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

Phase 3

Completed

• Conditions: Obesity; Low testosterone; Metabolic and Endocrine - Other metabolic disorders; Diet and Nutrition - Obesity

• Registration Number: ACTRN12613000613707
• Lead Sponsor: niversity of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified