Exercise Regulation of Human Adipose Tissue

Healthy Clinical Trial

Official title:

Exercise Regulation of Human Adipose Tissue

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03133156
• Other study ID #: 2016-33
• Secondary ID: R01DK112283
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 15, 2017
• Est. completion date: January 1, 2026

Study information

• Verified date: January 2024
• Source: Joslin Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 74
• Est. completion date: January 1, 2026
• Est. primary completion date: January 17, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Healthy
• Obese

Intervention

Other:
• Exercise Intervention
10-Week Aerobic Exercise Training

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Joslin Diabetes Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in human adipose tissue characteristics following exercise training.	Effects of exercise training on adipose tissue in humans.	Change from baseline adipose tissue characteristics following 10 weeks of exercise training.