Trial Outcomes & Findings for Molecular Mechanisms of Exercise Benefits to Insulin Resistant People (NCT NCT04158375)
NCT ID: NCT04158375
Last Updated: 2025-11-25
Results Overview
Change in 1RM normalized to lean mass
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
58 participants
Primary outcome timeframe
Baseline and 3 Months
Results posted on
2025-11-25
Participant Flow
Participant milestones
| Measure |
Insulin Resistant Exercise Group
Resistance (RE) training will be performed 4 days per week using a combination of upper and lower body exercises at 8-12 repetitions per set. Resistance training will be performed using a combination of upper and lower body exercises using machine and free weights. Upper body exercises are chest press, incline press, seated row, lat pull down, triceps extension, biceps curl and lateral raises. Major muscle groups for upper body exercises will include chest (pectoralis major and minor), arm (biceps and triceps), shoulder (deltoids) and back (latissimus dorsi and rhomboids). Lower body exercises are leg press, lunge (with body weight progressing to dumbbells), seated leg extension, seated leg curl, calf raises and abdominal crunches. Major muscle groups for the lower body exercises will be thighs (quadriceps and hamstrings), calves (gastrocnemius and soleus) and core (rectus abdominus and obliques). Participants will complete 2 progressing to 4 sets, with 1 minute rest between sets. Participants will warmup. Resistance will be performed 4 days per week with lower body exercise on Monday and Thursday, and upper body on Tuesday and Friday. Wednesdays are a rest day. Participants will begin at 2 sets per exercise on weeks 1 and 2, then 3 sets for week 3, and 4 sets for weeks 4 to 12.
|
Insulin Resistant Control Group
Participants in this group will perform no exercise for the 3 month study period.
|
Insulin Sensitive Lean Group
Participants in this group will have a baseline study for comparison to the insulin resistant groups.
|
|---|---|---|---|
|
Overall Study
STARTED
|
33
|
16
|
9
|
|
Overall Study
COMPLETED
|
33
|
13
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
0
|
Reasons for withdrawal
| Measure |
Insulin Resistant Exercise Group
Resistance (RE) training will be performed 4 days per week using a combination of upper and lower body exercises at 8-12 repetitions per set. Resistance training will be performed using a combination of upper and lower body exercises using machine and free weights. Upper body exercises are chest press, incline press, seated row, lat pull down, triceps extension, biceps curl and lateral raises. Major muscle groups for upper body exercises will include chest (pectoralis major and minor), arm (biceps and triceps), shoulder (deltoids) and back (latissimus dorsi and rhomboids). Lower body exercises are leg press, lunge (with body weight progressing to dumbbells), seated leg extension, seated leg curl, calf raises and abdominal crunches. Major muscle groups for the lower body exercises will be thighs (quadriceps and hamstrings), calves (gastrocnemius and soleus) and core (rectus abdominus and obliques). Participants will complete 2 progressing to 4 sets, with 1 minute rest between sets. Participants will warmup. Resistance will be performed 4 days per week with lower body exercise on Monday and Thursday, and upper body on Tuesday and Friday. Wednesdays are a rest day. Participants will begin at 2 sets per exercise on weeks 1 and 2, then 3 sets for week 3, and 4 sets for weeks 4 to 12.
|
Insulin Resistant Control Group
Participants in this group will perform no exercise for the 3 month study period.
|
Insulin Sensitive Lean Group
Participants in this group will have a baseline study for comparison to the insulin resistant groups.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
0
|
Baseline Characteristics
Molecular Mechanisms of Exercise Benefits to Insulin Resistant People
Baseline characteristics by cohort
| Measure |
Insulin Resistant Exercise Group
n=33 Participants
Resistance (RE) training will be performed 4 days per week using a combination of upper and lower body exercises at 8-12 repetitions per set. Resistance training will be performed using a combination of upper and lower body exercises using machine and free weights. Upper body exercises are chest press, incline press, seated row, lat pull down, triceps extension, biceps curl and lateral raises. Major muscle groups for upper body exercises will include chest (pectoralis major and minor), arm (biceps and triceps), shoulder (deltoids) and back (latissimus dorsi and rhomboids). Lower body exercises are leg press, lunge (with body weight progressing to dumbbells), seated leg extension, seated leg curl, calf raises and abdominal crunches. Major muscle groups for the lower body exercises will be thighs (quadriceps and hamstrings), calves (gastrocnemius and soleus) and core (rectus abdominus and obliques). Participants will complete 2 progressing to 4 sets, with 1 minute rest between sets. Participants will warmup. Resistance will be performed 4 days per week with lower body exercise on Monday and Thursday, and upper body on Tuesday and Friday. Wednesdays are a rest day. Participants will begin at 2 sets per exercise on weeks 1 and 2, then 3 sets for week 3, and 4 sets for weeks 4 to 12.
