Insulin ResistanceNCT02230839

Muscle Insulin Resistance in Aging (Mirage)

A study testing Exercise and Energy Restriction-Induced Weight Loss in people with Insulin Resistance and Sarcopenia, run by AdventHealth Translational Research Institute at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

The purpose of this study is to provide information regarding potential factors underlying metabolic dysfunction, insulin resistance, and loss of muscle mass in aging muscle. Read more about this study

Who is it for?: Ages 65 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Insulin Resistance, Sarcopenia
What is being tested?: Exercise and Energy Restriction-Induced Weight Loss
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteUnited States
Study dates: Jun 2014to Dec 2025
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 to 80 years
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

65-80 years of age
Stable weight (No Gain/Loss of >10 lbs in 6 months)
Sedentary (≤ 1 continuous exercise/week)
Non-smoker
BMI ≥ 30 kg/m2
Resting Blood Pressure ≤ 150 millimeters of mercury systolic and ≤ 95 millimeters of mercury diastolic
Note from Primary care physician/Cardiologist for exercise clearance if positive stress test symptoms were observed from exercise test
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)

Who cannot join

Clinically significant cardiovascular disease including history of myocardial infarction, within the past year
Peripheral Vascular Disease
Hepatic, renal, muscular/neuromuscular, or active hematologic/oncologic disease
Clinically diminished pulse
Presence of bruits in lower extremities
Previous history of pulmonary emboli
Peripheral Neuropathy

Trial locations and contacts

1 site in 1 country.

United States1 site

Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, 32804

Other trials in United States

About this study

Official title: Muscle Insulin Resistance In Aging

The purpose of this study is to provide information regarding potential factors underlying metabolic dysfunction, insulin resistance, and loss of muscle mass in aging muscle.

Read the detailed description

Study Objectives:

To determine the effects of diet-induced weight loss with and without the addition of exercise on mitochondrial biogenesis and energetic capacity, cellular redox state and insulin resistance.
To determine the effects of diet-induced weight loss with and without the addition of exercise on intramyocellular lipid profiles.
To determine the effects of diet-induced weight loss with and without exercise on skeletal muscle proteins mediating a program of autophagy and either loss or maintenance of muscle mass.

Conditions: Insulin Resistance, Sarcopenia
Being tested: Exercise, Energy Restriction-Induced Weight Loss
Keywords: insulin resistance, muscle, health education, exercise
Medical subject headings: Insulin Resistance, Sarcopenia, Health Education, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ExerciseBehavioural
Participants will complete a progressive 6-month exercise training program, 4-5 days per week, 45 min per session (180 min per week), consisting mostly of walking (both outside and on an indoor treadmill) but with the option to include stationary cycling, elliptical and rowing machines, similar to what we have utilized previously to elicit significant improvements in insulin sensitivity in both middle-age and older adults (52-55). Beginning at week 8, these subjects will also perform 2 non-consecutive resistance exercise sessions per week, 30 min per session, focused on major muscle groups using resistance machines (total days of exercise will still be 4 to 5).
Energy Restriction-Induced Weight LossBehavioural
The goal of the weight loss intervention will be to produce a weight loss of 10% body weight. A reduction of 500-1000 kcal/day - based on baseline weight -and low fat (<30% of calories from fat) diet will be used as part of the weight loss intervention.

Study groups in NCT02230839
Study group	Role	What they receive
Exercise training protocol	Experimental	Not described Receives: Behavioral: Exercise
Energy restriction-induced weight loss	Experimental	Not described Receives: Behavioral: Energy Restriction-Induced Weight Loss
Health Education	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Measure of intramyocellular lipids
A percutaneous muscle biopsy of the vastus lateralis will be obtained, and the intramyocellular lipids will be measured by high-performance liquid chromatography-tandem mass spectrometry.
Measured: Visit 3 ~22 hours

Secondary outcomes (1)

