Insulin Resistance Clinical Trial
Official title:
Muscle Insulin Resistance In Aging
Verified date | January 2024 |
Source | AdventHealth Translational Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Translational Research Institute for Metabolism and Diabetes | Orlando | Florida |
Lead Sponsor | Collaborator |
---|---|
AdventHealth Translational Research Institute |
United States,
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* Note: There are 61 references in all — Click here to view all references
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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