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NCT01155518 · ClinicalTrials.gov registry record · Phase 2
Hypogonadism in Young Men With Type 2 Diabetes
A Phase 2 study, sponsored by State University of New York at Buffalo.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT01155518: Clinical Trial Phase 2 study, sponsored by State University of New York at Buffalo.
NCT01155518 is a Phase 2 study that was terminated before completion, run by State University of New York at Buffalo. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01155518, a Phase 2 study, was terminated before completion, sponsored by State University of New York at Buffalo.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
Low testosterone production, known clinically as hypogonadism, appears to be common complication of type 2 diabetes, affecting one in three diabetic men. Hypogonadism is known to be associated with decreased muscle mass, increased fat mass, increased inflammation and decreased fertility. In this grant, the investigators propose to study the effects of having low testosterone on 1) insulin sensitivity, the ability of the body to handle glucose 2) fat and muscle mass at specific areas of the body 3) expression of mediators of inflammation in the blood 4) semen quality. This study will compare diabetic men (with or without hypogonadism). This study will also evaluate the effect of treatment with clomiphene (a drug that increases testosterone and sperm production) or testosterone in men with diabetes and hypogonadism. The investigators hope that this project will help us understand the state of hypogonadism in young type 2 diabetic men who are in their peak fertility years and give us insights into treatment of this condition. With the rising prevalence of type 2 diabetes in the young, this project may have implications for public health.
Primary Outcome
To compare the insulin sensitivity as measured by whole body glucose uptake during hyperinsulinemic euglycemic (HE) clamp in young T2D men with and without HH.
Interventions
- DRUG placebo
- DRUG testosterone
- DRUG clomiphene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2010-06 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
Why NCT01155518 stopped before completion
NCT01155518 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT01155518 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01155518 about?
NCT01155518 is a clinical study titled "Hypogonadism in Young Men With Type 2 Diabetes". Low testosterone production, known clinically as hypogonadism, appears to be common complication of type 2 diabetes, affecting one in three diabetic men. Hypogonadism is known to be associated with decreased muscle mass, increased fat mass, increased inflammation and decreased fertility. In this gra...
What is the current status of trial NCT01155518?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2010-06. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01155518?
The interventions under investigation include: placebo (DRUG), testosterone (DRUG), clomiphene (DRUG).
Who is sponsoring clinical trial NCT01155518?
This trial is sponsored by State University of New York at Buffalo, which has 243 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01155518's enrollment target sits among peer trials
5 2000th of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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