|
Insulin Resistant Control Group
n=13 Participants
Participants in this group will perform no exercise for the 3 month study period.
|
Insulin Sensitive Lean Group
n=9 Participants
Participants in this group will have a baseline study for comparison to the insulin resistant groups.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=45 Participants
|
10 Participants
n=12929 Participants
|
4 Participants
n=6349 Participants
|
37 Participants
n=4548 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=45 Participants
|
3 Participants
n=12929 Participants
|
5 Participants
n=6349 Participants
|
18 Participants
n=4548 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=45 Participants
|
7 Participants
n=12929 Participants
|
5 Participants
n=6349 Participants
|
29 Participants
n=4548 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=45 Participants
|
6 Participants
n=12929 Participants
|
4 Participants
n=6349 Participants
|
26 Participants
n=4548 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
1 Participants
n=6349 Participants
|
3 Participants
n=4548 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=45 Participants
|
12 Participants
n=12929 Participants
|
8 Participants
n=6349 Participants
|
52 Participants
n=4548 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=45 Participants
|
13 Participants
n=12929 Participants
|
9 Participants
n=6349 Participants
|
55 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Region of Enrollment
United States
|
33 Participants
n=45 Participants
|
13 Participants
n=12929 Participants
|
9 Participants
n=6349 Participants
|
55 Participants
n=4548 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 MonthsPopulation: Only longitudinal arms were analyzed since this is a measure of change between baseline and 3 months (Insulin Resistant Exercise Group vs Insulin Resistant Control Group). The Insulin Sensitive Lean Group was only for baseline comparisons.
Change in 1RM normalized to lean mass
Outcome measures
| Measure |
Insulin Resistant Exercise Group
n=32 Participants
Resistance (RE) training will be performed 4 days per week using a combination of upper and lower body exercises at 8-12 repetitions per set. Resistance training will be performed using a combination of upper and lower body exercises using machine and free weights. Upper body exercises are chest press, incline press, seated row, lat pull down, triceps extension, biceps curl and lateral raises. Major muscle groups for upper body exercises will include chest (pectoralis major and minor), arm (biceps and triceps), shoulder (deltoids) and back (latissimus dorsi and rhomboids). Lower body exercises are leg press, lunge (with body weight progressing to dumbbells), seated leg extension, seated leg curl, calf raises and abdominal crunches. Major muscle groups for the lower body exercises will be thighs (quadriceps and hamstrings), calves (gastrocnemius and soleus) and core (rectus abdominus and obliques).
Resistance Exercise: Resistance (RE) training will be performed 4 days per week using a combination of upper and lower body exercises at 8-12 repetitions per set. Participants will complete 2 progressing to 4 sets of 8 to 12 repetitions per exercise, with 1 minute rest between sets. Participants will warmup for 5 minutes on a treadmill, cycle ergometer or elliptical at \~50% VO2 peak then begin resistance training. Participants will begin at 2 sets per exercise on weeks 1 and 2, then 3 sets for week 3, and 4 sets for weeks 4 to 12.
|
Insulin Resistant Control Group
n=15 Participants
Participants in this group will perform no exercise for the 3 month study period.
|
|---|---|---|
|
Change in Muscle Strength
|
0.37 Ratio
Standard Deviation 0.31
|
-0.2 Ratio
Standard Deviation 0.32
|
PRIMARY outcome
Timeframe: Baseline and 3 MonthsPopulation: Only longitudinal arms were analyzed since this is a measure of change between baseline and 3 months (Insulin Resistant Exercise Group vs Insulin Resistant Control Group). The Insulin Sensitive Lean Group was only for baseline comparisons.
Difference from baseline and 3 months of the insulin area on under the curve - A measure of insulin sensitivity as measured during an oral meal tolerance test - Time points (-20, 0, 10, 20, 30, 60, 90, 150, 240 minutes)
Outcome measures
| Measure |
Insulin Resistant Exercise Group
n=32 Participants
Resistance (RE) training will be performed 4 days per week using a combination of upper and lower body exercises at 8-12 repetitions per set. Resistance training will be performed using a combination of upper and lower body exercises using machine and free weights. Upper body exercises are chest press, incline press, seated row, lat pull down, triceps extension, biceps curl and lateral raises. Major muscle groups for upper body exercises will include chest (pectoralis major and minor), arm (biceps and triceps), shoulder (deltoids) and back (latissimus dorsi and rhomboids). Lower body exercises are leg press, lunge (with body weight progressing to dumbbells), seated leg extension, seated leg curl, calf raises and abdominal crunches. Major muscle groups for the lower body exercises will be thighs (quadriceps and hamstrings), calves (gastrocnemius and soleus) and core (rectus abdominus and obliques).
