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Exercise for Metabolic Disorders (Columbus Trial)

N/A

Waitlist Available

Led By Steven R Smith, MD

Research Sponsored by Translational Research Institute for Metabolism and Diabetes, Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Must not have

History of deep vein thrombosis or pulmonary embolism

Abnormal blood count/Anemia, or blood donation within the last 2 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (day -6), day 0, day 5, day 12, day 18

Awards & highlights

Summary

This trial will help researchers understand how different proteins and genetic codes affect muscles after exercise.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention in this trial is exercise, side effects might include typical post-exercise symptoms such as muscle soreness, fatigue, and increased heart rate during activity.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a deep vein thrombosis or pulmonary embolism.

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I have anemia or have donated blood in the last 2 months.

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I have not had major surgery on my abdomen, pelvis, or legs in the last 3 months.

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I have been diagnosed with a blood vessel problem in my legs.

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I have been diagnosed with Type 2 Diabetes.

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I have been pregnant or nursed a child in the last year.

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I have been diagnosed with congestive heart failure.

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I have severe varicose veins.

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I have cancer and may or may not be on chemotherapy.

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I have a genetic condition that affects blood clotting.

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I have nerve damage in my hands or feet.

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My family has a history of blood clots in the veins or lungs.

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I am on blood thinners or anti-platelet medications that can't be stopped for tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day -6), day 0, day 5, day 12, day 18

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (day -6), day 0, day 5, day 12, day 18

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day -6), day 0, day 5, day 12, day 18 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measure change in mitochondrial capacity

Secondary study objectives

Measure change in mRNA/miRNA levels

Measure change of expression of proteins

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Group 1 - Regular exerciseExperimental Treatment1 Intervention

Alternate interval training and aerobic training and exercise

Group II: Group 2 - Athlete exerciseActive Control1 Intervention

Athletes are not given any intervention

Group III: Group 3 - Obese No ExerciseActive Control1 Intervention

The Obese group will not receive intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise

2016

Completed Phase 1

~820

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

Translational Research Institute for Metabolism and Diabetes, FloridaLead Sponsor

40 Previous Clinical Trials

3,565 Total Patients Enrolled

AdventHealth Translational Research InstituteLead Sponsor

48 Previous Clinical Trials

5,572 Total Patients Enrolled

Sanford-Burnham Medical Research InstituteOTHER

8 Previous Clinical Trials

565 Total Patients Enrolled

Media Library

Exercise Clinical Trial Eligibility Overview. Trial Name: NCT01911091 — N/A

Lipid Disorders Research Study Groups: Group 1 - Regular exercise, Group 2 - Athlete exercise, Group 3 - Obese No Exercise

Lipid Disorders Clinical Trial 2023: Exercise Highlights & Side Effects. Trial Name: NCT01911091 — N/A

Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT01911091 — N/A

~5 spots leftby Sep 2025

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