Exercise Resistance in Type 2 Diabetes (RESIST)

February 5, 2024 updated by: AdventHealth Translational Research Institute

Investigating the Underlying Mechanisms of Exercise Resistance in Individuals With Type 2 Diabetes

The purpose of this study is to collect data to help researchers identify factors that prevent certain individuals from receiving the beneficial effects of exercise.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

STUDY OBJECTIVES/ENDPOINTS

  1. The primary endpoint of the study is the maximal capacity for mitochondrial ATP synthesis measured using 31P magnetic resonance spectroscopy (MRS).
  2. The principal secondary endpoint is the relationship between exercise-induced changes in mitochondrial function in vivo and exercise mimetic-induced changes in mitochondrial function in vitro.
  3. The principal tertiary endpoint is the relationship between the basal promoter methylation status of key genes involved in fuel metabolism and known to be activated by exercise in skeletal muscle tissue and cells and the exercise-induced response in mitochondrial function.

As exercise has an array of metabolic effects, and we are well positioned with our cutting-edge methodologies here at the Translational Research Institute (TRI), we will also measure whole body insulin sensitivity and metabolic flexibility by hyperinsulinemic-euglycemic clamp, substrate oxidation and energy expenditure in the whole room calorimeter/metabolic chamber and intramyocellular lipid content.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • Translational Research Institute for Metabolism and Diabetes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Type 2 Diabetes Inclusion Criteria (Group 1)

  • Age 30 to 65 years.
  • Male and Female
  • Type 2 diabetes determined by self-report or by a fasting glucose > 126mg/dl
  • POCT HbA1c result is 5.7-8.8% or for those on anti-diabetic medications, POCT HbA1c < 8.9% (no lower limit defined to account for those who illustrate tight glycemic control due to anti-diabetic medications).
  • HbA1c between 6.0% and 8.5% or for those on anti-diabetic medications, HbA1c ≤ 8.5% (no lower limit defined to account for those who illustrate tight glycemic control due to anti-diabetic medications). If a participant misses the screening HbA1c by a small margin (HbA1c ± 0.1%), the HbA1c can be repeated once.
  • Not involved in regular exercise program
  • Willing to exercise every day for the study period
  • If applicable, those currently taking anti-diabetic medication are taking metformin, a sulfonylurea, DPP IV inhibitor, alpha-glucosidase inhibitor, a meglitinide, colesevelam, cycloset or a SGLT2 inhibitor. Those taking 2 of these medications may proceed.
  • If applicable, willing to cease anti-diabetic medication use for the duration of the intervention.
  • BMI ≥ 22 kg/m2

Young Athletes Inclusion Criteria (Group 2)

  • Age 18 to 50 years
  • Male and Female
  • Engaged in a minimum of 4 cumulative hours of moderate to vigorous intensity aerobic exercise, over a minimum of 3 days per week.
  • BMI between 18 and 29.9 kg/m2
  • VO2max > 45 ml/min/kg BW

Non-diabetes Inclusion Criteria (Group 3)

  • Age 30 to 65 years
  • Male and Female
  • Not involved in a regular exercise program
  • Willing to exercise every day for the study period
  • BMI ≥ 22 kg/m2

General Exclusion Criteria A=all groups, Ex=exercise group only, ND=Non-diabetes group only

