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Hypogonadism in Young Men With Type 2 Diabetes

Information source: State University of New York at Buffalo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypogonadotropic Hypogonadism; Type 2 Diabetes

Intervention: testosterone (Drug); clomiphene (Drug); placebo (Drug); placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: State University of New York at Buffalo

Official(s) and/or principal investigator(s):
Sandeep Dhindsa, MBBS, Principal Investigator, Affiliation: SUNY at Buffalo

Overall contact:
Cathy Gamel, Phone: 716-887-4523, Email: cgamel@kaleidahealth.org

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: insulin resistance

Secondary outcome:

inflammation

body composition

sexual function and spermatogenesis

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

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Male.

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

Locations and Contacts

Cathy Gamel, Phone: 716-887-4523, Email: cgamel@kaleidahealth.org

Millard Fillmore Gates Hospital, Buffalo, New York 14209, United States; Recruiting
Cathy Gamel, Phone: 716-887-4486, Email: cgamel@kaleidahealth.org
Sandeep Dhindsa, MBBS, Principal Investigator
Additional Information

Starting date: June 2010
Last updated: July 20, 2011

Page last updated: August 23, 2015

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