Resistance Exercise: Resistance (RE) training will be performed 4 days per week using a combination of upper and lower body exercises at 8-12 repetitions per set. Participants will complete 2 progressing to 4 sets of 8 to 12 repetitions per exercise, with 1 minute rest between sets. Participants will warmup for 5 minutes on a treadmill, cycle ergometer or elliptical at \~50% VO2 peak then begin resistance training. Participants will begin at 2 sets per exercise on weeks 1 and 2, then 3 sets for week 3, and 4 sets for weeks 4 to 12.
|
Insulin Resistant Control Group
n=15 Participants
Participants in this group will perform no exercise for the 3 month study period.
|
|---|---|---|
|
Change in Insulin Sensitivity
|
-743.7 μIU*min/mL
Standard Deviation 2292
|
-105.7 μIU*min/mL
Standard Deviation 2015
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: Only longitudinal arms were analyzed since this is a measure of change between baseline and 3 months (Insulin Resistant Exercise Group vs Insulin Resistant Control Group). The Insulin Sensitive Lean Group was only for baseline comparisons.
Change in body lean mass as measured by DEXA scan
Outcome measures
| Measure |
Insulin Resistant Exercise Group
n=32 Participants
Resistance (RE) training will be performed 4 days per week using a combination of upper and lower body exercises at 8-12 repetitions per set. Resistance training will be performed using a combination of upper and lower body exercises using machine and free weights. Upper body exercises are chest press, incline press, seated row, lat pull down, triceps extension, biceps curl and lateral raises. Major muscle groups for upper body exercises will include chest (pectoralis major and minor), arm (biceps and triceps), shoulder (deltoids) and back (latissimus dorsi and rhomboids). Lower body exercises are leg press, lunge (with body weight progressing to dumbbells), seated leg extension, seated leg curl, calf raises and abdominal crunches. Major muscle groups for the lower body exercises will be thighs (quadriceps and hamstrings), calves (gastrocnemius and soleus) and core (rectus abdominus and obliques).
Resistance Exercise: Resistance (RE) training will be performed 4 days per week using a combination of upper and lower body exercises at 8-12 repetitions per set. Participants will complete 2 progressing to 4 sets of 8 to 12 repetitions per exercise, with 1 minute rest between sets. Participants will warmup for 5 minutes on a treadmill, cycle ergometer or elliptical at \~50% VO2 peak then begin resistance training. Participants will begin at 2 sets per exercise on weeks 1 and 2, then 3 sets for week 3, and 4 sets for weeks 4 to 12.
|
Insulin Resistant Control Group
n=15 Participants
Participants in this group will perform no exercise for the 3 month study period.
|
|---|---|---|
|
Change in Lean Mass
|
542 grams
Standard Deviation 1526
|
-377 grams
Standard Deviation 1348
|
SECONDARY outcome
Timeframe: Baseline and 3 MonthsPopulation: Only longitudinal arms were analyzed since this is a measure of change between baseline and 3 months (Insulin Resistant Exercise Group vs Insulin Resistant Control Group). The Insulin Sensitive Lean Group was only for baseline comparisons.
Change in body fat percentage as measured by DEXA scan
Outcome measures
| Measure |
Insulin Resistant Exercise Group
n=32 Participants
Resistance (RE) training will be performed 4 days per week using a combination of upper and lower body exercises at 8-12 repetitions per set. Resistance training will be performed using a combination of upper and lower body exercises using machine and free weights. Upper body exercises are chest press, incline press, seated row, lat pull down, triceps extension, biceps curl and lateral raises. Major muscle groups for upper body exercises will include chest (pectoralis major and minor), arm (biceps and triceps), shoulder (deltoids) and back (latissimus dorsi and rhomboids). Lower body exercises are leg press, lunge (with body weight progressing to dumbbells), seated leg extension, seated leg curl, calf raises and abdominal crunches. Major muscle groups for the lower body exercises will be thighs (quadriceps and hamstrings), calves (gastrocnemius and soleus) and core (rectus abdominus and obliques).
Resistance Exercise: Resistance (RE) training will be performed 4 days per week using a combination of upper and lower body exercises at 8-12 repetitions per set. Participants will complete 2 progressing to 4 sets of 8 to 12 repetitions per exercise, with 1 minute rest between sets. Participants will warmup for 5 minutes on a treadmill, cycle ergometer or elliptical at \~50% VO2 peak then begin resistance training. Participants will begin at 2 sets per exercise on weeks 1 and 2, then 3 sets for week 3, and 4 sets for weeks 4 to 12.
|
Insulin Resistant Control Group
n=15 Participants
Participants in this group will perform no exercise for the 3 month study period.
|
|---|---|---|
|
Change in Fat Percentage
|
-0.89 Percentage
Standard Deviation 1.01
|
0.12 Percentage
Standard Deviation 1.14
|
Adverse Events
Insulin Resistant Exercise Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Insulin Resistant Control Group
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
Dr. Sreekumaran Nair - Principal Investigator
Mayo Clinic
Phone: 507-284-2511
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place