Hypogonadism in Young Men With Type 2 Diabetes
Condition: Hypogonadotropic Hypogonadism; Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2; Hypogonadism
Intervention: testosterone; clomiphene; placebo; placebo
Intervention description: intramuscular every 2 weeks; thrice a week; intramuscular saline injections every 2 weeks; oral
Intervention MeSH terms: Clomiphene; Testosterone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 5.0
Sex: Male
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: hypogonadism; diabetes; spermatogenesis; insulin resistance

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.
    

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