Effects of Replacement Therapy With Sexual Steroid Hormones on the Insulin Sensitivity of Hypogonadal Man

Phase 3

Completed

• Conditions: Hypogonadism
• Interventions: Biological: Testosterone (Insulin sensitivity); Biological: Estradiol (Insulin sensitivity)

• 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

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2015-08-13
• Primary Completion: 2015-12
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-25
• Study First Posted: 2016-07-28
• Study Completion: 2016-08
• Last Update Submitted: 2018-08-16
• Last Update Posted: 2018-08-17

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

Arm && Interventions

Group	Intervention	Description
Testosterone	Testosterone (Insulin sensitivity)	dosage used : from 25 to 75 mg / day of testosterone (ie 2.5 to 7.5 g / day transdermal gel) according to the plasma level, with the goal of a physiological level of testosterone (5-8 ng / ml) - During 4 weeks
Testosterone + Estradiol	Estradiol (Insulin sensitivity)	Testosterone + Estradiol During 4 weeks
Estradiol	Estradiol (Insulin sensitivity)	dosage used in the study: 1 patch / 3-4 days dosed at 25, 37.5 or 50 mg / 24h titration according to the plasma level, with the objective of a physiological level of estradiol (25-40 pg / ml ) - During 4 weeks
Testosterone + Estradiol	Testosterone (Insulin sensitivity)	Testosterone + Estradiol During 4 weeks

Primary Outcome Measures

Name	Time	Method
GIR (glucose infusion rate) during euglycemic hyperinsulinemic clamp	change between baseline and after 4 weeks of treatments

Trial Locations

Locations (1)

Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen; 🇫🇷 Caen, France