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Effect of Varying Testosterone Levels on Insulin Sensitivity in Men With Idiopathic Hypogonadotropic Hypogonadism (IHH)

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ClinicalTrials.gov Identifier: NCT03118479
Recruitment Status : Terminated (Because the PI left the institution.)
First Posted : April 18, 2017
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Frances Hayes, Massachusetts General Hospital

Study Description
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Brief Summary:

The investigators are doing this research study to look at the relationship between testosterone (the main sex hormone in men) and insulin (the hormone that controls blood sugar levels) in men with Idiopathic Hypogonadotropic Hypogonadism (IHH).

The investigators hypothesize that normalizing testosterone levels in men with IHH enhances insulin sensitivity, reduces visceral fat, increases lean body mass, and improves the lipid profile.


Condition or disease Intervention/treatment Phase
Hypogonadotropic Hypogonadism Kallmann Syndrome Drug: Anastrozole Pill Drug: Testosterone Drug: Placebo Oral Tablet Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Varying Testosterone Levels on Insulin Sensitivity in Men With Idiopathic Hypogonadotropic Hypogonadism
Actual Study Start Date : May 2010
Actual Primary Completion Date : September 1, 2010
Actual Study Completion Date : September 1, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Androgen only addback
Anastrozole 10 mg orally once daily for 3 months Testosterone gel 7.5 g transdermally daily for 3 months.
 Drug: Anastrozole Pill
10 mg of Anastrozole to be taken daily for 3 months.
Other Name: Arimidex (anastrozole)

Drug: Testosterone
Androgel 7.5 g to be applied transdermally daily for 3 months.
Other Name: Androgel
Experimental: Combined sex steroid addback
Placebo (sugar pill) tablet once daily for 3 months Testosterone gel 7.5 g transdermally daily for 3 months.
 Drug: Testosterone
Androgel 7.5 g to be applied transdermally daily for 3 months.
Other Name: Androgel

Drug: Placebo Oral Tablet
One tablet to be taken daily for 3 months


Outcome Measures
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Primary Outcome Measures :
  1. Change in glucose tolerance [ Time Frame: Change between baseline and 3 months ]
    Response to 75 g glucose load

  2. Change in insulin sensitivity [ Time Frame: Change between baseline and 3 months ]
    IV glucose tolerance test


Secondary Outcome Measures :
  1. Change in visceral fat [ Time Frame: Change between baseline and 3 months ]
    Assessed by CT of abdomen

  2. Change in resting energy expenditure [ Time Frame: Change between baseline and 3 months ]
    Assessed by metabolic monitor


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of idiopathic hypogonadotropic hypogonadism or Kallmann Syndrome
  • mean testosterone level less than 300 ng/dl
  • stable weight for the previous 3 months (no weight change greater than or equal to 10 lbs)
  • normal serum TSH
  • normal serum prolactin levels

Exclusion Criteria:

  • Type 2 diabetes mellitus
  • history of diabetes in parents
  • sleep apnea
  • bleeding disorder
  • seeking fertility
  • 2 or more cardiovascular risk factors: smoking, hypertension, diabetes, dyslipidemias, family history of cardiovascular disease before age 60.
  • history of previous cardiovascular event: myocardial infarction, unstable angina, cerebro-vascular accident.
  • illicit drug use/alcohol use (>4 drinks per day)
Contacts and Locations
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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): NCT03118479


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Nelly Pitteloud, MD Massachusetts General Hospital
More Information
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Responsible Party: Frances Hayes, Associate Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03118479    
Other Study ID Numbers: 2009 - P - 001874
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Keywords provided by Frances Hayes, Massachusetts General Hospital:
IHH
KS
Idiopathic hypogonadotropic hypogonadism
GnRH deficiency
Additional relevant MeSH terms:
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Kallmann Syndrome
Insulin Resistance
Hypogonadism
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Gonadal Disorders
Endocrine System Diseases
Disorder of Sex Development, 46,XY
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn
Anastrozole
 Testosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists