Suspended

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

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Study AimThis 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
+4

+ Diabetes Mellitus, Type 2
+ Endocrine System Diseases
From 18 to 40 Years
See all eligibility criteria
How is the trial designed

Treatment Study

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

Summary

Principal SponsorState University of New York at Buffalo
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2010Actual 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 18, 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants do not know which treatment they are receiving, but researchers do. This helps prevent bias from participants' expectations while still allowing researchers to monitor the study closely.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
MaleBiological sex of participants that are eligible to enroll.
From 18 to 40 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Gonadal Disorders
Hypogonadism
Metabolic Diseases
Glucose Metabolism Disorders
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

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

intramuscular every 2 weeks
Group II
Experimental
oral drug thrice a week

thrice a week
Group III
Placebo
placebo for testosterone arm

intramuscular saline injections every 2 weeks
Group IV
Placebo
oral placebo for clomiphene arm

intramuscular saline injections every 2 weeks
Study Objectives
Primary Objectives

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.

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 HospitalBuffalo, United StatesSee the location
SuspendedOne Study Center
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