Anabolic and Inflammatory Responses to Short-Term Testosterone Administration in Older Men

• Register: ClinicalTrials.gov
• Last refreshed on: 22 April 2013
• Main ID: NCT00957801
• Date of registration: 10/08/2009
• Primary sponsor: The University of Texas, Galveston
• Public title: Anabolic and Inflammatory Responses to Short-Term Testosterone Administration in Older Men
• Scientific title: Anabolic and Inflammatory Responses to Short-Term Testosterone Administration in Older Men
• Date of first enrolment: August 2009
• Target sample size: 50
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00957801
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Randall J Urban, M.D.

• Name: Randall J Urban, M.D.

• Name: Randall J Urban, M.D.
• Affiliation: The University of Texas Medical Branch at Galveston

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age: 60-85

- Gender: Male

Exclusion Criteria:

- 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.



Age minimum: 60 Years
Age maximum: 85 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Sarcopenia

Intervention(s)

Drug: Testosterone gel

Drug: Testosterone injection

Primary Outcome(s)

Muscle protein synthesis and breakdown with and without testosterone treatment following resistance exercise [Time Frame: 7 days]

Serum and skeletal muscle cytokine levels and inflammatory signaling will be measured before and after a standardized bout of resistance exercise, both with and without testosterone treatment [Time Frame: 7 days]

Secondary Outcome(s)

Comparison of anabolic response and inflammatory response in muscle treated with injected testosterone versus testosterone gel [Time Frame: 7 days]

Secondary ID(s)

09-070

Source(s) of Monetary Support

Please refer to primary and secondary sponsors