Muscle Perfusion and Protein Metabolism in Elderly
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ClinicalTrials.gov Identifier: NCT00945256 |
Recruitment Status
:
Completed
First Posted
: July 24, 2009
Results First Posted
: January 5, 2016
Last Update Posted
: February 3, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Aging | Other: Aerobic Exercise Drug: Sodium Nitroprusside Dietary Supplement: Amino Acid Drink | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 62 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Official Title: | A Phase I Trial Examining Muscle Perfusion and Protein Metabolism in Elderly and Young |
Study Start Date : | May 2003 |
Actual Primary Completion Date : | May 2008 |
Actual Study Completion Date : | May 2009 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Young Aerobic Exercise
45 minutes of treadmill walking at 40% VO2 peak
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Other: Aerobic Exercise
45 minuties of treadmill walking was completed at 40% VO2 peak
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Active Comparator: Elderly Aerobic Exercise
45 minutes of treadmill walking at 40% VO2 peak
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Other: Aerobic Exercise
45 minuties of treadmill walking was completed at 40% VO2 peak
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Active Comparator: Young Sodium Nitroprusside
Sodium Nitroprusside given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min
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Drug: Sodium Nitroprusside
Sodium Nitroprusside was given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min
Other Name: Nitropress
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Active Comparator: Elderly Sodium Nitoprusside
Sodium Nitroprusside given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min
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Drug: Sodium Nitroprusside
Sodium Nitroprusside was given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min
Other Name: Nitropress
|
Active Comparator: Elderly Sodium Nitroprusside and Amino Acid Drink
Sodium Nitroprusside given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min and 7.5g amino acid drink taken orally
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Drug: Sodium Nitroprusside
Sodium Nitroprusside was given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min
Other Name: Nitropress
Dietary Supplement: Amino Acid Drink
7.5 gram Amino Acid drink
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- Mixed Muscle Fractional Synthesis Rate (FSR) [ Time Frame: Acute ( 8 hours) ]The rate at which the body makes new muscle was assessed by determining the fractional synthesis rate (FSR). This technique determines how quickly new amino acids are used to make muscle. In this technique, a special (but natural and non-radioactive) version of an amino acid is infused into the blood. This special version of the amino acid is heavier than the most common version the same amino acid. This property allows it to be identified in a muscle sample. By determining how much of the special amino acid has accumulated over time in a muscle sample, the fractional synthesis rate can be determined. For example, if the rate were such that 1 of every 100 amino acids were of the special type after 1 day, the fractional synthesis rate would be 1% per day. In other words, 1/100 of the muscle would be newly made each day.

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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 (< 1.0).
- Any subject with blood pressure on three consecutive measurements taken at rest on separate occasions that has a systolic pressure >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 <13 g/dL in males or <12 g/dL in females).
- Any history of hypo- or hyper-coagulation disorders, including patients taking Coumadin or with a history of deep venous thrombosis (DVT) or pulmonary embolism (PE) at any point in their lifetimes.
- Currently taking aspirin and cannot stop for 7 days (i.e., medical indication for continued aspirin such as transient ischemic attacks).
- Presence of acute illness or metabolically unstable chronic illness.
- Heart disease requiring therapy or recent myocardial infarction (less than 1 year)
- Currently on weight-loss diet.
- Active cancer or in short-term remission (less than 3 years).
- Alcohol or drug abuse.
- History of >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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00945256
Principal Investigator: | Melinda Sheffield-Moore, PhD | UTMB |
Responsible Party: | The University of Texas Medical Branch, Galveston |
ClinicalTrials.gov Identifier: | NCT00945256 History of Changes |
Other Study ID Numbers: |
03-213 R01AG021539 ( U.S. NIH Grant/Contract ) |
First Posted: | July 24, 2009 Key Record Dates |
Results First Posted: | January 5, 2016 |
Last Update Posted: | February 3, 2016 |
Last Verified: | April 2014 |
Keywords provided by The University of Texas Medical Branch, Galveston:
metabolism exercise sodium nitroprusside |
Additional relevant MeSH terms:
Nitroprusside Antihypertensive Agents Vasodilator Agents Nitric Oxide Donors Molecular Mechanisms of Pharmacological Action |