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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT03118479
Collaborator
(none)
7
Enrollment
1
Location
2
Arms
4
Actual Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 1, 2010
Actual Primary Completion Date :
Sep 1, 2010
Actual Study Completion Date :
Sep 1, 2010

Arms and Interventions

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 Names:
  • Arimidex (anastrozole)

    • Drug: Testosterone
    Androgel 7.5 g to be applied transdermally daily for 3 months.
    Other Names:
  • 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 Names:
  • Androgel

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

    Outcome Measures

    Primary Outcome Measures

    1. Change in glucose tolerance [Change between baseline and 3 months]

      Response to 75 g glucose load

    2. Change in insulin sensitivity [Change between baseline and 3 months]

      IV glucose tolerance test

    Secondary Outcome Measures

    1. Change in visceral fat [Change between baseline and 3 months]

      Assessed by CT of abdomen

    2. Change in resting energy expenditure [Change between baseline and 3 months]

      Assessed by metabolic monitor

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Massachusetts General Hospital

    Investigators

    • Principal Investigator: Nelly Pitteloud, MD, Massachusetts General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Frances Hayes, Associate Professor, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT03118479
    Other Study ID Numbers:
    • 2009 - P - 001874
    First Posted:
    Apr 18, 2017
    Last Update Posted:
    Apr 18, 2017
    Last Verified:
    Apr 1, 2017
    Keywords provided by Frances Hayes, Associate Professor, Massachusetts General Hospital
    IHH
    KS
    Idiopathic hypogonadotropic hypogonadism
    GnRH deficiency
    Additional relevant MeSH terms:
    Kallmann Syndrome
    Insulin Resistance
    Hypogonadism
    Anastrozole
    Testosterone

    Study Results

    No Results Posted as of Apr 18, 2017