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

• Sponsor: University Hospital, Caen (Other)
• Overall Status: Completed
• CT.gov ID: NCT02847806
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arms: 3
• Duration (Months): 103
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypogonadism	Biological: Estradiol (Insulin sensitivity); Biological: Testosterone (Insulin sensitivity)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Estradiol 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	Biological: Estradiol (Insulin sensitivity)
Experimental: Testosterone 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	Biological: Testosterone (Insulin sensitivity)
Experimental: Testosterone + Estradiol Testosterone + Estradiol During 4 weeks	Biological: Estradiol (Insulin sensitivity); Biological: Testosterone (Insulin sensitivity)

Outcome Measures

Primary Outcome Measures

1. GIR (glucose infusion rate) during euglycemic hyperinsulinemic clamp [change between baseline and after 4 weeks of treatments]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen	Caen		France	14000

Sponsors and Collaborators

• University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Caen
• ClinicalTrials.gov Identifier: NCT02847806
• Other Study ID Numbers: 07-034
• First Posted: Jul 28, 2016
• Last Update Posted: Aug 17, 2018
• Last Verified: Jul 1, 2016

• Additional relevant MeSH terms: Hypogonadism; Insulin; Insulin, Globin Zinc; Estradiol; Testosterone

Study Results

No Results Posted as of Aug 17, 2018