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

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.

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Key information

Conditions

Hypogonadism Endocrine System Diseases Gonadal Disorders

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen

Caen, 14000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Estradiol (Insulin sensitivity)

Biological

Testosterone (Insulin sensitivity)

Biological

Primary outcomes

GIR (glucose infusion rate) during euglycemic hyperinsulinemic clamp

Time frame: change between baseline and after 4 weeks of treatments

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Acronym: STEROSENS

Important dates

Study start: 2008
Primary completion: 2015
Study completion: 2016
First posted: Jul 28, 2016
Registry last updated: Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed