N/A
N=9
Translational Control of Anabolic Resistance in Aging Muscle
Physical Inactivity
Bottom Line
View on ClinicalTrials.gov: NCT03839628 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Lean Mass — 403 grams
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Reduced Physical Activity (Other)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lean Mass |
403 | — |
| PRIMARY Strength |
-8 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03839628). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.