Exercise Regulation of Human Adipose Tissue

NCT03133156 | Completed Results

• 2 other identifiers: 2016-33R01DK112283
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Obese; Diabetes Mellitus, Type 2

Keywords

Exercise; Training; Type 2 Diabetes; Mellitus

Outcome Measures

Primary Outcomes (3)

• Changes in Human Adipose Tissue Characteristics Following 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

  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

  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.

Study Arms (4)

Moderate Intensity Training-Healthy Lean

EXPERIMENTAL

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

Other: Exercise Intervention

Moderate Intensity Training-Healthy Overweight/Obese

EXPERIMENTAL

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

Other: Exercise Intervention

Moderate Intensity Training-Overweight/Obese Type 2 Diabetes

EXPERIMENTAL

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

Other: Exercise Intervention

High Intensity Training-Healthy Lean.

EXPERIMENTAL

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

Other: Exercise Intervention

Interventions

Exercise Intervention OTHER

10-Week Aerobic Exercise Training

High Intensity Training-Healthy Lean.; Moderate Intensity Training-Healthy Lean; Moderate Intensity Training-Healthy Overweight/Obese; Moderate Intensity Training-Overweight/Obese Type 2 Diabetes

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• ± 0.1% - 9.0 ± 0.1% for subjects with type 2 diabetes

You may not qualify if:

• 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

Sponsors & Collaborators

• Joslin Diabetes Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Behavior

Results Point of Contact

• Title: Laura Simpson
• Organization: Joslin Diabetes Center

laura.simpson@joslin.harvard.edu

617-735-3924

Study Officials

• Laurie J Goodyear, PhD

  Joslin Diabetes Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The current research will consist of 2 different exercise training protocols. Subjects will be randomized into each Arm based on screening criteria and compared to the control (Arm 1)

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: April 28, 2017
• Study Start: June 15, 2017
• Primary Completion: January 17, 2024
• Study Completion: June 24, 2024
• Last Updated: August 14, 2025
• Results First Posted: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)