Hypogonadism in Young Men With Type 2 Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by State University of New York at Buffalo.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
American Diabetes Association
Information provided by:
State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT01155518
First received: June 30, 2010
Last updated: July 20, 2011
Last verified: July 2011
  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

Resource links provided by NLM:


Further study details as provided by State University of New York at Buffalo:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01155518

Contacts
Contact: Cathy Gamel 716-887-4523 cgamel@kaleidahealth.org
Contact: Mehul Vora, MD (716) 887-5104 mvora@buffalo.edu

Locations
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         
Sponsors and Collaborators
State University of New York at Buffalo
American Diabetes Association
Investigators
Principal Investigator: Sandeep Dhindsa, MBBS SUNY at Buffalo
  More 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 April 15, 2014