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Hypogonadism in Young Men With Type 2 Diabetes

Primary Purpose

Hypogonadotropic Hypogonadism, Type 2 Diabetes

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
testosterone
clomiphene
placebo
placebo
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypogonadotropic Hypogonadism focused on measuring hypogonadism, diabetes, spermatogenesis, insulin resistance

Eligibility Criteria

18 Years - 40 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Millard Fillmore Gates Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

No Intervention

No Intervention

Arm Label

testosterone

clomiphene

placebo for testosterone

placebo for clomiphene

eugonadal obese

lean

Arm Description

intramuscular injections every 2 weeks

oral drug thrice a week

placebo for testosterone arm

oral placebo for clomiphene arm

obese men with normal testosterone level

healthy lean men (control)

Outcomes

Primary Outcome Measures

Insulin Resistance
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

Full Information

First Posted
June 30, 2010
Last Updated
October 3, 2019
Sponsor
State University of New York at Buffalo
Collaborators
American Diabetes Association
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1. Study Identification

Unique Protocol Identification Number
NCT01155518
Brief Title
Hypogonadism in Young Men With Type 2 Diabetes
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 Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
lack of funding
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
Collaborators
American Diabetes Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadotropic Hypogonadism, Type 2 Diabetes
Keywords
hypogonadism, diabetes, spermatogenesis, insulin resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
testosterone
Arm Type
Experimental
Arm Description
intramuscular injections every 2 weeks
Arm Title
clomiphene
Arm Type
Experimental
Arm Description
oral drug thrice a week
Arm Title
placebo for testosterone
Arm Type
Placebo Comparator
Arm Description
placebo for testosterone arm
Arm Title
placebo for clomiphene
Arm Type
Placebo Comparator
Arm Description
oral placebo for clomiphene arm
Arm Title
eugonadal obese
Arm Type
No Intervention
Arm Description
obese men with normal testosterone level
Arm Title
lean
Arm Type
No Intervention
Arm Description
healthy lean men (control)
Intervention Type
Drug
Intervention Name(s)
testosterone
Intervention Description
intramuscular every 2 weeks
Intervention Type
Drug
Intervention Name(s)
clomiphene
Intervention Description
thrice a week
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
intramuscular saline injections every 2 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral
Primary Outcome Measure Information:
Title
Insulin Resistance
Description
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.
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandeep Dhindsa, MBBS
Organizational Affiliation
SUNY at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Millard Fillmore Gates Hospital
City
Buffalo
State/Province
New York
ZIP/Postal Code
14209
Country
United States

12. IPD Sharing Statement

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Hypogonadism in Young Men With Type 2 Diabetes

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