Exercise Regulation of Human Adipose Tissue

NCT ID: NCT03133156

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-15
• Study Completion Date: 2024-06-24

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.

Conditions

Healthy; Obese; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Moderate Intensity Training-Healthy Lean

Eligible subjects will undergo a 10-week moderate intensity exercise program.

Group Type: EXPERIMENTAL

Exercise Intervention

Intervention Type: OTHER

10-Week Aerobic Exercise Training

Moderate Intensity Training-Healthy Overweight/Obese

Eligible subjects will undergo a 10-week moderate intensity exercise program.

Group Type: EXPERIMENTAL

Exercise Intervention

Intervention Type: OTHER

10-Week Aerobic Exercise Training

Moderate Intensity Training-Overweight/Obese Type 2 Diabetes

Eligible subjects will undergo a 10-week moderate intensity exercise program.

Group Type: EXPERIMENTAL

Exercise Intervention

Intervention Type: OTHER

10-Week Aerobic Exercise Training

High Intensity Training-Healthy Lean.

Eligible subjects will undergo a 10-week high intensity exercise program

Group Type: EXPERIMENTAL

Exercise Intervention

Intervention Type: OTHER

10-Week Aerobic Exercise Training

Interventions

Exercise Intervention

10-Week Aerobic Exercise Training

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Joslin Diabetes Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurie J Goodyear, PhD

Role: PRINCIPAL_INVESTIGATOR

Joslin Diabetes Center

Locations

Joslin Diabetes Center

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01DK112283

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2016-33

Identifier Type: -

Identifier Source: org_study_id