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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo for 52 weeks |
|
| Metformin | Experimental | Metformin 850 mg tablets twice daily for 52 weeks |
|
| Testosterone | Experimental | Testosterone Undecanoate 1000 mg/4ml im injection each 12 weeks for 52 weeks |
|
| Metformin + Testosterone | Experimental | Metformin 850 mg tablets twice daily + Testosterone Undecanoate 1000 mg/4ml im injection each 12 weeks for 52 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug |
| ||
| Metformin |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Basal-52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Basal-52 weeks |
| Change in Erectile Dysfunction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Carlos Fernandez-Garcia, MD | Hospital Universitario Virgen de la Victoria. Malaga | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Uiversitario Virgen de la Victoria | Málaga | Malaga | 29010 | Spain |
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| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| D009765 | Obesity |
| D007172 | Erectile Dysfunction |
| D015431 | Weight Loss |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| C010792 | testosterone undecanoate |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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|
|
| Testosterone Undecanoate | Drug |
|
|
| Metformin + Testosterone Undecanoate | Drug |
|
Changes in Erectile Dysfunction will be evaluated with the International Index of Erectile Function (IIEF-5) questionnaire |
| Basal-52 weeks |
| Change in the Aging Male Symptom (AMS) Scale | Change from baseline on the total score of the AMS rating scale | Basal-52 weeks |
| Change in the Androgen Deficiency in the Aging Male (ADAM) Questionnaire | Change from baseline on the ADAM Questionnaire | 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 | 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. | 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) | Basal-52 weeks |
| Change in Metabolic Hormones | Changes in Leptin, adiponectin, betatrophin and kisspeptin levels | Basal-52 weeks |
| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D001836 | Body Weight Changes |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |