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

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

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.

Study Overview

• Status: Terminated
• Conditions: Kallmann Syndrome; Hypogonadotropic Hypogonadism
• Intervention / Treatment: Drug: Anastrozole Pill; Drug: Testosterone; Drug: Placebo Oral Tablet

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in glucose tolerance	Response to 75 g glucose load	Change between baseline and 3 months
Change in insulin sensitivity	IV glucose tolerance test	Change between baseline and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in visceral fat	Assessed by CT of abdomen	Change between baseline and 3 months
Change in resting energy expenditure	Assessed by metabolic monitor	Change between baseline and 3 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2010
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: July 14, 2010
• First Submitted That Met QC Criteria: April 17, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): April 18, 2017
• Last Update Submitted That Met QC Criteria: April 17, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: GnRH deficiency; IHH; KS; Idiopathic hypogonadotropic hypogonadism
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Gonadal Disorders; Disorders of Sex Development; Urogenital Abnormalities; Congenital Abnormalities; Genetic Diseases, Inborn; Hyperinsulinism; Disorder of Sex Development, 46,XY; Insulin Resistance; Kallmann Syndrome; Hypogonadism; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Androgens; Testosterone; Anastrozole
• Other Study ID Numbers: 2009 - P - 001874

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No