Trial Outcomes & Findings for Exercise Regulation of Human Adipose Tissue (NCT NCT03133156)
NCT ID: NCT03133156
Last Updated: 2025-08-14
Results Overview
Body fat percentage measured before and after exercise training with a bioelectrical impedance scale.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
93 participants
Primary outcome timeframe
Baseline measurement (week 0, prior to starting exercise training) and post-intervention measurement at week 10, after completion of exercise training.
Results posted on
2025-08-14
Participant Flow
Participant milestones
| Measure |
Moderate Intensity Training-Healthy Lean
Eligible subjects will undergo a 10-week moderate intensity exercise program.
|
Moderate Intensity Training-Healthy Overweight/Obese
Eligible subjects will undergo a 10-week moderate intensity exercise program.
|
Moderate Intensity Training-Overweight/Obese Type 2 Diabetes
Eligible subjects will undergo a 10-week moderate intensity exercise program.
|
High Intensity Training-Healthy Lean
Eligible subjects will undergo a 10-week high intensity exercise program
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
11
|
12
|
|
Overall Study
COMPLETED
|
26
|
28
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
"Body fat percentage data unavailable due to recording error."
Baseline characteristics by cohort
| Measure |
Moderate Intensity Training-Healthy Lean
n=35 Participants
Eligible subjects will undergo a 10-week moderate intensity exercise program.
Exercise Intervention: 10-Week Aerobic Exercise Training
|
Moderate Intensity Training-Healthy Overweight/Obese
n=35 Participants
Eligible subjects will undergo a 10-week moderate intensity exercise program.
Exercise Intervention: 10-Week Aerobic Exercise Training
|
Moderate Intensity Training-Overweight/Obese Type 2 Diabetes
n=11 Participants
Eligible subjects will undergo a 10-week moderate intensity exercise program.
Exercise Intervention: 10-Week Aerobic Exercise Training
|
High Intensity Training-Healthy Lean.
n=12 Participants
Eligible subjects will undergo a 10-week high intensity exercise program
Exercise Intervention: 10-Week Aerobic Exercise Training
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
36 years
STANDARD_DEVIATION 8 • n=35 Participants
|
38.9 years
STANDARD_DEVIATION 8.5 • n=35 Participants
|
49.6 years
STANDARD_DEVIATION 5.1 • n=11 Participants
|
36.9 years
STANDARD_DEVIATION 9.7 • n=12 Participants
|
38.8 years
STANDARD_DEVIATION 9 • n=93 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=35 Participants
|
19 Participants
n=35 Participants
|
8 Participants
n=11 Participants
|
6 Participants
n=12 Participants
|
48 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=35 Participants
|
16 Participants
n=35 Participants
|
3 Participants
n=11 Participants
|
6 Participants
n=12 Participants
|
45 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=35 Participants
|
4 Participants
n=35 Participants
|
0 Participants
n=11 Participants
|
2 Participants
n=12 Participants
|
11 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=35 Participants
|
27 Participants
n=35 Participants
|
10 Participants
n=11 Participants
|
6 Participants
n=12 Participants
|
71 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=35 Participants
|
4 Participants
n=35 Participants
|
1 Participants
n=11 Participants
|
4 Participants
n=12 Participants
|
11 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=35 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=35 Participants
|
5 Participants
n=35 Participants
|
1 Participants
n=11 Participants
|
4 Participants
n=12 Participants
|
20 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=35 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=35 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=35 Participants
|
28 Participants
n=35 Participants
|
8 Participants
n=11 Participants
|
8 Participants
n=12 Participants
|
65 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=35 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=35 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
4 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=35 Participants
|
35 participants
n=35 Participants
|
11 participants
n=11 Participants
|
12 participants
n=12 Participants
|
93 participants
n=93 Participants
|
|
Body Fat Percentage (via Bioelectrical Impedance Analysis
|
24.49 Body Fat %
STANDARD_DEVIATION 6.65 • n=34 Participants • "Body fat percentage data unavailable due to recording error."
|
35.04 Body Fat %
STANDARD_DEVIATION 7.69 • n=35 Participants • "Body fat percentage data unavailable due to recording error."
|
38.42 Body Fat %
STANDARD_DEVIATION 6.71 • n=11 Participants • "Body fat percentage data unavailable due to recording error."
