Hypogonadism in Young Men With Type 2 Diabetes

October 3, 2019 updated by: sandeep dhindsa, State University of New York at Buffalo

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14209
        • Millard Fillmore Gates Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: testosterone
intramuscular injections every 2 weeks
Drug: testosterone
intramuscular every 2 weeks
EXPERIMENTAL: clomiphene
oral drug thrice a week
Drug: clomiphene
thrice a week
PLACEBO_COMPARATOR: placebo for testosterone
placebo for testosterone arm
Drug: placebo
oral
Drug: placebo
intramuscular saline injections every 2 weeks
PLACEBO_COMPARATOR: placebo for clomiphene
oral placebo for clomiphene arm
Drug: placebo
oral
Drug: placebo
intramuscular saline injections every 2 weeks
NO_INTERVENTION: eugonadal obese
obese men with normal testosterone level
NO_INTERVENTION: lean
healthy lean men (control)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin Resistance
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York at Buffalo

Collaborators

American Diabetes Association

Investigators

  • Principal Investigator: Sandeep Dhindsa, MBBS, SUNY at Buffalo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

June 30, 2010

First Submitted That Met QC Criteria

June 30, 2010

First Posted (ESTIMATE)

July 1, 2010

Study Record Updates

Last Update Posted (ACTUAL)

October 4, 2019

Last Update Submitted That Met QC Criteria

October 3, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-10-JF-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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