Physical Inactivity Clinical Trial
Official title:
Translational Control of Anabolic Resistance in Aging Muscle
Verified date | June 2022 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is an interventional study enrolling older individuals aged 60-85y to observe changes during physical inactivity. This study is investigating the relation between short-term physical inactivity and the impact of muscle health and function. The enrollment goal is 8 participants. The study will occur over the course of a month where participants will undergo testing before and after a reduction in physically activity levels. There will be a screening event collecting baseline data, two body composition scans, muscle function and oral glucose tolerance tests and a metabolic study before and after a 2-week period of inactivity. Each metabolic study will entail three-muscle biopsies: one before and 2 after the ingestion of leucine.
Status | Completed |
Enrollment | 9 |
Est. completion date | December 17, 2019 |
Est. primary completion date | December 17, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years to 85 Years |
Eligibility | Inclusion Criteria: - Age between 60-85 years - Ability to sign informed consent - Free-living, prior to admission Exclusion Criteria: - Cardiac abnormalities considered exclusionary by the study physician (e.g., Chronic heart Failure, right-to-left shunt) - Uncontrolled endocrine or metabolic disease (e.g., hypo/hyperthyroidism, diabetes) - History of kidney disease or failure - Vascular disease or risk factors of peripheral atherosclerosis. (e.g., uncontrolled hypertension, obesity, diabetes, hypercholesterolemia > 250 mg/dl, claudication or evidence of venous or arterial insufficiency upon palpitation of femoral, popliteal and pedal arteries) - Risk of blood clotting including family history of thrombophilia, pulmonary emboli, myeloproliferative diseases including polycythemia (Hb>18 g/dL) or thrombocytosis (platelets>400x103/mL), and connective tissue diseases (positive lupus anticoagulant), hyperhomocystinemia, deficiencies of factor V Leiden, proteins S and C, and antithrombine III - Use of anticoagulant therapy (e.g., Coumadin, heparin) - Elevated systolic pressure >150 or a diastolic blood pressure > 100 - Cancer or history of successfully treated cancer (less than 1 year) other than basal cell carcinoma - Implanted electronic devices (e.g., pacemakers, electronic infusion pumps, stimulators) - Currently on a weight-loss diet or body mass index > 30 kg/m2 - Chronic systemic corticosteroid use (= 2 weeks) within 4 weeks of enrollment and for study duration (intra-articular/topical/inhaled therapeutic or physiologic doses of corticosteroids are permitted). Androgens or growth hormone within 6 months of enrollment and for study duration (topical physiologic androgen replacement is permitted) - History of stroke with motor disability - A recent history (<12 months) of GI bleed - History of liver disease - History of respiratory disease (acute upper respiratory infection, history of chronic lung disease) - Prior history of Heparin-Induced Thrombocytopenia - An HbA1c value at or greater than 6.5% - Any other condition or event considered exclusionary by the PI and faculty physician |
Country | Name | City | State |
---|---|---|---|
United States | University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lean Mass | Change in lean mass | baseline and 2-weeks | |
Primary | Strength | Change in muscle strength | baseline and 2-weeks |
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