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

Primary Purpose

Hypogonadotropic Hypogonadism, Kallmann Syndrome

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Anastrozole Pill
Testosterone
Placebo Oral Tablet
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypogonadotropic Hypogonadism focused on measuring IHH, KS, Idiopathic hypogonadotropic hypogonadism, GnRH deficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Androgen only addback

Combined sex steroid addback

Arm Description

Anastrozole 10 mg orally once daily for 3 months Testosterone gel 7.5 g transdermally daily for 3 months.

Placebo (sugar pill) tablet once daily for 3 months Testosterone gel 7.5 g transdermally daily for 3 months.

Outcomes

Primary Outcome Measures

Change in glucose tolerance
Response to 75 g glucose load
Change in insulin sensitivity
IV glucose tolerance test

Secondary Outcome Measures

Change in visceral fat
Assessed by CT of abdomen
Change in resting energy expenditure
Assessed by metabolic monitor

Full Information

First Posted
July 14, 2010
Last Updated
April 17, 2017
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03118479
Brief Title
Effect of Varying Testosterone Levels on Insulin Sensitivity in Men With Idiopathic Hypogonadotropic Hypogonadism (IHH)
Official Title
Effect of Varying Testosterone Levels on Insulin Sensitivity in Men With Idiopathic Hypogonadotropic Hypogonadism
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Because the PI left the institution.
Study Start Date
May 2010 (Actual)
Primary Completion Date
September 1, 2010 (Actual)
Study Completion Date
September 1, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadotropic Hypogonadism, Kallmann Syndrome
Keywords
IHH, KS, Idiopathic hypogonadotropic hypogonadism, GnRH deficiency

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Androgen only addback
Arm Type
Experimental
Arm Description
Anastrozole 10 mg orally once daily for 3 months Testosterone gel 7.5 g transdermally daily for 3 months.
Arm Title
Combined sex steroid addback
Arm Type
Experimental
Arm Description
Placebo (sugar pill) tablet once daily for 3 months Testosterone gel 7.5 g transdermally daily for 3 months.
Intervention Type
Drug
Intervention Name(s)
Anastrozole Pill
Other Intervention Name(s)
Arimidex (anastrozole)
Intervention Description
10 mg of Anastrozole to be taken daily for 3 months.
Intervention Type
Drug
Intervention Name(s)
Testosterone
Other Intervention Name(s)
Androgel
Intervention Description
Androgel 7.5 g to be applied transdermally daily for 3 months.
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
One tablet to be taken daily for 3 months
Primary Outcome Measure Information:
Title
Change in glucose tolerance
Description
Response to 75 g glucose load
Time Frame
Change between baseline and 3 months
Title
Change in insulin sensitivity
Description
IV glucose tolerance test
Time Frame
Change between baseline and 3 months
Secondary Outcome Measure Information:
Title
Change in visceral fat
Description
Assessed by CT of abdomen
Time Frame
Change between baseline and 3 months
Title
Change in resting energy expenditure
Description
Assessed by metabolic monitor
Time Frame
Change between baseline and 3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nelly Pitteloud, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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