Phase 1
N=62
Muscle Perfusion and Protein Metabolism in Elderly
Aging
Bottom Line
View on ClinicalTrials.gov: NCT00945256 ↗Enrolled (actual)
62
Serious AEs
1.6%
Results posted
Jan 2016
Primary outcome: Primary: Mixed Muscle Fractional Synthesis Rate (FSR) — 0.061; 0.070; 0.066; 0.070 Fractional Synthesis Rate (pecent/hour)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Aerobic Exercise (Other); Sodium Nitroprusside (Drug); Amino Acid Drink (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Medical Branch, Galveston
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mixed Muscle Fractional Synthesis Rate (FSR) |
0.061; 0.070; 0.066; 0.070; NA; 0.098 | — |
Summary
The purpose of this study was to examine the role skeletal muscle perfusion plays in mediating muscle protein synthesis in healthy older and younger individuals. The investigators hypothesized that normalization of muscle perfusion in older men and women via exercise or infusion of a vasodilator would enhance nutritive flow and skeletal muscle protein synthesis in the elderly similar to that of their younger counterparts.
Eligibility Criteria
Inclusion Criteria
All inclusion criteria must be fulfilled throughout the study. At enrollment, subjects must fit the following criteria:
- Age: young 18-40 yrs; elderly 60-85 yrs.
- Availability of transportation (i.e., subjects must be able to provide their own transportation to UTMB).
- Ability to sign informed consent (score >24 on 30 item mini-mental status exam and no errors on assessment of judgment).
Exclusion Criteria
None of the following exclusion criteria should be present at enrollment or throughout the study:
- Patients with limiting or unstable angina or who demonstrate cardiac abnormalities such as > 0.2 mV horizontal or downsloping ST segment depression, frequent arrhythmias (>10 PVC/min), or valvular disease.
- Any patient with atrial fibrillation, history of syncope, angina, or congestive heart failure.
- Patients with vascular disease, as determined by the presence of risk factors of peripheral atherosclerosis (i.e., hypertension, obesity, uncontrolled diabetes, and evidence of venous or arterial insufficiency upon palpation of femoral, popliteal, and pedal arteries).
- Peripheral vascular disease as determined by history or abnormal ankle-brachial index by Doppler ( 170 mm Hg or a diastolic blood pressure >100 mm Hg will be excluded. Subjects will not be included if they are taking blood pressure medication and have a blood pressure above these criteria.
- Any person HIV-seropositive, with active hepatitis, or any other immunosuppressive or autoimmune disease.
- Any patient taking beta blockers, vasodilators, angiotensin-converting enzyme inhibitors, calcium channel blockers, or alpha blockers.
- Any patient with uncontrolled metabolic diseases including any patient with liver or renal disease.
- Glucose intolerance: fasting plasma glucose concentration 110-126 mg/dL (6.1-7 mmol/L) and/or 2-h plasma glucose 140-200 mg/dL (7.8-11.1 mmol/L) during oral glucose tolerance test (OGTT).
- Currently in muscle strengthening program.
- Total knee replacement or moderate to severe degenerative joint disease of knees.
- Anemia (hemoglobin 20 packs per year cigarette smoking.
- Recent (within 6 months) ingestion or injection or transdermal administration of anabolic steroids, corticosteroids, estrogens, or progestagens.
- History of falls (1 fall in the past year which required medical attention, or more than 2 falls/year regardless of severity).
- Allergy to iodides, penicillin or shellfish.
- Any subject with a know hypersensitivity to octafluoropropane.
- Any subject with a cardiac shunt.
- Any subject with chronic obstructive pulmonary disease (COPD).
Data sourced from ClinicalTrials.gov (NCT00945256). 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.