CompletedPhase 3Phase 4ACTRN12613000613707

Effect of Testosterone Therapy Combined with Very Low Caloric Diet on Weight Loss and Weight Maintenance in Obese Men: A Randomized Controlled Trial

Sponsor

University of Melbourne

Enrollment

100 participants

Start Date

Feb 15, 2013

Study Type

Interventional

Conditions

Low testosterone Obesity

Summary

Obesity, an increasing health and economic burden in Australia, is associated with lowered circulating testosterone (T) levels in men. While both dietary restriction and T treatment reduce body fat, whether a combination of these two approaches achieves a more pronounced fat mass reduction is unknown. We will conduct a randomised placebo-controlled trial (RCT) of 12 months T treatment in 100 obese men (defined as body mass index (BMI) > 30kg/m2) with a low T level (defined as serum total T < 12 nmol/L). All men will receive structured dietary intervention to induce and maintain weight loss.

Eligibility

Sex: MalesMin Age: 18 YearssMax Age: 75 Yearss

Inclusion Criteria1

Male sex, age 18-75 years, BMI 30-60 kg/m2and testosterone <12nmol/L

Exclusion Criteria1

established pituitary or testicular disorders, contraindications to testosterone therapy including androgen-dependent carcinoma of the prostate or of the male mammary gland, known malignancy, hypersensitivity to the active substance or to any of the excipients, polycythemia (haematocrit>55%), known liver tumour, significant benign prostate hypertrophy, prostate specific antigen (PSA) > 4ng/ml, uncontrolled hypertension (>160/90 mm Hg despite anti-hypertensive medication, uncontrolled untreated sleep apnoea, severe disturbance in renal function (estimated glomerular filtration rate <30 ml/min), uncontrolled epilepsy, migraine, or significant cardiac insufficiency (New York Heart Association performance status >2), coagulation disorders, current use of weight-altering medications (thiazolidinediones, systemic glucocorticoids, antipsychotics, topiramate), unstable thyroid dysfunction (stable = normal TFT on thyroxine dose >3/12), Cushing’s disease; past history of bariatric surgery

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Interventions

56 weeks Randomised, Placebo-controlled Trial of Testosterone Replacement Therapy in combination with a very low calorie diet Intramuscular testosterone undecanote, 1000mg delivered IM at baseline,

56 weeks Randomised, Placebo-controlled Trial of Testosterone Replacement Therapy in combination with a very low calorie diet Intramuscular testosterone undecanote, 1000mg delivered IM at baseline, week 6, 16, 26, 36 and 46 by study investigators Optifast very low calorie diet administered for the first 8 weeks concurrently with the injections, providing approx 600-700 calories per day. A serve of non-starchy vegetables is encouraged to assist with hunger. Study participants are reviewed every 2 weeks by the doctor when on the very low calorie diet to review compliance and any adverse effects from the diet. These visit take approx 30 minutes. After the very low calorie diet phase, subjects are seen every 10 weeks, these visits take 30 minutes. In addition, visits at baseline, week 10 and week 56 take 3 hours.