Last Verified: | February/29/2020 |
First Submitted: | March/20/2019 |
Estimated Enrollment Submitted: | March/20/2019 |
First Posted: | March/24/2019 |
Last Update Submitted: | March/2/2020 |
Last Update Posted: | March/3/2020 |
Actual Study Start Date: | September/30/2019 |
Estimated Primary Completion Date: | September/29/2024 |
Estimated Study Completion Date: | September/29/2025 |
Study Type: | Interventional |
Allocation: | Randomized |
: | Double-blind randomized placebo-controlled study comparing the effect of testosterone therapy in men with both type 2 diabetes mellitus and hypogonadism on bone quality, bone turnover markers and circulating osteoblast and osteoclast progenitors. |
Primary Purpose: | Treatment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
: | No other parties will be masked. |
Arm | Intervention/treatment |
---|---|
Experimental: Testosterone arm Testosterone gel 1.62% | Drug: Testosterone arm Testosterone gel 1.62%, apply 2 pumps to upper arm and shoulder. |
Placebo Comparator: Placebo arm Matching placebo will be prepared by the Michael DeBakey VA Medical Center Pharmacy. | Drug: Placebo arm Matching placebo gel, apply 2 pumps to upper arm and shoulder |
Ages Eligible for Study: | 40 Years to 40 Years |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Criteria: | Inclusion Criteria: - Male veterans only - 40 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 <9.5 % - a fasting blood sugar of 180 mg/dl - body mass index (BMI) <35 kg/m2 - with DM of 10 years duration 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 |