Effect of Varying Testosterone Levels on Insulin Sensitivity in Normal and IHH Men (NCT00470990) | Clinical Trial Compass
CompletedNot Applicable
Effect of Varying Testosterone Levels on Insulin Sensitivity in Normal and IHH Men
United States40 participantsStarted 2002-10
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
insulin sensitivity
Timeframe: 2 timepoints: with a normal serum testsoterone and in a castrate state of low serum testoserone
Trial details
NCT IDNCT00470990
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)