Measure of insulin sensitivity
Insulin sensitivity will be measured using an intravenous catheter (glucose clamps) that will be placed in the antecubital vein for subsequent insulin and glucose infusions and for stable isotope infusions. This will measure insulin-stimulated changes in insulin signaling proteins and metabolism.
Measured: Visit 3 ~22 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Dec 2025

First posted3 Sep 2014 (estimated)
Study startJun 2014
Primary completion31 Dec 2023
Study completionDec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (62)Papers the sponsor has linked to this study.
Other trials for Insulin ResistanceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02230839
Sponsor's protocol ID: TRIMDFH 500423
Status last verified: Aug 2025
First submitted: 7 Aug 2014
Last updated: 3 Aug 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Evans W. Functional and metabolic consequences of sarcopenia. J Nutr. 1997 May;127(5 Suppl):998S-1003S. doi: 10.1093/jn/127.5.998S.
PubMed 9164283
Evans WJ, Campbell WW. Sarcopenia and age-related changes in body composition and functional capacity. J Nutr. 1993 Feb;123(2 Suppl):465-8. doi: 10.1093/jn/123.suppl_2.465.
PubMed 8429405
Rosenberg IH. Sarcopenia: origins and clinical relevance. J Nutr. 1997 May;127(5 Suppl):990S-991S. doi: 10.1093/jn/127.5.990S.
PubMed 9164280
Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.
PubMed 16595758
Villareal DT, Apovian CM, Kushner RF, Klein S; American Society for Nutrition; NAASO, The Obesity Society. Obesity in older adults: technical review and position statement of the American Society for Nutrition and NAASO, The Obesity Society. Am J Clin Nutr. 2005 Nov;82(5):923-34. doi: 10.1093/ajcn/82.5.923.
PubMed 16280421
Goodpaster BH, Carlson CL, Visser M, Kelley DE, Scherzinger A, Harris TB, Stamm E, Newman AB. Attenuation of skeletal muscle and strength in the elderly: The Health ABC Study. J Appl Physiol (1985). 2001 Jun;90(6):2157-65. doi: 10.1152/jappl.2001.90.6.2157.
PubMed 11356778
Park SW, Goodpaster BH, Lee JS, Kuller LH, Boudreau R, de Rekeneire N, Harris TB, Kritchevsky S, Tylavsky FA, Nevitt M, Cho YW, Newman AB; Health, Aging, and Body Composition Study. Excessive loss of skeletal muscle mass in older adults with type 2 diabetes. Diabetes Care. 2009 Nov;32(11):1993-7. doi: 10.2337/dc09-0264. Epub 2009 Jun 23.
PubMed 19549734
Petersen KF, Befroy D, Dufour S, Dziura J, Ariyan C, Rothman DL, DiPietro L, Cline GW, Shulman GI. Mitochondrial dysfunction in the elderly: possible role in insulin resistance. Science. 2003 May 16;300(5622):1140-2. doi: 10.1126/science.1082889.
PubMed 12750520
Amati F, Dube JJ, Coen PM, Stefanovic-Racic M, Toledo FG, Goodpaster BH. Physical inactivity and obesity underlie the insulin resistance of aging. Diabetes Care. 2009 Aug;32(8):1547-9. doi: 10.2337/dc09-0267. Epub 2009 Apr 28.
PubMed 19401446
Kelley DE, Goodpaster B, Wing RR, Simoneau JA. Skeletal muscle fatty acid metabolism in association with insulin resistance, obesity, and weight loss. Am J Physiol. 1999 Dec;277(6):E1130-41. doi: 10.1152/ajpendo.1999.277.6.E1130.
PubMed 10600804
Kelley DE, Mintun MA, Watkins SC, Simoneau JA, Jadali F, Fredrickson A, Beattie J, Theriault R. The effect of non-insulin-dependent diabetes mellitus and obesity on glucose transport and phosphorylation in skeletal muscle. J Clin Invest. 1996 Jun 15;97(12):2705-13. doi: 10.1172/JCI118724.
PubMed 8675680
Lillioja S, Bogardus C. Obesity and insulin resistance: lessons learned from the Pima Indians. Diabetes Metab Rev. 1988 Aug;4(5):517-40. doi: 10.1002/dmr.5610040508.
PubMed 3061759
Devlin JT. Effects of exercise on insulin sensitivity in humans. Diabetes Care. 1992 Nov;15(11):1690-3. doi: 10.2337/diacare.15.11.1690.
PubMed 1468302
Bogardus C. Insulin resistance in the pathogenesis of NIDDM in Pima Indians. Diabetes Care. 1993 Jan;16(1):228-31. doi: 10.2337/diacare.16.1.228.
PubMed 8422780
Haffner SM, Valdez RA, Hazuda HP, Mitchell BD, Morales PA, Stern MP. Prospective analysis of the insulin-resistance syndrome (syndrome X). Diabetes. 1992 Jun;41(6):715-22. doi: 10.2337/diab.41.6.715.
PubMed 1587398

