Diabetes Mellitus, Type 2, Healthy, Obese
Conditions
Keywords
Exercise, Training, Type 2 Diabetes, Mellitus
Brief summary
The purpose of this study is to determine whether exercise training leads to changes in the white adipose tissue that are beneficial to the body's regulation of sugar and body weight.
Detailed description
The prevalence of obesity and type 2 diabetes in the United States and worldwide has risen dramatically over the last few decades, resulting in an enormous need for new therapies to treat these conditions. The discovery that beiging of subcutaneous white adipose tissue may increase energy expenditure has led to tremendous interest in beige cells as a potential treatment for diabetes and obesity. An established treatment for type 2 diabetes and obesity is endurance exercise training. Exercise training can improve systemic homeostasis, and although adaptations to skeletal muscle play a critical role in these effects, the underlying mechanisms are not fully understood. Moreover, the contributions of other tissues in these beneficial effects of exercise on metabolism have not been intensively investigated. The study team hypothesizes that exercise training results in fundamental changes to white adipose tissue, including beiging, and these adaptations play an important role in the effects of exercise training to improve metabolic homeostasis.
Interventions
OTHERExercise Intervention
10-Week Aerobic Exercise Training
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Joslin Diabetes Center
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
The current research will consist of 2 different exercise training protocols. Subjects will be randomized into each Arm based on screening criteria and compared to the control (Arm 1)
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Age: 25-55 years old at the time of screening * Body mass index (BMI) must be: * ≥20 and ≤ 27 kg/m2 for lean subjects * ≥25 and ≤ 37 kg/m2 for subjects with type 2 diabetes * ≥27 and ≤ 37 kg/m2 for obese/overweight subjects * HbA1c values: * ≤5.7 ± 0.1% for lean and overweight/obese subjects * 6.5 ± 0.1% - 9.0 ± 0.1% for subjects with type 2 diabetes
Exclusion criteria
* Age \<25 and \>55 years old * Type 1 Diabetes * HbA1c ≥ 9.0% * Heart or lung disease * Basal-Bolus Insulin regimen * Use of beta-blockers or thiazolidinediones * Acute systemic infection accompanied by fever, body aches, or swollen lymph glands * BMI ≥ 37 kg/m2 * Current dieting or weight loss efforts * Current pregnant or breastfeeding * Known history of HIV/AIDS or certain cancers * Biochemical evidence of renal or hepatic dysfunction; renal or liver disease * Demyelinating diseases such as multiple sclerosis or amyotrophic lateral sclerosis * Recent blood donation * Clinical history of stroke * Severe hypertension (systolic \> 160 mmHg or diastolic \> 90 mmHg) * Inability to exercise at 50% of predicted heart rate (HR) reserve at baseline * Participants who screen positive for The American Heart Association's contraindications to exercise testing * History of keloid formation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Human Adipose Tissue Characteristics Following Exercise Training | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Moderate Intensity Training-Healthy Lean Eligible subjects will undergo a 10-week moderate intensity exercise program.
Exercise Intervention: 10-Week Aerobic Exercise Training | 35 |
| Moderate Intensity Training-Healthy Overweight/Obese Eligible subjects will undergo a 10-week moderate intensity exercise program.
Exercise Intervention: 10-Week Aerobic Exercise Training | 35 |
| Moderate Intensity Training-Overweight/Obese Type 2 Diabetes Eligible subjects will undergo a 10-week moderate intensity exercise program.
