Effect of metformin and clomiphene in obese hypogonadal men with or without type 2 diabetes on plasma levels of testosterone and metabolic parameters

• Conditions: obese subjects with type 2 diabetes and hypogonadism; MedDRA version: 14.1Level: LLTClassification code 10049746Term: Insulin-requiring type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.1Level: PTClassification code 10033307Term: OverweightSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]; MedDRA version: 14.1Level: PTClassification code 10021011Term: Hypogonadism maleSystem Organ Class: 10014698 - Endocrine disorders

• Registration Number: EUCTR2011-000439-10-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-29
• Last Update Posted: 24 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

males aged between 35 and 55 years
• Obesity, defined according to the WHO criteria for body mass index (BMI)superior to 30 kg/m2
• diagnosis of diabetes or impaired glucose tolerance according to the criteria defined by the American Diabetes Association (ADA) in 2009: in particular will be considered to have impaired glucose tolerance subjects with glucose at the second hour after oral glucose tolerance test (OGTT ) between 140 and 199 mg /dl, and diabetic subjects with fasting glucose superior to 126 mg /dl or blood glucose at the second hour after oral glucose tolerance test (OGTT)superior to 200 mg /dl
• HbA1c inferior to 8.5%
• metabolic syndrome, defined according to ATP III guidelines, or to the simultaneous presence of three or more of the following disorders: central obesity (waist circumference superior/egual to 102 cm), hypertension (SBP superior/egual to 130 mmHg or DBP superior/egual to 85 mmHg or pharmacological therapy for hypertension), hypertriglyceridemia (superior/egual to 150 mg /dl or pharmacological therapy hypertriglyceridemia), low HDL cholesterol (inferior to 40 mg /dl or pharmacological therapy for low HDL cholesterol
• hypogonadism, defined for circulating levels of total testosterone inferior/egual to 3 ng /ml
• signature of informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Patients with primary or secondary hypogonadism associated with genetic diseases or infiltrative or destructive disease of endocrine organs (testis, hypothalamus-pituitary)
• Patients on oral hypoglycemic agents treatment or in the 3 months preceding the start of the study
• Patients on lipid-lowering drug therapy or in the 3 months preceding the start of the study
• Known or suspected hypersensitivity to the drug or drug class in the study;
• Patients with serious medical conditions that, in the opinion of the investigator, contraindicate the patient's participation in the study;
• Use of systemic experimental drugs in the last 3 months before inclusion in the study.
• Patients unable to follow the procedures of the Protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified