Hypogonadism in Young Men With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01155518
• Other study ID #: 1-10-JF-13
• Status: Terminated
• Phase: Phase 2
• Start date: June 2010
• Est. completion date: December 2013

Study information

• Verified date: October 2019
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hypogonadism
• Hypogonadotropic Hypogonadism
• Type 2 Diabetes

Intervention

Drug:
• testosterone
intramuscular every 2 weeks
• clomiphene
thrice a week
• placebo
intramuscular saline injections every 2 weeks
• placebo
oral

Locations

Country	Name	City	State
United States	Millard Fillmore Gates Hospital	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York at Buffalo	American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin Resistance	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.	6 months