|
26.60 Body Fat %
STANDARD_DEVIATION 7.71 • n=12 Participants • "Body fat percentage data unavailable due to recording error."
|
30.44 Body Fat %
STANDARD_DEVIATION 9 • n=92 Participants • "Body fat percentage data unavailable due to recording error."
|
|
Bodyweight
|
70.21 kilograms
STANDARD_DEVIATION 8.81 • n=35 Participants
|
88.04 kilograms
STANDARD_DEVIATION 11.89 • n=35 Participants
|
83.01 kilograms
STANDARD_DEVIATION 8.42 • n=11 Participants
|
73.03 kilograms
STANDARD_DEVIATION 11.19 • n=12 Participants
|
78.8 kilograms
STANDARD_DEVIATION 13 • n=93 Participants
|
|
Body Fat Mass
|
24.49 kilograms
STANDARD_DEVIATION 6.65 • n=34 Participants • Body fat mass data unavailable due to a recording error.
|
30.75 kilograms
STANDARD_DEVIATION 7.94 • n=35 Participants • Body fat mass data unavailable due to a recording error.
|
32.01 kilograms
STANDARD_DEVIATION 6.74 • n=11 Participants • Body fat mass data unavailable due to a recording error.
|
19.31 kilograms
STANDARD_DEVIATION 5.38 • n=12 Participants • Body fat mass data unavailable due to a recording error.
|
24.4 kilograms
STANDARD_DEVIATION 9.2 • n=92 Participants • Body fat mass data unavailable due to a recording error.
|
PRIMARY outcome
Timeframe: Baseline measurement (week 0, prior to starting exercise training) and post-intervention measurement at week 10, after completion of exercise training.Body fat percentage measured before and after exercise training with a bioelectrical impedance scale.
Outcome measures
| Measure |
Moderate Intensity Training-Healthy Lean
n=26 Participants
Eligible subjects will undergo a 10-week moderate intensity exercise program.
|
Moderate Intensity Training-Healthy Overweight/Obese
n=28 Participants
Eligible subjects will undergo a 10-week moderate intensity exercise program.
|
Moderate Intensity Training-Overweight/Obese Type 2 Diabetes
n=10 Participants
Eligible subjects will undergo a 10-week moderate intensity exercise program.
|
High Intensity Training-Healthy Lean
n=10 Participants
Eligible subjects will undergo a 10-week high intensity exercise program
|
|---|---|---|---|---|
|
Changes in Human Adipose Tissue Characteristics Following Exercise Training
pre-training
|
25.45 body fat %
Standard Deviation 6.34
|
34.12 body fat %
Standard Deviation 7.97
|
38.06 body fat %
Standard Deviation 6.96
|
27.05 body fat %
Standard Deviation 7.70
|
|
Changes in Human Adipose Tissue Characteristics Following Exercise Training
post-training
|
25.38 body fat %
Standard Deviation 7.02
|
33.90 body fat %
Standard Deviation 8.60
|
37.20 body fat %
Standard Deviation 7.31
|
25.32 body fat %
Standard Deviation 7.57
|
PRIMARY outcome
Timeframe: Baseline measurement (week 0, prior to starting exercise training) and post-intervention measurement at week 10, after completion of exercise training.Body fat mass measured before and after exercise training with a bioelectrical impedance scale.
Outcome measures
| Measure |
Moderate Intensity Training-Healthy Lean
n=26 Participants
Eligible subjects will undergo a 10-week moderate intensity exercise program.
|
Moderate Intensity Training-Healthy Overweight/Obese
n=28 Participants
Eligible subjects will undergo a 10-week moderate intensity exercise program.
|
Moderate Intensity Training-Overweight/Obese Type 2 Diabetes
n=10 Participants
Eligible subjects will undergo a 10-week moderate intensity exercise program.
|
High Intensity Training-Healthy Lean
n=10 Participants
Eligible subjects will undergo a 10-week high intensity exercise program
|
|---|---|---|---|---|
|
Changes in Human Adipose Tissue Characteristics Following Exercise Training
pre-training
|
17.83 kilograms
Standard Deviation 4.38
|
29.96 kilograms
Standard Deviation 7.55
|
31.47 kilograms
Standard Deviation 6.85
|
19.76 kilograms
Standard Deviation 5.54
|
|
Changes in Human Adipose Tissue Characteristics Following Exercise Training
post-training
|
17.69 kilograms
Standard Deviation 4.72
|
29.61 kilograms
Standard Deviation 8.22
|
30.61 kilograms
Standard Deviation 7.23
|
18.11 kilograms
Standard Deviation 5.81
|
PRIMARY outcome
Timeframe: Baseline measurement (week 0, prior to starting exercise training) and post-intervention measurement at week 10, after completion of exercise training.Body weight measured before and after exercise training with a bioelectrical impedance scale.
