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Behavioral Intervention

Weight Loss and Exercise for Insulin Resistance in Aging

N/A
Waitlist Available
Led By Bret Goodpaster, PhD
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
Must be willing to washout for 14 days from all diabetes medication and independent in self blood glucose monitoring during the washout periods (those with diabetes only)
65-80 years of age
Must not have
Hepatic, renal, muscular/neuromuscular, or active hematologic/oncologic disease
Clinically significant cardiovascular disease including history of myocardial infarction, within the past year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 2 (baseline) and 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will help researchers understand potential causes of age-related metabolic problems and muscle loss.

Who is the study for?
The MIRAGE study is for older adults aged 65-80 who are overweight, sedentary, non-smokers with stable weight and blood pressure within certain limits. Those with diabetes must be able to monitor their own blood sugar after stopping medication for two weeks. People with recent heart attacks, vascular diseases, neuropathy or serious liver, kidney or muscle conditions cannot join.
What is being tested?
This trial investigates how energy restriction-induced weight loss and exercise can affect insulin resistance and muscle mass in aging individuals. It aims to uncover factors contributing to metabolic dysfunction in the elderly.
What are the potential side effects?
Potential side effects from participating may include typical risks associated with starting an exercise regimen or changing diet such as muscle soreness, fatigue, nutritional deficiencies or hypoglycemia especially in those who have diabetes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to stop my diabetes medications for 14 days and can monitor my blood sugar by myself.
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I am between 65 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have active liver, kidney, muscle, or blood cancer conditions.
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I have had a heart attack in the last year.
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I have peripheral vascular disease.
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I do not have numbness, tingling, or pain in my hands or feet.
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I have had blood clots in my lungs before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 2 (baseline) and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 2 (baseline) and 6 months 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 of intramyocellular lipids
Secondary study objectives
Measure of insulin sensitivity
Other study objectives
Measure muscle strength and power

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Exercise training protocolExperimental Treatment1 Intervention
Group II: Energy restriction-induced weight lossExperimental Treatment1 Intervention
Group III: Health EducationActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise
2016
Completed Phase 1
~820

Find a Location

Who is running the clinical trial?

Translational Research Institute for Metabolism and Diabetes, FloridaLead Sponsor
40 Previous Clinical Trials
3,464 Total Patients Enrolled
2 Trials studying Sarcopenia
75 Patients Enrolled for Sarcopenia
AdventHealth Translational Research InstituteLead Sponsor
50 Previous Clinical Trials
5,764 Total Patients Enrolled
2 Trials studying Sarcopenia
75 Patients Enrolled for Sarcopenia
Bret Goodpaster, PhDPrincipal InvestigatorTranslational Research Institute for Metabolism and Diabetes
5 Previous Clinical Trials
314 Total Patients Enrolled

Media Library

Energy Restriction-Induced Weight Loss (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT02230839 — N/A
Sarcopenia Research Study Groups: Exercise training protocol, Energy restriction-induced weight loss, Health Education
Sarcopenia Clinical Trial 2023: Energy Restriction-Induced Weight Loss Highlights & Side Effects. Trial Name: NCT02230839 — N/A
Energy Restriction-Induced Weight Loss (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02230839 — N/A
~0 spots leftby Dec 2024
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