Exercise Intervention: 10-Week Aerobic Exercise Training | 11 |
| High Intensity Training-Healthy Lean. Eligible subjects will undergo a 10-week high intensity exercise program
Exercise Intervention: 10-Week Aerobic Exercise Training | 12 |
| Total | 93 |
Baseline characteristics
| Characteristic | Total | High Intensity Training-Healthy Lean. | Moderate Intensity Training-Overweight/Obese Type 2 Diabetes | Moderate Intensity Training-Healthy Overweight/Obese | Moderate Intensity Training-Healthy Lean |
|---|---|---|---|---|---|
| Age, Continuous | 38.8 years STANDARD_DEVIATION 9 | 36.9 years STANDARD_DEVIATION 9.7 | 49.6 years STANDARD_DEVIATION 5.1 | 38.9 years STANDARD_DEVIATION 8.5 | 36 years STANDARD_DEVIATION 8 |
| Body Fat Mass | 24.4 kilograms STANDARD_DEVIATION 9.2 | 19.31 kilograms STANDARD_DEVIATION 5.38 | 32.01 kilograms STANDARD_DEVIATION 6.74 | 30.75 kilograms STANDARD_DEVIATION 7.94 | 24.49 kilograms STANDARD_DEVIATION 6.65 |
| Body Fat Percentage (via Bioelectrical Impedance Analysis | 30.44 Body Fat % STANDARD_DEVIATION 9 | 26.60 Body Fat % STANDARD_DEVIATION 7.71 | 38.42 Body Fat % STANDARD_DEVIATION 6.71 | 35.04 Body Fat % STANDARD_DEVIATION 7.69 | 24.49 Body Fat % STANDARD_DEVIATION 6.65 |
| Bodyweight | 78.8 kilograms STANDARD_DEVIATION 13 | 73.03 kilograms STANDARD_DEVIATION 11.19 | 83.01 kilograms STANDARD_DEVIATION 8.42 | 88.04 kilograms STANDARD_DEVIATION 11.89 | 70.21 kilograms STANDARD_DEVIATION 8.81 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 2 Participants | 0 Participants | 4 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 71 Participants | 6 Participants | 10 Participants | 27 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 11 Participants | 4 Participants | 1 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 20 Participants | 4 Participants | 1 Participants | 5 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 65 Participants | 8 Participants | 8 Participants | 28 Participants | 21 Participants |
| Region of Enrollment United States | 93 participants | 12 participants | 11 participants | 35 participants | 35 participants |
| Sex: Female, Male Female | 48 Participants | 6 Participants | 8 Participants | 19 Participants | 15 Participants |
| Sex: Female, Male Male | 45 Participants | 6 Participants | 3 Participants | 16 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 | 0 / 11 | 0 / 12 |
| other Total, other adverse events | 2 / 35 | 1 / 35 | 1 / 11 | 1 / 12 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 | 0 / 11 | 0 / 12 |
Outcome results
Primary
Changes in Human Adipose Tissue Characteristics Following Exercise Training
Body fat percentage measured before and after exercise training with a bioelectrical impedance scale.
Time frame: Baseline measurement (week 0, prior to starting exercise training) and post-intervention measurement at week 10, after completion of exercise training.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Moderate Intensity Training-Healthy Lean | Changes in Human Adipose Tissue Characteristics Following Exercise Training | pre-training | 25.45 body fat % | Standard Deviation 6.34 |
| Moderate Intensity Training-Healthy Lean | Changes in Human Adipose Tissue Characteristics Following Exercise Training | post-training | 25.38 body fat % | Standard Deviation 7.02 |
| Moderate Intensity Training-Healthy Overweight/Obese | Changes in Human Adipose Tissue Characteristics Following Exercise Training | post-training | 33.90 body fat % | Standard Deviation 8.6 |
| Moderate Intensity Training-Healthy Overweight/Obese | Changes in Human Adipose Tissue Characteristics Following Exercise Training | pre-training | 34.12 body fat % | Standard Deviation 7.97 |
| Moderate Intensity Training-Overweight/Obese Type 2 Diabetes | Changes in Human Adipose Tissue Characteristics Following Exercise Training | post-training | 37.20 body fat % | Standard Deviation 7.31 |
| Moderate Intensity Training-Overweight/Obese Type 2 Diabetes | Changes in Human Adipose Tissue Characteristics Following Exercise Training | pre-training | 38.06 body fat % | Standard Deviation 6.96 |
| High Intensity Training-Healthy Lean | Changes in Human Adipose Tissue Characteristics Following Exercise Training | pre-training | 27.05 body fat % | Standard Deviation 7.7 |
| High Intensity Training-Healthy Lean | Changes in Human Adipose Tissue Characteristics Following Exercise Training | post-training | 25.32 body fat % | Standard Deviation 7.57 |
Primary
Changes in Human Adipose Tissue Characteristics Following Exercise Training
Body fat mass measured before and after exercise training with a bioelectrical impedance scale.
