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

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ClinicalTrials.gov Identifier: NCT02847806
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Hypogonadism Biological: Estradiol (Insulin sensitivity) Biological: Testosterone (Insulin sensitivity) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2008
Actual Primary Completion Date : December 2015
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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)



Primary Outcome Measures :
  1. GIR (glucose infusion rate) during euglycemic hyperinsulinemic clamp [ Time Frame: change between baseline and after 4 weeks of treatments ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02847806


Locations
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France
Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen
Caen, France, 14000
Sponsors and Collaborators
University Hospital, Caen

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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02847806     History of Changes
Other Study ID Numbers: 07-034
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: July 2016

Additional relevant MeSH terms:
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Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Methyltestosterone
Estradiol
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Hypoglycemic Agents
Physiological Effects of Drugs
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Estrogens
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female