Exercise Regulation of Human Adipose Tissue

August 13, 2025 updated by: Joslin Diabetes Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Moderate Intensity Training-Healthy Lean
Eligible subjects will undergo a 10-week moderate intensity exercise program.
Other: Exercise Intervention
10-Week Aerobic Exercise Training
Experimental: Moderate Intensity Training-Healthy Overweight/Obese
Eligible subjects will undergo a 10-week moderate intensity exercise program.
Other: Exercise Intervention
10-Week Aerobic Exercise Training
Experimental: Moderate Intensity Training-Overweight/Obese Type 2 Diabetes
Eligible subjects will undergo a 10-week moderate intensity exercise program.
Other: Exercise Intervention
10-Week Aerobic Exercise Training
Experimental: High Intensity Training-Healthy Lean.
Eligible subjects will undergo a 10-week high intensity exercise program
Other: Exercise Intervention
10-Week Aerobic Exercise Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Human Adipose Tissue Characteristics Following Exercise Training
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
Baseline measurement (week 0, prior to starting exercise training) and post-intervention measurement at week 10, after completion of exercise training.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joslin Diabetes Center

Collaborators

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

Investigators

  • Principal Investigator: Laurie J Goodyear, PhD, Joslin Diabetes Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2017

Primary Completion (Actual)

January 17, 2024

Study Completion (Actual)

June 24, 2024

Study Registration Dates

First Submitted

February 22, 2017

First Submitted That Met QC Criteria

April 25, 2017

First Posted (Actual)

April 28, 2017

Study Record Updates

Last Update Posted (Actual)

August 14, 2025

Last Update Submitted That Met QC Criteria

August 13, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-33
  • R01DK112283 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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