Clinical trial NCT00470990: Effect of Varying Testosterone Levels on Insulin Sensitivity in Normal and IHH Men
Official title: Effect of Varying Testosterone Levels on Insulin Sensitivity in Normal and IHH Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypogonadism
Keywords: IHH
Kallmann syndrome
hypogonadism
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: American Diabetes Association
First posted: 2007-05-08
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER

Brief summary: Type 2 diabetes is one of the most common metabolic disorders in the U.S, estimated to affect 16 million Americans. Established risk factors for this disease include obesity, increased waist/hip ratio, high insulin levels in the blood, and insulin resistance. Testosterone may play a role in developing or preventing diabetes, but we do not yet know for sure. The purpose of this research study is to determine if changing testosterone levels in men will result in changes in insulin sensitivity. Information learned form this research study may have important public health implications and may point to new strategies for treating or preventing diabetes.

Detailed description: The overall aim of this study is to examine the effect of testosterone on insulin sensitivity using the models of acute and chronic hypogonadism. All subjects will be in good general health and 2 groups of men will be studied in this protocol:

1. Thirty healthy normal men aged 18-75 years with normal blood pressure, normal testosterone levels, and not taking any medications known to influence glucose homeostasis or testosterone
2. Ten adult men (over the age of 18) with idiopathic hypogonadotropic hypogonadism (IHH)and normal thyroid, adrenal, and growth hormone axes as well as normal prolactin levels and no abnormalities on imaging of the hypothalamic-pituitary region. These men will be on no medications known to influence glucose homeostasis and will have been off hormone therapy for a suitable washout period depending on the type of prior androgen replacement.

Eligibility criteria: Inclusion Criteria:

Healthy men:

Good general health,

* Normotensive,
* Normal testosterone levels,
* No medications known to influence glucose homeostasis or testosterone levels

IHH men:

* Good general health;
* Normal thyroid, adrenal, and GH axes;
* Normal prolactin levels;
* No abnormalities on imaging of the hypothalamic-pituitary region;
* No medications known to influence glucose homeostasis;
* Must have been off hormone therapy for a suitable washout period depending on the type of prior androgen replacement

Primary outcomes:
measure: insulin sensitivity
timeFrame: 2 timepoints: with a normal serum testsoterone and in a castrate state of low serum testoserone
Secondary outcomes:
measure: body composition
timeFrame: 2 timepoints: with a normal serum testsoterone and in a castrate state of low serum testoserone
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Frances J Hayes, MD
role: PRINCIPAL_INVESTIGATOR
References: