Clinical trial: Testosterone Therapy and Bone Quality in Men With Diabetes and Hypogonadism (NCT03887936)

Eligibility criteria:
Inclusion Criteria:

          -  Male veterans only

          -  35 to 65 years old

          -  With an average fasting morning T level from 2 measurements of <300 ng/dl taken at
             least a day apart

               -  symptoms of hypogonadism as assessed using the androgen deficiency in aging male
                  (ADAM) questionnaire

          -  Participants should have

               -  T2D

               -  an A1C of <10.5 %

               -  a fasting blood sugar of 180 mg/dl

               -  body mass index (BMI) <35 kg/m2

               -  with DM of 15 years duration or less to target men who have relatively less
                  complications from long-term DM

        Exclusion Criteria:

          -  history of prostate or breast cancer

          -  history of testicular disease

          -  untreated severe sleep apnea

          -  ongoing illness that could prevent the subject from completing the study

          -  a hematocrit of >50%

          -  prostate-related findings as:

               -  a palpable prostate nodule on digital rectal exam (DRE)

          -  serum PSA of 4.0 ng/ml

          -  International Prostate Symptom Score (IPSS) >19 (severe)

          -  on androgen therapy or selective androgen receptor modulators

          -  on medications that affect bone metabolism such as:

               -  estrogen

               -  selective estrogen receptor modulator as:

                    -  raloxifene

                    -  aromatase inhibitors

                    -  GnRH analogs

                    -  glucocorticoids with prednisone equivalent of least 5 mg daily for 1 month

                    -  anabolic steroids

                    -  phenobarbital and Dilantin

          -  use of bisphosphonates within two years of study entry, i.e.:

               -  risedronate

               -  alendronate

               -  zoledronic acid

               -  pamidronate

          -  diseases that interfere with bone metabolism, as:

               -  hyperparathyroidism

               -  untreated hyperthyroidism

               -  osteomalacia

               -  chronic liver disease

               -  renal failure

               -  hypercortisolism

               -  malabsorption

               -  immobilization

          -  current alcohol use of > 3 drinks/day

          -  those with a history of:

               -  deep vein thrombosis

               -  pulmonary embolism

               -  stroke or recent diagnosis of coronary artery disease

          -  because of the potential of being randomized to placebo, subjects with osteoporosis or
             a BMD T-score by DXA of -2.5 in the lumbar spine, total femur or femoral neck and
             those with a history of fragility fractures

               -  spine

               -  hip

               -  wrist
Male
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 65 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