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

Mass General Brigham

Status and phase: Terminated; Phase 1

Conditions: Kallmann Syndrome; Hypogonadotropic Hypogonadism

Treatments: Drug: Testosterone; Drug: Anastrozole Pill; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03118479

2009 - P - 001874

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

7 participants in 2 patient groups

Androgen only addback

Experimental group

Description:

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

Treatment:

Drug: Testosterone

Drug: Anastrozole Pill

Combined sex steroid addback

Experimental group

Description:

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

Treatment:

Drug: Placebo Oral Tablet

Drug: Testosterone