  • Resting blood pressure ≥ 160/100 mm Hg (A)
  • Triglycerides > 500 mg/dL (A)
  • HbA1c ≥ 6.5% (ND)
  • Previous or current use of an insulin pump or multiple insulin injections per day or any diabetes medications that the participant cannot refrain from for the duration of the study. (A)
  • Treatment with thiazolidinediones (TZDs) or GLP-1 agonists within the last 3 months. (A)
  • Unable or unwilling to communicate with staff or to provide written informed consent. (A)
  • Failure to complete baseline testing. (A)
  • Not physically capable of performing the exercise required of the study protocols. (Ex)
  • Consuming >14 alcoholic beverages per week. (A)
  • Plans to be away >2 weeks in the next 3 months. (A)
  • Lack of support from primary health care provider and/or family members.(Ex)
  • Significant weight loss in the past year (>20 lbs) or current use of weight loss medications. (A)
  • Bariatric surgery or planning bariatric surgery in the next 6 months.(Ex)
  • Presence of clinically significant abnormalities on ECG (A)
  • Any renal, cardiac, liver, lung, or neurological disease that in the opinion of the Investigator would compromise participant safety (A)
  • Use of drugs known to affect energy metabolism or body weight: including, but not limited to: orlistat, sibutramine, ephedrine, phenylpropanolamine, corticosterone, etc (A)
  • Current treatment with blood thinners or anti-platelet medications that cannot be safely stopped for testing procedures. (A)
  • New onset (<3 months on a stable regime) hormone replacement therapy. (A)
  • Current use of beta-adrenergic blocking agents (A)
  • Alcohol or other drug abuse (A)
  • Current smokers (smoking within the past 3 months) (A)
  • Gait problems (Ex)
  • Unwilling or unable to abstain from caffeine, alcohol or strenuous exercise (48h) prior to metabolic rate measurements (A)
  • Increased liver function tests (AST/ALT/GGT/or alkaline phosphatase greater than 2.5 times the upper limit of normal) (A)
  • Metal objects that would interfere with the measurement of body composition /MRS such as implanted rods, surgical clips, etc (A)
  • Any NYHA class of CHF (A)
  • Abnormal blood count/Anemia, blood transfusion or blood donation within the last 2 months. (A)
  • Major surgery on the abdomen, pelvis, or lower extremities within previous 3 months (A)
  • Bariatric surgery or liposuction within the previous 3 years (Ex)
  • Cancer (active malignancy with or without concurrent chemotherapy) (A)
  • Rheumatoid disease (A)
  • Bypass graft in limb (A)
  • Known genetic factor (Factor V Leiden, etc) or hypercoagulable state (A)
  • Peripheral neuropathy, involving more than the toes (A)
  • Claustrophobia (A)
  • Major Depression (Ex)
  • Presence of an eating disorder or eating attitudes/behaviors that could interfere with the study completion (Ex)
  • Females that are currently or have been pregnant or are currently or have nursed a child within the last 12 months (A)
  • Presence of any condition that, in the opinion of the investigator, compromises participant safety or data integrity or the participants' ability to complete the training protocol (Ex).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise
10 weeks of aerobic exercise
Behavioral: Exercise
10 weeks of aerobic exercise
No Intervention: Active Control
Young athletes as a trained control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ATPmax
Time Frame: Baseline and 10 weeks
The primary endpoint of the study is the maximal capacity for mitochondrial ATP synthesis (ATPmax) measured using 31P magnetic resonance spectroscopy (MRS).
Baseline and 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in in vivo and in vitro mitochondrial function
Time Frame: Baseline and 10 weeks
The principal secondary endpoint is the relationship between exercise-induced changes in mitochondrial function (ATPmax) in vivo and exercise mimetic-induced changes in mitochondrial function in vitro (maximal oxygen consumption of the human primary myotubes by the Oroboros® oxygraph).
Baseline and 10 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Promoter methylation
Time Frame: Baseline
The principal tertiary endpoint is the relationship between the basal promoter methylation status of key genes involved in fuel metabolism and known to be activated by exercise in skeletal muscle tissue and cells and the exercise-induced response in ATPmax.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth Translational Research Institute

Collaborators

American Diabetes Association

Investigators

  • Principal Investigator: Lauren M Sparks, PhD, Translational Research Institute for Metabolism and Diabetes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2013

Primary Completion (Actual)

January 1, 2017

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

July 23, 2013

First Submitted That Met QC Criteria

July 25, 2013

First Posted (Estimated)

July 30, 2013

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRIMDFH 471035
  • 471035 (Other Identifier: Florida Hospital IRB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes

Clinical Trials on Exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe