Insulin Sensitivity
|
273 nmol/kg FFM/min /(µU/mL Insulin)
Standard Deviation 54
|
817 nmol/kg FFM/min /(µU/mL Insulin)
Standard Deviation 257
|
SECONDARY outcome
Timeframe: baseline (this cross-sectional study involves only one Resting Metabolic Rate measurement in a single visit for each participant)Population: BMI: 30-40 kg/m2; waist circumference: 88-98cm for women and 100-110cm for men), age: 18-45 years old), weight stable (±3kg for ≥ 6 months), No medications known to affect lipid or glucose metabolism. No evidence and/or history of cardiovascular or metabolic diseases All women were pre-menopausal with regularly occurring menses.
Resting metabolic rate was measured using a metabolic cart (to measure VO2 and VCO2) in the morning after an overnight fast
Outcome measures
| Measure |
Low Insulin Sensitivity Group
n=8 Participants
Adults with obesity with a rate of glucose disappearance from plasma (Rd Glucose) \< 400 nmol/kg fat free mass/min/(uU/ml Insulin)
|
High Insulin Sensitivity Group
n=6 Participants
Adults with obesity with a rate of glucose disappearance from plasma (Rd Glucose) \>550 nmol/kg fat free mass/min/(uU/ml Insulin)
|
|---|---|---|
|
Resting Metabolic Rate
|
1509 kcals/day
Standard Deviation 237
|
1325 kcals/day
Standard Deviation 198
|
Adverse Events
Insulin Sensitivity
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place