obese subjects with type 2 diabetes and hypogonadism MedDRA version: 14.1 Level: LLT Classification code 10049746 Term: Insulin-requiring type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 14.1 Level: PT Classification code 10021011 Term: Hypogonadism male System Organ Class: 10014698 - Endocrine disorders MedDRA version: 14.1 Level: PT Classification code 10033307 Term: Overweight System Organ Class: 10027433 - Metabolism and nutritio
Conditions
Interventions
Trade Name: SEROFENE*30CPR 50MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: CLOMIFENE CITRATE
CAS Number: 50-41-9
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: evaluate the effect of the therapy with metformin and clomiphene citrate on plasma levels of testosterone in obese subjects with type 2 diabetes or glucose intolerance, and hypogonadism;Secondary Objective: evaluate the effect of the therapy with metformin and clomiphene citrate on: • metabolic parameters (plasma glucose, HbA1c, insulin and C-peptide, HOMA-IR, free fatty acids (FFA), total cholesterol, HDL, LDL, triglycerides); • circulating levels of markers of chronic inflammation (fibrinogen, CRP) and inflammatory cytokines (TNF-a, IL-6); • on the plasma levels of hormones secreted by adipose tissue (adiponectin, leptin); • on the plasma levels of endocannabinoids.;Primary end point(s): The primary goal of the study is to evaluate the effect of metformin and clomiphene on plasma levels of testosterone.;Timepoint(s) of evaluation of this end point: 30 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): evaluate the effect of the therapy with metformin and clomiphene citrate on: • metabolic parameters (plasma glucose, HbA1c, insulin and C-peptide, HOMA-IR, free fatty acids (FFA), total cholesterol, HDL, LDL, triglycerides); • circulating levels of markers of chronic inflammation (fibrinogen, CRP) and inflammatory cytokines (TNF-a, IL-6); • on the plasma levels of hormones secreted by adipose tissue (adiponectin, leptin); • on the plasma levels of endocannabinoids.;Timepoint(s) of evaluation of this end point: 30 weeks | — |
Countries
Italy
Contacts
Public ContactU.O. Endocrinologia - Prof.Pasquali
AOU di Bologna
Outcome results
None listed