Time frame: Baseline measurement (week 0, prior to starting exercise training) and post-intervention measurement at week 10, after completion of exercise training.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Moderate Intensity Training-Healthy Lean | Changes in Human Adipose Tissue Characteristics Following Exercise Training | pre-training | 17.83 kilograms | Standard Deviation 4.38 |
| Moderate Intensity Training-Healthy Lean | Changes in Human Adipose Tissue Characteristics Following Exercise Training | post-training | 17.69 kilograms | Standard Deviation 4.72 |
| Moderate Intensity Training-Healthy Overweight/Obese | Changes in Human Adipose Tissue Characteristics Following Exercise Training | post-training | 29.61 kilograms | Standard Deviation 8.22 |
| Moderate Intensity Training-Healthy Overweight/Obese | Changes in Human Adipose Tissue Characteristics Following Exercise Training | pre-training | 29.96 kilograms | Standard Deviation 7.55 |
| Moderate Intensity Training-Overweight/Obese Type 2 Diabetes | Changes in Human Adipose Tissue Characteristics Following Exercise Training | pre-training | 31.47 kilograms | Standard Deviation 6.85 |
| Moderate Intensity Training-Overweight/Obese Type 2 Diabetes | Changes in Human Adipose Tissue Characteristics Following Exercise Training | post-training | 30.61 kilograms | Standard Deviation 7.23 |
| High Intensity Training-Healthy Lean | Changes in Human Adipose Tissue Characteristics Following Exercise Training | pre-training | 19.76 kilograms | Standard Deviation 5.54 |
| High Intensity Training-Healthy Lean | Changes in Human Adipose Tissue Characteristics Following Exercise Training | post-training | 18.11 kilograms | Standard Deviation 5.81 |
Primary
Changes in Human Adipose Tissue Characteristics Following Exercise Training
Body weight measured before and after exercise training with a bioelectrical impedance scale.
Time frame: Baseline measurement (week 0, prior to starting exercise training) and post-intervention measurement at week 10, after completion of exercise training.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Moderate Intensity Training-Healthy Lean | Changes in Human Adipose Tissue Characteristics Following Exercise Training | pre-training | 70.55 kilograms | Standard Deviation 8.99 |
| Moderate Intensity Training-Healthy Lean | Changes in Human Adipose Tissue Characteristics Following Exercise Training | post-training | 70.4 kilograms | Standard Deviation 8.67 |
| Moderate Intensity Training-Healthy Overweight/Obese | Changes in Human Adipose Tissue Characteristics Following Exercise Training | post-training | 87.59 kilograms | Standard Deviation 10.8 |
| Moderate Intensity Training-Healthy Overweight/Obese | Changes in Human Adipose Tissue Characteristics Following Exercise Training | pre-training | 88.22 kilograms | Standard Deviation 10.47 |
| Moderate Intensity Training-Overweight/Obese Type 2 Diabetes | Changes in Human Adipose Tissue Characteristics Following Exercise Training | pre-training | 82.4 kilograms | Standard Deviation 8.62 |
| Moderate Intensity Training-Overweight/Obese Type 2 Diabetes | Changes in Human Adipose Tissue Characteristics Following Exercise Training | post-training | 81.90 kilograms | Standard Deviation 8.97 |
| High Intensity Training-Healthy Lean | Changes in Human Adipose Tissue Characteristics Following Exercise Training | pre-training | 73.27 kilograms | Standard Deviation 12.07 |
| High Intensity Training-Healthy Lean | Changes in Human Adipose Tissue Characteristics Following Exercise Training | post-training | 71.81 kilograms | Standard Deviation 12.78 |