Exercise Regulation of Human Adipose Tissue

Joslin Diabetes Center

Status: Completed

Conditions: Obese; Healthy; Diabetes Mellitus, Type 2

Treatments: Other: Exercise Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03133156

R01DK112283 (U.S. NIH Grant/Contract)

2016-33

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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93 participants in 4 patient groups

Moderate Intensity Training-Healthy Lean

Experimental group

Description:

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

Treatment:

Other: Exercise Intervention

Moderate Intensity Training-Healthy Overweight/Obese

Experimental group

Description:

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

Treatment:

Other: Exercise Intervention

Moderate Intensity Training-Overweight/Obese Type 2 Diabetes

Experimental group

Description:

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

Treatment:

Other: Exercise Intervention

High Intensity Training-Healthy Lean.

Experimental group

Description:

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

Treatment:

Other: Exercise Intervention