Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
200 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-06-30
Study Completion Date
2025-12-31
Brief Summary
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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.
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Detailed Description
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Study Objectives:
1. 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.
2. To determine the effects of diet-induced weight loss with and without the addition of exercise on intramyocellular lipid profiles.
3. 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.
1. 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.
2. To determine the effects of diet-induced weight loss with and without the addition of exercise on intramyocellular lipid profiles.
3. 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
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Insulin Resistance
Sarcopenia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
BASIC_SCIENCE
Blinding Strategy
NONE
Study Groups
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Exercise training protocol
Group Type
EXPERIMENTAL
Exercise
Intervention Type
BEHAVIORAL
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 loss
Group Type
EXPERIMENTAL
Energy Restriction-Induced Weight Loss
Intervention Type
BEHAVIORAL
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.
Health Education
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Exercise
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).
Intervention Type
BEHAVIORAL
Energy Restriction-Induced Weight Loss
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.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* 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)
* 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)
Exclusion Criteria
* 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
* 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
Minimum Eligible Age
65 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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AdventHealth Translational Research Institute
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Bret Goodpaster, PhD
Role: PRINCIPAL_INVESTIGATOR
Translational Research Institute for Metabolism and Diabetes
Locations
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Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, United States
Site Status
Countries
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United States
References
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Related Links
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http://www.tri-md.org
Florida Hospital Translational Research Institute for Metabolism and Diabetes
Other Identifiers
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TRIMDFH 500423
Identifier Type: -
Identifier Source: org_study_id
NCT01808924
Identifier Type: -
Identifier Source: nct_alias
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COMPLETED
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Mechanisms of Skeletal Muscle Insulin Resistance in Older Adults
NCT02971098
COMPLETED
NA
Effects of 12- Weeks of Quantitative Weight-bearing Progressive Resistance Exercise Training on Glycemia Control and Improving Muscle Strength With Type 2 Diabetes Combine Pre-sarcopenia.
NCT04647617
COMPLETED
NA
Nutrition, Exercise and Muscle Metabolism in Obesity
NCT02397304
UNKNOWN
NA
Effects of Simulated Passive Jogging Device on Glucose Homeostasis, Muscle Strength and Endurance
NCT03550105
COMPLETED
NA
Acute Exercise and Endogenous Glucose Production in Type 2 Diabetes: Implications for Glycemic Control and Treatment of Hepatic Steatosis
NCT06993454
RECRUITING
NA
Basic Research Study to Examine the Relation Between Muscle Insulin Resistance and Lipid Production in the Liver.
NCT02196051
COMPLETED
NA
Effect of Exercise Intervention on Various Physiologic Factors That Change With Increasing Age
NCT00283673
COMPLETED
NA
The Effects of Exercise of Secreted Factors From Muscle and Adipose Tissue
NCT02565823
COMPLETED
NA
Aerobic and Strength Training With Caloric Restriction on Insulin Resistance in Obese Premenopausal Women
NCT03716336
COMPLETED
NA
Weight Loss and/or Exercise Training to Discover Muscle Lipids Related to Insulin Sensitivity
NCT02043405
COMPLETED
NA
Resistance Exercise Effect on Physical Performance and Functional Status in Sarcopenic Older Women
NCT01829009
WITHDRAWN
NA
Metabolic Study of Concentric and Eccentric Muscle Training
NCT00386854
COMPLETED
NA
Resistance Training for the Improvement of Glycemic Control in Prediabetes
NCT06697756
ACTIVE_NOT_RECRUITING
NA
Restoring 24-hour Substrate Rhythmicity to Improve Glycemic Control by Timing of Lifestyle Factors
NCT05123963
RECRUITING
NA