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Insulin Resistance trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Muscle Insulin Resistance In Aging
ClinicalTrials.gov ID: NCT02230839
Acronym / sponsor ID: TRIMDFH 500423
Conditions: Insulin Resistance, Sarcopenia
Keywords: insulin resistance, muscle, health education, exercise
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 200 participants (estimated)
Lead sponsor: AdventHealth Translational Research InstituteUniversity, hospital or other
Study start: Jun 2014
Primary completion: 31 Dec 2023 (actual)
Study completion: Dec 2025 (estimated)
First posted: 3 Sep 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to provide information regarding potential factors underlying metabolic dysfunction, insulin resistance, and loss of muscle mass in aging muscle.

Detailed description

Study Objectives:

To determine the effects of diet-induced weight loss with and without the addition of exercise on mitochondrial biogenesis and energetic capacity, cellular redox state and insulin resistance.
To determine the effects of diet-induced weight loss with and without the addition of exercise on intramyocellular lipid profiles.
To determine the effects of diet-induced weight loss with and without exercise on skeletal muscle proteins mediating a program of autophagy and either loss or maintenance of muscle mass.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Exercise training protocol	Experimental	Behavioral: Exercise
Energy restriction-induced weight loss	Experimental	Behavioral: Energy Restriction-Induced Weight Loss
Health Education	No intervention	–

Who may qualify

Ages: 65 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (8 listed)

65-80 years of age
Stable weight (No Gain/Loss of >10 lbs in 6 months)
Sedentary (≤ 1 continuous exercise/week)
Non-smoker
BMI ≥ 30 kg/m2

Key exclusion criteria (7 listed)

Clinically significant cardiovascular disease including history of myocardial infarction, within the past year
Peripheral Vascular Disease
Hepatic, renal, muscular/neuromuscular, or active hematologic/oncologic disease
Clinically diminished pulse
Presence of bruits in lower extremities

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ExerciseParticipants will complete a progressive 6-month exercise training program, 4-5 days per week, 45 min per session (180 min per week), consisting mostly of walking (both outside and on an indoor treadmill) but with the option to include stationary cycling, elliptical and rowing machines, similar to what we have utilized previously to elicit significant improvements in insulin sensitivity in both middle-age and older adults (52-55). Beginning at week 8, these subjects will also perform 2 non-consecutive resistance exercise sessions per week, 30 min per session, focused on major muscle groups using resistance machines (total days of exercise will still be 4 to 5).	Behavioural	Exercise training protocol
Energy Restriction-Induced Weight LossThe goal of the weight loss intervention will be to produce a weight loss of 10% body weight. A reduction of 500-1000 kcal/day - based on baseline weight -and low fat (<30% of calories from fat) diet will be used as part of the weight loss intervention.	Behavioural	Energy restriction-induced weight loss

Primary outcome

Measure of intramyocellular lipids
Time frame: Visit 3 ~22 hours
A percutaneous muscle biopsy of the vastus lateralis will be obtained, and the intramyocellular lipids will be measured by high-performance liquid chromatography-tandem mass spectrometry.

