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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK112283 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate Intensity Training-Healthy Lean | Experimental | Eligible subjects will undergo a 10-week moderate intensity exercise program. |
|
| Moderate Intensity Training-Healthy Overweight/Obese | Experimental | Eligible subjects will undergo a 10-week moderate intensity exercise program. |
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| Moderate Intensity Training-Overweight/Obese Type 2 Diabetes | Experimental | Eligible subjects will undergo a 10-week moderate intensity exercise program. |
|
| High Intensity Training-Healthy Lean. | Experimental | Eligible subjects will undergo a 10-week high intensity exercise program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention | Other | 10-Week Aerobic Exercise Training |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Human Adipose Tissue Characteristics Following Exercise Training | Body fat percentage measured before and after exercise training with a bioelectrical impedance scale. | Baseline measurement (week 0, prior to starting exercise training) and post-intervention measurement at week 10, after completion of exercise training. |
| Changes in Human Adipose Tissue Characteristics Following Exercise Training | Body fat mass measured before and after exercise training with a bioelectrical impedance scale. | Baseline measurement (week 0, prior to starting exercise training) and post-intervention measurement at week 10, after completion of exercise training. |
| Changes in Human Adipose Tissue Characteristics Following Exercise Training | Body weight measured before and after exercise training with a bioelectrical impedance scale. | Baseline measurement (week 0, prior to starting exercise training) and post-intervention measurement at week 10, after completion of exercise training. |
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Inclusion Criteria:
Age: 25-55 years old at the time of screening
Body mass index (BMI) must be:
HbA1c values:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurie J Goodyear, PhD | Joslin Diabetes Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Moderate Intensity Training-Healthy Lean | Eligible subjects will undergo a 10-week moderate intensity exercise program. |
| FG001 | Moderate Intensity Training-Healthy Overweight/Obese | Eligible subjects will undergo a 10-week moderate intensity exercise program. |
| FG002 | Moderate Intensity Training-Overweight/Obese Type 2 Diabetes | Eligible subjects will undergo a 10-week moderate intensity exercise program. |
| FG003 | High Intensity Training-Healthy Lean | Eligible subjects will undergo a 10-week high intensity exercise program |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Groups included sedentary adults aged 25-55: lean, overweight/obese without T2DM, and overweight/obese with T2DM. Equal numbers of males and females were enrolled where possible. Participants who did not complete baseline assessments were excluded.
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| ID | Title | Description |
|---|---|---|
| BG000 | Moderate Intensity Training-Healthy Lean | Eligible subjects will undergo a 10-week moderate intensity exercise program. Exercise Intervention: 10-Week Aerobic Exercise Training |
| BG001 | Moderate Intensity Training-Healthy Overweight/Obese |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Human Adipose Tissue Characteristics Following Exercise Training | Body fat percentage measured before and after exercise training with a bioelectrical impedance scale. | Posted | Mean | Standard Deviation | body fat % | Baseline measurement (week 0, prior to starting exercise training) and post-intervention measurement at week 10, after completion of exercise training. |
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Moderate Intensity Training-Healthy Lean | Eligible subjects will undergo a 10-week moderate intensity exercise program. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Simpson | Joslin Diabetes Center | 617-735-3924 | laura.simpson@joslin.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 24, 2020 | Jul 28, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 21, 2023 | Jul 25, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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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)
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Eligible subjects will undergo a 10-week moderate intensity exercise program. Exercise Intervention: 10-Week Aerobic Exercise Training |
| BG002 | 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 |
| BG003 | High Intensity Training-Healthy Lean. | Eligible subjects will undergo a 10-week high intensity exercise program Exercise Intervention: 10-Week Aerobic Exercise Training |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Fat Percentage (via Bioelectrical Impedance Analysis | "Body fat percentage data unavailable due to recording error." | Mean | Standard Deviation | Body Fat % |
|
| Bodyweight | Mean | Standard Deviation | kilograms |
|
| Body Fat Mass | Body fat mass data unavailable due to a recording error. | Mean | Standard Deviation | kilograms |
|
| OG002 | Moderate Intensity Training-Overweight/Obese Type 2 Diabetes | Eligible subjects will undergo a 10-week moderate intensity exercise program. |
| OG003 | High Intensity Training-Healthy Lean | Eligible subjects will undergo a 10-week high intensity exercise program |
|
|
| Primary | Changes in Human Adipose Tissue Characteristics Following Exercise Training | Body fat mass measured before and after exercise training with a bioelectrical impedance scale. | Posted | Mean | Standard Deviation | kilograms | Baseline measurement (week 0, prior to starting exercise training) and post-intervention measurement at week 10, after completion of exercise training. |
|
|
|
| Primary | Changes in Human Adipose Tissue Characteristics Following Exercise Training | Body weight measured before and after exercise training with a bioelectrical impedance scale. | Posted | Mean | Standard Deviation | kilograms | Baseline measurement (week 0, prior to starting exercise training) and post-intervention measurement at week 10, after completion of exercise training. |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 2 |
| 35 |
| EG001 | Moderate Intensity Training-Healthy Overweight/Obese | Eligible subjects will undergo a 10-week moderate intensity exercise program. | 0 | 35 | 0 | 35 | 1 | 35 |
| EG002 | Moderate Intensity Training-Overweight/Obese Type 2 Diabetes | Eligible subjects will undergo a 10-week moderate intensity exercise program. | 0 | 11 | 0 | 11 | 1 | 11 |
| EG003 | High Intensity Training-Healthy Lean | Eligible subjects will undergo a 10-week high intensity exercise program | 0 | 12 | 0 | 12 | 1 | 12 |
| Knee Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Ankle Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscle Cramp | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Parethesia | Nervous system disorders | Non-systematic Assessment |
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| Chest Discomfort | Cardiac disorders | Non-systematic Assessment |
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| Lightheadedness | Nervous system disorders | Non-systematic Assessment |
|
| Toe Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| post-training |
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| post-training |
|