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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

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:

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

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

Placebo Comparator

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

NCT ID

NCT01155518

First Posted

June 30, 2010

Last Updated

October 3, 2019

Sponsor

State University of New York at Buffalo

Collaborators

American Diabetes Association

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

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

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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