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Exercise Regulation of Human Adipose Tissue

Primary Purpose

Healthy, Obese, Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Intervention
Sponsored by
Joslin Diabetes Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy focused on measuring Exercise, Training, Type 2 Diabetes, Mellitus

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Joslin Diabetes CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Moderate Intensity Training-Healthy Lean

Moderate Intensity Training-Healthy Overweight/Obese

Moderate Intensity Training-Overweight/Obese Type 2 Diabetes

High Intensity Training-Healthy Lean.

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Changes in human adipose tissue characteristics following exercise training.
Effects of exercise training on adipose tissue in humans.

Secondary Outcome Measures

Full Information

First Posted
February 22, 2017
Last Updated
January 4, 2023
Sponsor
Joslin Diabetes Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03133156
Brief Title
Exercise Regulation of Human Adipose Tissue
Official Title
Exercise Regulation of Human Adipose Tissue
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Joslin Diabetes Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Obese, Diabetes Mellitus, Type 2
Keywords
Exercise, Training, Type 2 Diabetes, Mellitus

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
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)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Moderate Intensity Training-Healthy Lean
Arm Type
Experimental
Arm Description
Eligible subjects will undergo a 10-week moderate intensity exercise program.
Arm Title
Moderate Intensity Training-Healthy Overweight/Obese
Arm Type
Experimental
Arm Description
Eligible subjects will undergo a 10-week moderate intensity exercise program.
Arm Title
Moderate Intensity Training-Overweight/Obese Type 2 Diabetes
Arm Type
Experimental
Arm Description
Eligible subjects will undergo a 10-week moderate intensity exercise program.
Arm Title
High Intensity Training-Healthy Lean.
Arm Type
Experimental
Arm Description
Eligible subjects will undergo a 10-week high intensity exercise program
Intervention Type
Other
Intervention Name(s)
Exercise Intervention
Intervention Description
10-Week Aerobic Exercise Training
Primary Outcome Measure Information:
Title
Changes in human adipose tissue characteristics following exercise training.
Description
Effects of exercise training on adipose tissue in humans.
Time Frame
Change from baseline adipose tissue characteristics following 10 weeks of exercise training.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Simpson
Phone
6173094378
Email
exercise.research@joslin.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurie J Goodyear, PhD
Organizational Affiliation
Joslin Diabetes Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joslin Diabetes Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Simpson
Phone
617-309-4378
Email
exercise.research@joslin.harvard.edu
First Name & Middle Initial & Last Name & Degree
Laurie J Goodyear, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Exercise Regulation of Human Adipose Tissue

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