Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT03245827 |
Other study ID # |
28389 |
Secondary ID |
|
Status |
Terminated |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
April 1, 2019 |
Est. completion date |
October 29, 2021 |
Study information
Verified date |
June 2022 |
Source |
St. Louis University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Obesity can lead to low testosterone concentrations in young men. This study will study the
effects of low testosterone in those men and the result of treating them with clomiphene.
Description:
The prevalence of obesity has increased in children over the past few decades. Approximately
20% of adolescent boys are now considered obese. It is well accepted that obese children are
at increased risk for high blood pressure, lipid abnormalities and type 2 diabetes. Recent
studies have uncovered yet another undesirable effect of obesity. The testosterone levels of
obese boys are only half those of lean boys at completion of puberty. Testosterone is
important for muscle and bone development. Men with low testosterone are at higher risk of
insulin resistance and inflammation, which lead to type 2 diabetes and heart disease. Since
testosterone is the major reproductive hormone, these obese boys are at risk of decreased
fertility. Men are supposed to achieve their peak testosterone levels at puberty. Thereafter,
there is a decline in testosterone levels at the rate of 2% per year for the rest of life.
Thus there is a clear need to develop a deeper understanding of low testosterone in these
males who are entering their peak fertility years. There are no approved treatments for this
disorder. The investigators propose to conduct a randomized placebo controlled trial to
evaluate the effect of treatment with clomiphene in obese young men(age 18-30 years) who have
low testosterone concentrations. Clomiphene is a drug that increases testosterone
concentrations and possibly increases sperm production. In contrast, testosterone replacement
therapy decreased fertility and cannot be used in young men. Investigators will study the
effect of treatment with clomiphene or placebo tablets for 12 weeks in 30 subjects. The study
will evaluate:-
1. testicular function: Testosterone and two proteins secreted by testis(insulin like
factor 3 and inhibin B) will be measured in the blood before and after treatment with
clomiphene or placebo.
2. insulin resistance: Investigators will measure insulin and glucose levels in the blood.
3. inflammation: Investigators will measure proteins that induce inflammation.