Hypogonadism in Young Men With Type 2 Diabetes
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypogonadotropic Hypogonadism Type 2 Diabetes |
Drug: testosterone Drug: clomiphene Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| 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 |
- insulin resistance [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
- inflammation [ Time Frame: 6 months ] [ Designated as safety issue: No ]HH in young T2D men is associated with increased expression and protein content of mediators of inflammation and insulin resistance in MNC, muscle and adipose tissue. Treatment with T and CC decreases inflammation and the expression of proteins that decrease insulin signal transduction.
- body composition [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To compare the total subcutaneous fat mass and lean body mass of T2D men with and without HH as measured by dual energy x-ray absorptiometry (DEXA). Abdominal MRI scan will be carried out to estimate visceral and hepatic fat.
To compare the fat mass and lean body mass after treatment with T or CC for 6 months.
- sexual function and spermatogenesis [ Time Frame: 6 months ] [ Designated as safety issue: No ]HH in young T2D men is associated with a decrease in testicular volume, a decrease in spermatozoal numbers, abnormal spermatozoal morphology and function, decreased sexual function and depressed mood as compared to age matched T2D men without HH and healthy lean controls. T and CC treatment will improve sexual function and mood. CC treatment can increase T concentrations, testicular size and spermatogenesis in T2D men with HH.
| Estimated Enrollment: | 120 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: testosterone
intramuscular injections every 2 weeks
|
Drug: testosterone
intramuscular every 2 weeks
Other Name: testosterone
|
|
Experimental: clomiphene
oral drug thrice a week
|
Drug: clomiphene
thrice a week
Other Name: clomiphene
|
|
Placebo Comparator: placebo for testosterone
placebo for testosterone arm
|
Drug: placebo
intramuscular saline injections every 2 weeks
Other Name: placebo
|
|
Placebo Comparator: placebo for clomiphene
oral placebo for clomiphene arm
|
Drug: placebo
oral
Other Name: placebo
|
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| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- T2D Males with age 18-40 years
Exclusion Criteria:
- planning to have children in the next one year
- Use of androgens, CC, hCG, aromatase inhibitors or over the counter health supplements which contain androgens currently or in the past 6 months;
- PSA > 4ng/ml, symptoms of severe BPH, prostate nodule or severe enlargement on digital rectal examination or h/o prostatic carcinoma
- Hemoglobin A1c > 8%
- Hematocrit > 50%
- History of obstructive sleep apnea
- Congestive heart failure
- Use of thiazolidinediones or exenatide
- currently suffering from depression, with or without treatment
- history of severe depression in the past which needed hospitalization
- currently suffering from foot ulcer, significant periodontal disease or any other chronic infectious condition
- Coronary event or procedure in the previous 6 months
- Hepatic disease (transaminase > 3 times normal) or cirrhosis
- Renal impairment (serum creatinine > 1.5)
- HIV or Hepatitis C positive status
- Participation in any other concurrent clinical trial
Contacts and Locations| Contact: Cathy Gamel | 716-887-4523 | cgamel@kaleidahealth.org |
| Contact: Mehul Vora, MD | (716) 887-5104 | mvora@buffalo.edu |
| United States, New York | |
| Millard Fillmore Gates Hospital | Recruiting |
| Buffalo, New York, United States, 14209 | |
| Contact: Cathy Gamel 716-887-4486 cgamel@kaleidahealth.org | |
| Principal Investigator: Sandeep Dhindsa, MBBS | |
| Principal Investigator: | Sandeep Dhindsa, MBBS | SUNY at Buffalo |
More Information
Additional Information:
No publications provided
| Responsible Party: | Sandeep Dhindsa, State University of New York at Buffalo |
| ClinicalTrials.gov Identifier: | NCT01155518 History of Changes |
| Other Study ID Numbers: | 1-10-JF-13 |
| Study First Received: | June 30, 2010 |
| Last Updated: | July 20, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by State University of New York at Buffalo:
|
hypogonadism diabetes spermatogenesis insulin resistance |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Hypogonadism Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Gonadal Disorders Testosterone Testosterone enanthate Testosterone undecanoate Testosterone 17 beta-cypionate Methyltestosterone Clomiphene Androgens Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anabolic Agents Estrogen Antagonists Estrogen Receptor Modulators Hormone Antagonists Fertility Agents, Female Fertility Agents Reproductive Control Agents Selective Estrogen Receptor Modulators |
ClinicalTrials.gov processed this record on May 21, 2013