Hypogonadotropic Hypogonadism in Obese Young Males

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    90
  • sponsor
    Sandeep Singh Dhindsa, M.D., F.A.C.E
Updated on 26 January 2021
testosterone
testosterone level
clomiphene
klinefelter syndrome
secondary hypogonadism

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.

Details
Condition Hypogonadism, Klinefelter's Syndrome
Treatment Placebo, Clomiphene
Clinical Study IdentifierNCT03245827
SponsorSandeep Singh Dhindsa, M.D., F.A.C.E
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 30 yrs?
Are you male?
Do you have any of these conditions: Hypogonadism or Klinefelter's Syndrome?
Do you have any of these conditions: Klinefelter's Syndrome or Hypogonadism?
Males
Age 18-30 years inclusive will be recruited
A total of 90 males will be recruited:-
obese males (defined as BMI 30 kg/m2) with HH
obese males with normal FT concentrations and
lean males (defined as BMI <25 kg/m2) with normal FT concentrations

Exclusion Criteria

Use of androgens, clomiphene, hCG, aromatase inhibitors or over the counter health supplements which contain androgens currently or in the past 6 months
Hematocrit > 50%
Congestive heart failure
currently suffering from depression
type 1 diabetes
Hepatic disease (transaminase > 3 times normal) or cirrhosis
Renal impairment (eGFR<30 ml/min/1.73m2)
HIV or Hepatitis C positive status
Participation in any other concurrent clinical trial
currently suffering from foot ulcer, significant periodontal disease or any other chronic infectious condition
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note