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Muscle Perfusion and Protein Metabolism in Elderly

This study has been completed.
Sponsor:
Information provided by:
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00945256
First received: July 22, 2009
Last updated: October 14, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Aging
Metabolism
Other: Aerobic Exercise
Drug: Sodium Nitroprusside
Dietary Supplement: Amino Acids
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: A Phase I Trial Examining Muscle Perfusion and Protein Metabolism in Elderly and Young

Resource links provided by NLM:


Further study details as provided by The University of Texas, Galveston:

Enrollment: 48
Study Start Date: May 2003
Study Completion Date: May 2009
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Young vs Old Exercise Other: Aerobic Exercise
Active Comparator: Young vs Old SNP Drug: Sodium Nitroprusside
Experimental: Pre-Post Dietary Supplement: Amino Acids

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All inclusion criteria must be fulfilled throughout the study. At enrollment, subjects must fit the following criteria:

  1. Age: young 18-40 yrs; elderly 60-85 yrs.
  2. Availability of transportation (i.e., subjects must be able to provide their own transportation to UTMB).
  3. 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:

  1. 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.
  2. Any patient with atrial fibrillation, history of syncope, angina, or congestive heart failure.
  3. 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).
  4. Peripheral vascular disease as determined by history or abnormal ankle-brachial index by Doppler (< 1.0).
  5. 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.
  6. Any person HIV-seropositive, with active hepatitis, or any other immunosuppressive or autoimmune disease.
  7. Any patient taking beta blockers, vasodilators, angiotensin-converting enzyme inhibitors, calcium channel blockers, or alpha blockers.
  8. Any patient with uncontrolled metabolic diseases including any patient with liver or renal disease.
  9. 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).
  10. Currently in muscle strengthening program.
  11. Total knee replacement or moderate to severe degenerative joint disease of knees.
  12. Anemia (hemoglobin <13 g/dL in males or <12 g/dL in females).
  13. 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.
  14. Currently taking aspirin and cannot stop for 7 days (i.e., medical indication for continued aspirin such as transient ischemic attacks).
  15. Presence of acute illness or metabolically unstable chronic illness.
  16. Heart disease requiring therapy or recent myocardial infarction (less than 1 year)
  17. Currently on weight-loss diet.
  18. Active cancer or in short-term remission (less than 3 years).
  19. Alcohol or drug abuse.
  20. History of >20 packs per year cigarette smoking.
  21. Recent (within 6 months) ingestion or injection or transdermal administration of anabolic steroids, corticosteroids, estrogens, or progestagens.
  22. History of falls (1 fall in the past year which required medical attention, or more than 2 falls/year regardless of severity).
  23. Allergy to iodides, penicillin or shellfish.
  24. Any subject with a know hypersensitivity to octafluoropropane.
  25. Any subject with a cardiac shunt.
  26. Any subject with chronic obstructive pulmonary disease (COPD).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00945256

Sponsors and Collaborators
The University of Texas, Galveston
Investigators
Principal Investigator: Melinda Sheffield-Moore, PhD UTMB
  More Information

No publications provided

Responsible Party: Melinda Sheffield-Moore, PhD, The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00945256     History of Changes
Other Study ID Numbers: 03-213, AG21539
Study First Received: July 22, 2009
Last Updated: October 14, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Nitroprusside
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Nitric Oxide Donors
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 24, 2014