Trial Outcomes & Findings for Skeletal Muscle Diacylglycerol and Sphingolipids - Impact of Localization and Species on Insulin Resistance in Humans (NCT NCT03077360)
NCT ID: NCT03077360
Last Updated: 2022-06-21
Results Overview
Hyperinsulinemic/euglycemic clamp measured as glucose infusion rate in mg/kg/min.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2022-06-21
Participant Flow
14 participants dropped out of the study prior to randomization.
Participant milestones
| Measure |
Weight Loss Only
Lifestyle: Lifestyle changes to lose weight or become more fit
|
Exercise Only
Lifestyle: Lifestyle changes to lose weight or become more fit
|
Delayed Intervention Control
Control group, no intervention. Participants were offered all benefits of the interventions after study completion.
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
14
|
|
Overall Study
COMPLETED
|
17
|
16
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Skeletal Muscle Diacylglycerol and Sphingolipids - Impact of Localization and Species on Insulin Resistance in Humans
Baseline characteristics by cohort
| Measure |
Weight Loss Only
n=17 Participants
Lifestyle: Lifestyle changes to lose weight or become more fit
|
Exercise Only
n=16 Participants
Lifestyle: Lifestyle changes to lose weight or become more fit
|
Delayed Intervention Control
n=12 Participants
Control group, no intervention. Participants were offered all benefits of the interventions after study completion.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.6 years
STANDARD_DEVIATION 2.4 • n=99 Participants
|
39.6 years
STANDARD_DEVIATION 3.1 • n=107 Participants
|
39.8 years
STANDARD_DEVIATION 2.7 • n=206 Participants
|
39.65 years
STANDARD_DEVIATION 2.5 • n=7 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
40 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
37 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=99 Participants
|
16 participants
n=107 Participants
|
12 participants
n=206 Participants
|
45 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksHyperinsulinemic/euglycemic clamp measured as glucose infusion rate in mg/kg/min.
Outcome measures
| Measure |
Weight Loss Only
n=17 Participants
Lifestyle: Lifestyle changes to lose weight or become more fit
|
Exercise Only
n=16 Participants
Lifestyle: Lifestyle changes to lose weight or become more fit
|
Delayed Intervention Control
n=12 Participants
Control group, no intervention. Participants were offered all benefits of the interventions after study completion.
|
|---|---|---|---|
|
Percent Change in Insulin Sensitivity Compared to Baseline Measurement.
|
31.8 Percent change
Standard Error 8.8
|
17.4 Percent change
Standard Error 8.7
|
-4.8 Percent change
Standard Error 9.3
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksWe measured changes in sarcolemmal, mitochondrial, nuclear and cytosolic lipids measured in pmol/ug protein after compared to before the interventions
Outcome measures
| Measure |
Weight Loss Only
n=18 Participants
Lifestyle: Lifestyle changes to lose weight or become more fit
|
Exercise Only
n=16 Participants
Lifestyle: Lifestyle changes to lose weight or become more fit
|
Delayed Intervention Control
n=12 Participants
Control group, no intervention. Participants were offered all benefits of the interventions after study completion.
|
|---|---|---|---|
|
Percent Change in Localized Muscle Lipids Compared to Baseline
Mitochondrial triglyceride
|
-25 percentage change
Standard Error 6
|
-30 percentage change
Standard Error 7
|
5 percentage change
Standard Error 6
|
|
Percent Change in Localized Muscle Lipids Compared to Baseline
Nuclear triglyceride
|
-20 percentage change
Standard Error 5
|
-25 percentage change
Standard Error 5
|
10 percentage change
Standard Error 3
|
|
Percent Change in Localized Muscle Lipids Compared to Baseline
Nuclear 1,2-Diacylglycerol
|
20 percentage change
Standard Error 4
|
25 percentage change
Standard Error 5
|
-5 percentage change
Standard Error 1
|
PRIMARY outcome
Timeframe: Baseline, 3 MonthsThis is the percent change in body weight for each group after the 12 week intervention.
Outcome measures
| Measure |
Weight Loss Only
n=17 Participants
Lifestyle: Lifestyle changes to lose weight or become more fit
|
Exercise Only
n=16 Participants
Lifestyle: Lifestyle changes to lose weight or become more fit
|
Delayed Intervention Control
n=12 Participants
Control group, no intervention. Participants were offered all benefits of the interventions after study completion.
|
|---|---|---|---|
|
Percent Change in Body Weight Compared to Baseline Measurement
|
-10.5 Percent
Standard Error 0.9
|
-0.5 Percent
Standard Error 0.5
|
0.5 Percent
Standard Error 0.4
|
Adverse Events
Weight Loss Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Exercise Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Delayed Intervention Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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