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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 2 (baseline) and 6 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am willing to stop my diabetes medications for 14 days and can monitor my blood sugar by myself.
Select...
I am between 65 and 80 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Measure of intramyocellular lipids
Secondary outcome measures
Measure of insulin sensitivity
Other outcome measures
Measure muscle strength and power

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
~760

Find a Location

Who is running the clinical trial?

Translational Research Institute for Metabolism and Diabetes, FloridaLead Sponsor
40 Previous Clinical Trials
3,397 Total Patients Enrolled
2 Trials studying Sarcopenia
75 Patients Enrolled for Sarcopenia
AdventHealth Translational Research InstituteLead Sponsor
48 Previous Clinical Trials
19,981 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
280 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Diabetes / Metabolism ReviewsJournal
Obesity and Insulin Resistance: Lessons Learned from the Pima Indians
Lillioja, S., and C. Bogardus. 1988. “Obesity and Insulin Resistance: Lessons Learned from the Pima Indians”. Diabetes / Metabolism Reviews. Wiley. doi:10.1002/dmr.5610040508.
DiabetesJournal
Mechanism and Significance of Insulin Resistance in Non-insulin-dependent Diabetes Mellitus
Rizza, Robert A, Lawrence J Mandarino, and John E Gerich. 1981. “Mechanism and Significance of Insulin Resistance in Non-insulin-dependent Diabetes Mellitus”. Diabetes. American Diabetes Association. doi:10.2337/diab.30.12.990.
Journal of Biological ChemistryJournal
A Role for Ceramide, but Not Diacylglycerol, in the Antagonism of Insulin Signal Transduction by Saturated Fatty Acids
Chavez, Jose Antonio, Trina A. Knotts, Li-Ping Wang, Guibin Li, Rick T. Dobrowsky, Gregory L. Florant, and Scott A. Summers. 2003. “A Role for Ceramide, but Not Diacylglycerol, in the Antagonism of Insulin Signal Transduction by Saturated Fatty Acids”. Journal of Biological Chemistry. Elsevier BV. doi:10.1074/jbc.m212307200.
DiabetesJournal
Lipid-induced Insulin Resistance in Human Muscle Is Associated with Changes in Diacylglycerol, Protein Kinase C, and Iκb-α
Itani, Samar I., Neil B. Ruderman, Frank Schmieder, and Guenther Boden. 2002. “Lipid-induced Insulin Resistance in Human Muscle Is Associated with Changes in Diacylglycerol, Protein Kinase C, and Iκb-α”. Diabetes. American Diabetes Association. doi:10.2337/diabetes.51.7.2005.
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