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Completed

NCT Number: NCT03133156

Exercise Regulation of Human Adipose Tissue

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.

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Key information

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise intervention

Other

10-Week Aerobic Exercise Training

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Joslin Diabetes Center

Other

Collaborators

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

Registry information

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Apr 28, 2017
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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