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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03118479

Enrollment

Registered

2017-04-18

Start date

2010-05-31

Completion date

2010-09-01

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypogonadotropic Hypogonadism, Kallmann Syndrome

Keywords

IHH, KS, Idiopathic hypogonadotropic hypogonadism, GnRH deficiency

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.

Interventions

DRUGAnastrozole Pill

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

DRUGTestosterone

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

DRUGPlacebo Oral Tablet

One tablet to be taken daily for 3 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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)

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026