Outcome measures
| Measure |
Moderate Intensity Training-Healthy Lean
n=26 Participants
Eligible subjects will undergo a 10-week moderate intensity exercise program.
|
Moderate Intensity Training-Healthy Overweight/Obese
n=28 Participants
Eligible subjects will undergo a 10-week moderate intensity exercise program.
|
Moderate Intensity Training-Overweight/Obese Type 2 Diabetes
n=10 Participants
Eligible subjects will undergo a 10-week moderate intensity exercise program.
|
High Intensity Training-Healthy Lean
n=10 Participants
Eligible subjects will undergo a 10-week high intensity exercise program
|
|---|---|---|---|---|
|
Changes in Human Adipose Tissue Characteristics Following Exercise Training
pre-training
|
70.55 kilograms
Standard Deviation 8.99
|
88.22 kilograms
Standard Deviation 10.47
|
82.4 kilograms
Standard Deviation 8.62
|
73.27 kilograms
Standard Deviation 12.07
|
|
Changes in Human Adipose Tissue Characteristics Following Exercise Training
post-training
|
70.4 kilograms
Standard Deviation 8.67
|
87.59 kilograms
Standard Deviation 10.8
|
81.90 kilograms
Standard Deviation 8.97
|
71.81 kilograms
Standard Deviation 12.78
|
Adverse Events
Moderate Intensity Training-Healthy Lean
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Moderate Intensity Training-Healthy Overweight/Obese
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Moderate Intensity Training-Overweight/Obese Type 2 Diabetes
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
High Intensity Training-Healthy Lean
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 |
Moderate Intensity Training-Healthy Lean
n=35 participants at risk
Eligible subjects will undergo a 10-week moderate intensity exercise program.
|
Moderate Intensity Training-Healthy Overweight/Obese
n=35 participants at risk
Eligible subjects will undergo a 10-week moderate intensity exercise program.
|
Moderate Intensity Training-Overweight/Obese Type 2 Diabetes
n=11 participants at risk
Eligible subjects will undergo a 10-week moderate intensity exercise program.
|
High Intensity Training-Healthy Lean
n=12 participants at risk
Eligible subjects will undergo a 10-week high intensity exercise program
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.9%
1/35 • 16 weeks
|
0.00%
0/35 • 16 weeks
|
0.00%
0/11 • 16 weeks
|
8.3%
1/12 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
2.9%
1/35 • 16 weeks
|
0.00%
0/35 • 16 weeks
|
0.00%
0/11 • 16 weeks
|
0.00%
0/12 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Ankle Pain
|
2.9%
1/35 • 16 weeks
|
0.00%
0/35 • 16 weeks
|
0.00%
0/11 • 16 weeks
|
0.00%
0/12 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramp
|
0.00%
0/35 • 16 weeks
|
0.00%
0/35 • 16 weeks
|
9.1%
1/11 • 16 weeks
|
0.00%
0/12 • 16 weeks
|
|
Nervous system disorders
Parethesia
|
0.00%
0/35 • 16 weeks
|
2.9%
1/35 • 16 weeks
|
0.00%
0/11 • 16 weeks
|
0.00%
0/12 • 16 weeks
|
|
Cardiac disorders
Chest Discomfort
|
2.9%
1/35 • 16 weeks
|
0.00%
0/35 • 16 weeks
|
0.00%
0/11 • 16 weeks
|
0.00%
0/12 • 16 weeks
|
|
Nervous system disorders
Lightheadedness
|
0.00%
0/35 • 16 weeks
|
0.00%
0/35 • 16 weeks
|
9.1%
1/11 • 16 weeks
|
0.00%
0/12 • 16 weeks
|
|
Injury, poisoning and procedural complications
Toe Injury
|
0.00%
0/35 • 16 weeks
|
2.9%
1/35 • 16 weeks
|
0.00%
0/11 • 16 weeks
|
0.00%
0/12 • 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place