Testosterone Therapy and Bone Quality in Men With Diabetes and Hypogonadism
Type 2 Diabetes Mellitus, Hypogonadism
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring diabetes mellitus, hypogonadism, testosterone, bone quality
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
Sites / Locations
- Michael E. DeBakey VA Medical Center, Houston, TXRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Testosterone arm
Placebo arm
Testosterone gel 1.62%
Matching placebo will be prepared by the Michael DeBakey VA Medical Center Pharmacy.