Clinical trial NCT01155518: Hypogonadism in Young Men With Type 2 Diabetes
Official title: Effect of Hypogonadotropic Hypogonadism and Replacement With Clomiphene Citrate and Testosterone on Insulin Sensitivity, Body Composition, Inflammation, Sexual Function and Spermatogenesis in Young Type 2 Diabetic Men
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hypogonadotropic Hypogonadism
Type 2 Diabetes
Keywords: hypogonadism
diabetes
spermatogenesis
insulin resistance
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2010-07-01
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This project will study young men with type 2 diabetes. We have shown that half of these men have low testosterone levels. This can lead to 1) Low muscle mass; 2) more fat mass; 3) insulin resistance; 4) low sperm count and 5) increased inflammation (that increases the risk of heart disease). This project will study these consequences in detail and also the possibility of reversing them with treatment. Information from this project will be useful in planning of future studies that will evaluate the effect of treatment of low testosterone on mortality, heart disease and stroke.

Eligibility criteria: Inclusion Criteria:

* T2D Males with age 18-40 years

Exclusion Criteria:

1. planning to have children in the next one year
2. Use of androgens, CC, hCG, aromatase inhibitors or over the counter health supplements which contain androgens currently or in the past 6 months;
3. PSA \> 4ng/ml, symptoms of severe BPH, prostate nodule or severe enlargement on digital rectal examination or h/o prostatic carcinoma
4. Hemoglobin A1c \> 8%
5. Hematocrit \> 50%
6. History of obstructive sleep apnea
7. Congestive heart failure
8. Use of thiazolidinediones or exenatide
9. currently suffering from depression, with or without treatment
10. history of severe depression in the past which needed hospitalization
11. currently suffering from foot ulcer, significant periodontal disease or any other chronic infectious condition
12. Coronary event or procedure in the previous 6 months
13. Hepatic disease (transaminase \> 3 times normal) or cirrhosis
14. Renal impairment (serum creatinine \> 1.5)
15. HIV or Hepatitis C positive status
16. Participation in any other concurrent clinical trial

Primary outcomes:
measure: Insulin Resistance
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Millard Fillmore Gates Hospital
state: New York
Study officials:
affiliation: SUNY at Buffalo
name: Sandeep Dhindsa, MBBS
role: PRINCIPAL_INVESTIGATOR
References: