ClinicalTrials.gov
ClinicalTrials.gov Menu

Muscle Perfusion and Protein Metabolism in Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00945256
Recruitment Status : Completed
First Posted : July 24, 2009
Results First Posted : January 5, 2016
Last Update Posted : February 3, 2016
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

July 22, 2009
July 24, 2009
March 28, 2013
January 5, 2016
February 3, 2016
May 2003
May 2008   (Final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00945256 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Muscle Perfusion and Protein Metabolism in Elderly
A Phase I Trial Examining Muscle Perfusion and Protein Metabolism in Elderly and Young
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.
The purpose of this study was to examine muscle protein metabolism in healthy young and elderly subjects during pharmacologic vasodilation of the lower limb vasculature in combination with increased amino acids delivery. We obtained femoral arteriovenous blood samples and v. lateralis muscle biopsies during a primed continuous infusion of L-[ring-13C6] Phenylalanine. Muscle protein kinetics were measured in the basal state and during a 180 min infusion of sodium nitroprusside (SNP) and amino acids (Premsol 10%) (SNP+AA). Skeletal muscle microvascular recruitment and flow were measured during the basal state and SNP+AA using contrast-enhanced ultrasound (CEU).
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Aging
  • Other: Aerobic Exercise
    45 minuties of treadmill walking was completed at 40% VO2 peak
  • 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
  • Active Comparator: Young Aerobic Exercise
    45 minutes of treadmill walking at 40% VO2 peak
    Intervention: Other: Aerobic Exercise
  • Active Comparator: Elderly Aerobic Exercise
    45 minutes of treadmill walking at 40% VO2 peak
    Intervention: Other: Aerobic Exercise
  • Active Comparator: Young Sodium Nitroprusside
    Sodium Nitroprusside given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min
    Intervention: Drug: Sodium Nitroprusside
  • Active Comparator: Elderly Sodium Nitoprusside
    Sodium Nitroprusside given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min
    Intervention: Drug: Sodium Nitroprusside
  • 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
    Interventions:
    • Drug: Sodium Nitroprusside
    • Dietary Supplement: Amino Acid Drink
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
48
May 2009
May 2008   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00945256
03-213
R01AG021539 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
The University of Texas Medical Branch, Galveston
The University of Texas Medical Branch, Galveston
National Institute on Aging (NIA)
Principal Investigator: Melinda Sheffield-Moore, PhD UTMB
The University of Texas Medical Branch, Galveston
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP