Suspended

Clomiphene Citrate and Testosterone Treatment for Young Type 2 Diabetic Men with Hypogonadotropic Hypogonadism

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Study Aim

This phase 2 study aims to compare the insulin sensitivity in young type 2 diabetic men with hypogonadotropic hypogonadism, by measuring whole body glucose uptake during a hyperinsulinemic euglycemic clamp, while undergoing treatment with Clomiphene Citrate and Testosterone.

What is being tested

testosterone

+ clomiphene

+ placebo

Drug
Who is being recruted

Diabetes Mellitus+7

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 18 to 40 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: June 2010
See protocol details

Summary

Principal SponsorState University of New York at Buffalo
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2010

Actual date on which the first participant was enrolled.

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.

Official TitleEffect 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
NCT01155518
Principal SponsorState University of New York at Buffalo
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

5 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesGonadal DisordersHyperinsulinismHypogonadismInsulin ResistanceMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

1 inclusion criteria required to participate
T2D Males with age 18-40 years
16 exclusion criteria prevent from participating
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%
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
intramuscular injections every 2 weeks

Group II

Experimental
oral drug thrice a week

Group III

Placebo
placebo for testosterone arm

Group IV

Placebo
oral placebo for clomiphene arm

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Millard Fillmore Gates Hospital

Buffalo, United StatesOpen Millard Fillmore Gates Hospital in Google Maps
SuspendedOne Study Center