Effects of Replacement Therapy With Sexual Steroid Hormones on the Insulin Sensitivity of Hypogonadal Man
Phase 3
Completed
- Conditions
- Hypogonadism
- Registration Number
- NCT02847806
- Lead Sponsor
- University Hospital, Caen
- Brief Summary
Sexual steroids administered to supra-physiological doses are likely to change the carbohydrate and lipid metabolism.
Investigators propose to study in 12 hypogonadal men hypogonadotropic or hypergonadotropic treated with aromatase inhibitor, the respective effects of estradiol, testosterone or both steroids administered in a cross-over Latin squares plan on insulin sensitivity measured by the reference method of the hyperinsulinemic euglycemic clamp.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
Inclusion Criteria
- Hypogonadism hypogonadotropic or hypergonadotropic
- Man aged 18-60 years
- BMI between 18 and 27.
Exclusion Criteria
- Other ante-pituitary deficiency
- Chronic treatment modifying carbohydrate metabolism (thiazides, beta 2 mimetics, steroids ...)
- Diabetes
- Obesity diffuse or android
- Hemochromatosis
- osteoporosis
- chronic diseases
- neoplasia
- High blood pressure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method GIR (glucose infusion rate) during euglycemic hyperinsulinemic clamp change between baseline and after 4 weeks of treatments
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen
🇫🇷Caen, France
Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen🇫🇷Caen, France