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

NCT03118479 | Terminated Phase 1 DMC

• 1 other identifier: 2009 - P - 001874
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypogonadotropic Hypogonadism; Kallmann Syndrome

Keywords

IHH; KS; Idiopathic hypogonadotropic hypogonadism; GnRH deficiency

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in visceral fat

  Change between baseline and 3 months

• Change in resting energy expenditure

  Change between baseline and 3 months

Study Arms (2)

Androgen only addback

EXPERIMENTAL

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

Drug: Anastrozole Pill; Drug: Testosterone

Combined sex steroid addback

EXPERIMENTAL

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

Drug: Testosterone; Drug: Placebo Oral Tablet

Interventions

Anastrozole Pill DRUG

10 mg of Anastrozole to be taken daily for 3 months.

Also known as: Arimidex (anastrozole)

Androgen only addback

Testosterone DRUG

Androgel 7.5 g to be applied transdermally daily for 3 months.

Also known as: Androgel

Androgen only addback; Combined sex steroid addback

Placebo Oral Tablet DRUG

One tablet to be taken daily for 3 months

Combined sex steroid addback

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Type 2 diabetes mellitus
• history of diabetes in parents
• sleep apnea
• bleeding disorder
• seeking fertility
• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Hypogonadism; Kallmann Syndrome; Idiopathic Hypogonadotropic Hypogonadism

Interventions

Anastrozole; Testosterone

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Disorder of Sex Development, 46,XY; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Nelly Pitteloud, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: April 18, 2017
• Study Start: May 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: April 18, 2017

Record last verified: 2017-04

Locations

US (1)