Status:
COMPLETED
Anabolic and Inflammatory Responses to Short-Term Testosterone Administration in Older Men
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Conditions:
Sarcopenia
Eligibility:
MALE
60-85 years
Phase:
PHASE4
Brief Summary
Skeletal muscle loss is a common consequence of aging and in some individuals reaches a level that compromises health and quality of life. Age-associated increases in cytokine and inflammatory signali...
Detailed Description
4 groups of healthy men aged 60 - 85 years were studied over 15 days, in 2 distinct time periods, pre-treatment and treatment. Pre treatment week from study day -7 to study day -1. Treatment week fro...
Eligibility Criteria
Inclusion
- Age: 60-85
- Gender: Male
Exclusion
- Exclusionary medications will be an anticoagulant (Coumadin) because of the risk of bleeding during the biopsy procedure. Additional medications which will be disallowed for participation include: anabolic steroids, nitrates, antihistamines, and glucocorticoids.
- The subjects must be able to successfully complete an exercise stress test using the Bruce protocol . Subjects will be excluded without exercise testing, with a history of angina that occurs with exertion or at rest, or a myocardial infarction within the last 12 months. Subjects that demonstrate ³0.1 milliVolts (mV) horizontal or downsloping ST segment depression, a drop in systolic blood pressure of ³10 mm Hg, and/or frequent or repetitive arrhythmias (defined as ³10 premature ventricular contractions (PVC)/min, or couplets) during the stress test will be excluded.
- Subjects with LDL cholesterol above 200 mg/dL will be excluded .
- Any man with a history of breast cancer or prostate cancer, or any indication of an occult carcinoma from an elevation of prostate specific antigen (PSA) above 4.0 mg/L (53), or severe benign prostatic hypertrophy (BPH) by history (frequent urination, reduced stream) will be excluded.
- Subjects with liver dysfunction evidenced by a history of hepatitis B or hepatitis C, or by a three-fold elevation of liver enzymes (Alk phos, alanine aminotransferase (ALT), aspartate amino-transferase (AST) above normal on screening will be excluded from the study.
- Any subject with a blood pressure on three consecutive measurements taken at one week intervals that has a systolic pressure ³ 140 or a diastolic blood pressure ³ 90 will be excluded.
- Any subject who has a major medical illness such as diabetes, chronic obstructive pulmonary disease, or sleep apnea will be excluded. Moreover, subjects will not have a recent history of smoking tobacco. Morbidly obese older men (BMI \> 35) will also be excluded.
- Subjects will evidence of kidney disease (serum creatinine \> 2.0mg/dl) will be excluded from participation.
- Any subject with thyroid disease as determined by an abnormal thyroid stimulating hormone (TSH) level will be excluded from participation.
- Any subject testing positive for HIV will be excluded .
- Allergy to iodine, a component of Betadine which is used to prepare the subject's skin for invasive procedures, will be cause for exclusion from this study.
- Men with serum total testosterone concentrations greater than 500 ng/dL will be excluded.
- Subjects who engage in high intensity resistance training on a regular basis will be excluded.
- Subjects with a known coagulation disorder or with clinical evidence indicative of a bleeding disorder (easy bruising, "free bleeders") will not be enrolled in this study due to potential problems that could arise from muscle biopsy procedures.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00957801
Start Date
March 1 2009
End Date
December 1 2015
Last Update
May 8 2018
Active Locations (1)
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1
The University of Texas Medical Branch at Galveston
Galveston, Texas, United States, 77555-0567