Hypogonadism in Young Men With Type 2 Diabetes
| Status: | Terminated |
|---|---|
| Conditions: | Endocrine, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 4/21/2018 |
| Start Date: | June 2010 |
| End Date: | December 2013 |
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
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.
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.
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.
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.
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
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