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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
Healthy men and women, aged 18 - 40, inclusive.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day -6), day 0, day 5, day 12, day 18
Awards & highlights
Columbus Trial 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.Check my eligibility
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.See study design
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.
Columbus Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 40 years old and in good health.
Columbus Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measure change in mitochondrial capacity
Secondary outcome measures
Measure change in mRNA/miRNA levels
Measure change of expression of proteins
Columbus 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
~760
Find a Location
Who is running the clinical trial?
Translational Research Institute for Metabolism and Diabetes, FloridaLead Sponsor
40 Previous Clinical Trials
3,541 Total Patients Enrolled
AdventHealth Translational Research InstituteLead Sponsor
48 Previous Clinical Trials
20,125 Total Patients Enrolled
Sanford-Burnham Medical Research InstituteOTHER
8 Previous Clinical Trials
365 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been pregnant or nursed a child in the last year.I have anemia or have donated blood in the last 2 months.I started using oral contraceptives or hormone therapy less than 3 months ago.I have been diagnosed with a blood vessel problem in my legs.I am not taking medications that affect my energy or weight.I have had a deep vein thrombosis or pulmonary embolism.I have not had major surgery on my abdomen, pelvis, or legs in the last 3 months.I do not have major heart, kidney, liver, lung, or brain diseases, but controlled high blood pressure is okay.I have been diagnosed with congestive heart failure.I have severe varicose veins.I have not had bariatric surgery or liposuction in the last 3 years.I have rheumatoid arthritis.I have a genetic condition that affects blood clotting.I have been diagnosed with Type 2 Diabetes.I have cancer and may or may not be on chemotherapy.My family has a history of blood clots in the veins or lungs.I am between 18 and 40 years old and in good health.I have nerve damage in my hands or feet.I often wake up at night to urinate or I have sleep apnea.I am on blood thinners or anti-platelet medications that can't be stopped for tests.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1 - Regular exercise
- Group 2: Group 2 - Athlete exercise
- Group 3: Group 3 - Obese No Exercise
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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