The purpose of this study is to examine the effects of metformin, testosterone, or both, in males with obesity-related hypogonadism. This study will evaluate changes in insulin resistance, weight loss, body composition, testosterone levels,quality of life and erectile dysfunction. Obese men will receive diet and physical activity counselling, and be randomised to either testosterone, metformin, a combination of both or placebo
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
107
Hospital Uiversitario Virgen de la Victoria
Málaga, Malaga, Spain
Change in Insulin Resistance
Insulin resistance will be measured using Homeostasis Model of Assessment for Insulin Resistance index (HOMA-IR index) HOMA-IR=FINS\*FGLU/22.5
Time frame: Basal-52 weeks
Change in Body Weight
Body weight will be measured on a Tanita Multi-Frequency Body Composition Analyzer MC-180MA (Tanita Corporation, Tokyo, Japan) to assess change in body weight over the 52-week intervention period.
Time frame: Basal-52 weeks
Change in Erectile Dysfunction
Changes in Erectile Dysfunction will be evaluated with the International Index of Erectile Function (IIEF-5) questionnaire
Time frame: Basal-52 weeks
Change in the Aging Male Symptom (AMS) Scale
Change from baseline on the total score of the AMS rating scale
Time frame: Basal-52 weeks
Change in the Androgen Deficiency in the Aging Male (ADAM) Questionnaire
Change from baseline on the ADAM Questionnaire
Time frame: Basal-52 weeks
Change in Testosterone Levels (Total and Free)
The change from baseline to week 52 in free testosterone and total testosterone levels will be assessed
Time frame: Basal-52 weeks
Change in Body Composition (Fat and Lean Mass)
Body Composition will be measured on a Tanita Multi-Frequency Body Composition Analyzer MC-180MA (Tanita Corporation, Tokyo, Japan) to assess changes in body composition (fat mass, lean mass, total body water) over the 52-week intervention period.
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Time frame: Basal-52 weeks
Change in Biochemical Markers of Bone Turnover
Change in Bone turnover, measured by serum procollagen type I N-terminal propeptide (PINP) and Beta-CrossLaps (β-CTx)
Time frame: Basal-52 weeks
Change in Metabolic Hormones
Changes in Leptin, adiponectin, betatrophin and kisspeptin levels
Time frame: Basal-52 weeks