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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02230839
Other study ID # TRIMDFH 500423
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 2014
Est. completion date December 2024

Study information

Verified date January 2024
Source AdventHealth Translational Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Description:

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.


Other known NCT identifiers
  • NCT01808924

Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 80 Years
Eligibility 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) 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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).
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.

Locations

Country Name City State
United States Translational Research Institute for Metabolism and Diabetes Orlando Florida

Sponsors (1)

Lead Sponsor Collaborator
AdventHealth Translational Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (61)

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* Note: There are 61 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Measure muscle strength and power Muscle strength and power will be measured in participants who have successfully completed all screening procedures.
Measurement is obtained using a short physical performance battery, knee extension, and muscle power testing using a pneumatic-driven dynamometer.
Visit 2 (baseline) and 6 months
Primary 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. Visit 3 ~22 hours
Secondary 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. Visit 3 ~22 hours
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