Exercise for Metabolic Disorders

(Columbus Trial)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Translational Research Institute for Metabolism and Diabetes, Florida

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The purpose of this study is to collect data to help researchers identify factors, such as certain proteins or genetic codes, that are secreted from muscle that are associated with the beneficial effects of exercise.

Research Team

Steven R Smith, MD

Principal Investigator

Translational Research Institute for Metabolism and Diabetes

Eligibility Criteria

This trial is for healthy men and women aged 18-40 who don't have Type 2 Diabetes or significant diseases affecting the kidneys, heart, liver, lungs, or nerves. Participants must not use certain weight-affecting drugs and should be free from recent surgeries or conditions that affect blood flow. They can't smoke or consume alcohol/caffeine before tests.

Inclusion Criteria

I am between 18 and 40 years old and in good health.

Willing to stop alcohol and caffeine consumption for 48 hours preceding each blood draw

Exclusion Criteria

Abnormal resting ECG

Unwilling or unable to abstain from caffeine or alcohol 48 hours prior to metabolic rate measurements

Metal objects that would interfere with the measurement of body composition /magnetic resonance spectroscopy such as implanted rods, surgical clips, etc

Treatment Details

Interventions

• Exercise (Behavioral Intervention)

Trial Overview The study aims to identify muscle-secreted factors that contribute to exercise's benefits by analyzing participants' responses to physical activity. Researchers will look for proteins and genetic markers linked with improved lipid oxidation.

Participant Groups

Group I: Group 1 - Regular exercise Experimental Treatment 1 Intervention

Alternate interval training and aerobic training and exercise

Group II: Group 2 - Athlete exercise Active Control 1 Intervention

Athletes are not given any intervention

Group III: Group 3 - Obese No Exercise Active Control 1 Intervention

The Obese group will not receive intervention

Who Is Running the Clinical Trial?

Translational Research Institute for Metabolism and Diabetes, Florida

Lead Sponsor

Trials

41

Recruited

3,600+

AdventHealth Translational Research Institute

Lead Sponsor

Trials

51

Recruited

5,900+

Sanford-Burnham Medical Research Institute

Collaborator

Trials

9

Recruited

770+

Takeda

Industry Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier