Clinical trial: HORMA: Hormonal Regulators of Muscle and Metabolism in Aging (NCT00183040)

Eligibility criteria:
Inclusion Criteria:

          -  Men who are 65-90 years of age

          -  Total serum IGF-1 (insulin-like growth factor) in the lower tertile for adults (56-167
             ug/dl)

          -  Total serum testosterone of 150-550 ng/dL

        Exclusion Criteria:

          -  BMI (Body Mass Index) 35 kg/m2 or greater

          -  Weight instability (>3% change in prior 3 months)

          -  Daily intake of total kilocalories less than or equal to 0.8X the RDA and intake of
             protein between 0.8 and 1.4 g/kg/day inclusive

          -  Acute illness in the prior 30 days

          -  Resistance training (wt lifting) in the past 12 months

          -  Vigorous aerobic sports (Competing as a Master athlete in the prior 5 years; weekly
             swimming, racquet ball, cycling, tennis, in preceding 12 months)

          -  Use of an anabolic agent (androgen, androgen precursor, rhGH, etc) in the preceding 12
             months

          -  Use of medications that might affect amino acid metabolism (e.g. beta-adrenergic
             blockers, beta-agonists, Ca2+ channel blockers, corticosteroids)

          -  Fasting sugar greater than or equal to 126 mg/dl or diabetes requiring Rx

          -  History of benign intracranial hypertension

          -  Heart failure, active angina, or myocardial infarction in the prior 6 months or
             history of aortic stenosis

          -  Uncontrolled hypothyroidism or hyperthyroidism

          -  Rheumatoid arthritis, cirrhosis or active hepatitis

          -  History of carpal tunnel syndrome

          -  Prior cancer other than squamous or basal cell carcinoma of the skin

          -  Sleep apnea or severe chronic lung disease

          -  Anticoagulation with heparin or coumadin

          -  Blood pressure not controlled with medication to <180/95 mm Hg

          -  Calculated creatinine clearance <50 cc/min

          -  Serum prostatic antigen >4.0 or American Urological Association score greater than or
             equal to 8

          -  Hematocrit greater than or equal 52%, or ALT >1.5X ULN

          -  Failure to pass a modified Bruce treadmill stress test

          -  Severe disability limiting strength or physical function testing

          -  Dementia or cognitive impairment affecting a subject's ability to provide informed
             consent
Male
No healthy subjects accepted to join the trial.
Subject must be at least 65 Years old.
Subject must be at most 90 Years

Patient description (medical language): A 19-year-old male came to clinic with some sexual concern.  He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates.  On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH.

Patient description (patient's own words): I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels.

Does the patient match the trial criteria? Contradiction