1 secondary outcome

Measure of insulin sensitivity
Time frame: Visit 3 ~22 hours

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
Background: PubMed 9164283Evans W. Functional and metabolic consequences of sarcopenia. J Nutr. 1997 May;127(5 Suppl):998S-1003S. doi: 10.1093/jn/127.5.998S.
Background: PubMed 8429405Evans WJ, Campbell WW. Sarcopenia and age-related changes in body composition and functional capacity. J Nutr. 1993 Feb;123(2 Suppl):465-8. doi: 10.1093/jn/123.suppl_2.465.
Background: PubMed 9164280Rosenberg IH. Sarcopenia: origins and clinical relevance. J Nutr. 1997 May;127(5 Suppl):990S-991S. doi: 10.1093/jn/127.5.990S.
Background: PubMed 16595758Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.
Background: PubMed 16280421Villareal DT, Apovian CM, Kushner RF, Klein S; American Society for Nutrition; NAASO, The Obesity Society. Obesity in older adults: technical review and position statement of the American Society for Nutrition and NAASO, The Obesity Society. Am J Clin Nutr. 2005 Nov;82(5):923-34. doi: 10.1093/ajcn/82.5.923.
Background: PubMed 11356778Goodpaster BH, Carlson CL, Visser M, Kelley DE, Scherzinger A, Harris TB, Stamm E, Newman AB. Attenuation of skeletal muscle and strength in the elderly: The Health ABC Study. J Appl Physiol (1985). 2001 Jun;90(6):2157-65. doi: 10.1152/jappl.2001.90.6.2157.
Background: PubMed 19549734Park SW, Goodpaster BH, Lee JS, Kuller LH, Boudreau R, de Rekeneire N, Harris TB, Kritchevsky S, Tylavsky FA, Nevitt M, Cho YW, Newman AB; Health, Aging, and Body Composition Study. Excessive loss of skeletal muscle mass in older adults with type 2 diabetes. Diabetes Care. 2009 Nov;32(11):1993-7. doi: 10.2337/dc09-0264. Epub 2009 Jun 23.
Background: PubMed 12750520Petersen KF, Befroy D, Dufour S, Dziura J, Ariyan C, Rothman DL, DiPietro L, Cline GW, Shulman GI. Mitochondrial dysfunction in the elderly: possible role in insulin resistance. Science. 2003 May 16;300(5622):1140-2. doi: 10.1126/science.1082889.
Background: PubMed 19401446Amati F, Dube JJ, Coen PM, Stefanovic-Racic M, Toledo FG, Goodpaster BH. Physical inactivity and obesity underlie the insulin resistance of aging. Diabetes Care. 2009 Aug;32(8):1547-9. doi: 10.2337/dc09-0267. Epub 2009 Apr 28.
Background: PubMed 10600804Kelley DE, Goodpaster B, Wing RR, Simoneau JA. Skeletal muscle fatty acid metabolism in association with insulin resistance, obesity, and weight loss. Am J Physiol. 1999 Dec;277(6):E1130-41. doi: 10.1152/ajpendo.1999.277.6.E1130.
Background: PubMed 8675680Kelley DE, Mintun MA, Watkins SC, Simoneau JA, Jadali F, Fredrickson A, Beattie J, Theriault R. The effect of non-insulin-dependent diabetes mellitus and obesity on glucose transport and phosphorylation in skeletal muscle. J Clin Invest. 1996 Jun 15;97(12):2705-13. doi: 10.1172/JCI118724.
Background: PubMed 3061759Lillioja S, Bogardus C. Obesity and insulin resistance: lessons learned from the Pima Indians. Diabetes Metab Rev. 1988 Aug;4(5):517-40. doi: 10.1002/dmr.5610040508.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bret Goodpaster, PhD principal investigator

Translational Research Institute for Metabolism and Diabetes

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Exercise and Energy Restriction-Induced Weight Loss in people with Insulin Resistance and Sarcopenia, run by AdventHealth Translational Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measure of intramyocellular lipids (time frame: Visit 3 ~22 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02230839, which also lists 62 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.