Testosterone for Men With Insulin Treated Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to test the effect of testosterone treatment on glycaemic control, arterial stiffness and IMT in hypogonadal men with type 2 diabetes treated with insulin.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Testosterone for Peripheral Vascular Disease

NCT00504712

Hypogonadism Peripheral Vascular Disease Type 2 Diabetes

COMPLETED PHASE4

Testosterone Replacement in Diabetes With Vascular Disease (Version 2)

NCT00355537

Diabetes Mellitus Peripheral Vascular Disease

COMPLETED PHASE4

Testosterone Replacement in Men With Diabetes and Obesity

NCT01127659

Hypogonadism

COMPLETED PHASE4

Effect of Increasing Testosterone on Insulin Sensitivity in Men With the Metabolic Syndrome

NCT00438321

Metabolic Syndrome

TERMINATED PHASE1

Effect of Testosterone on Endothelial Function and Microcirculation in Type 2 Diabetic Patients With Hypogonadism

NCT01084369

Type 2 Diabetes Hypogonadism

TERMINATED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

There is epidemiological data linking low serum testosterone levels in men with the development of diabetes. Clinical trials have indicated a potential benefit of testosterone treatment in improving diabetic control and insulin resistance. Type 2 diabetes is also associated with changes in arterial stiffness and IMT which are known to be linked to the presence of cardiovascular disease. Artificially induced hypogonadism results in increasing arterial stiffness whilst testosterone is known to improve risk factors for vascular disease and act as a vasodilator. The purpose of this pilot study is to test the effect of six months of testosterone replacement, given as testosterone esters 200mg from Sustanon 250 IM injection, on diabetes control in hypogonadal men with type 2 diabetes treated with insulin.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypogonadism Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Testosterone

Testosterone injections- 200mg- every 2 weeks

Group Type EXPERIMENTAL

Testosterone

Intervention Type DRUG

Sustanon- 200mg intramuscular testosterone

Placebo

Normal saline injections- every two weeks

Group Type PLACEBO_COMPARATOR

0.9% saline

Intervention Type DRUG

Saline intramuscular injection every two weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Testosterone

Sustanon- 200mg intramuscular testosterone

Intervention Type DRUG

0.9% saline

Saline intramuscular injection every two weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* males over 40 years old
* type 2 diabetes treated with insulin
* serum testosterone less than 12nmol/L on 2 consecutive morning samples
* symptoms attributable to hypogonadism

Exclusion Criteria

* current or previous breast cancer
* current or previous prostate cancer
* raised prostate specific antigen or abdominal digital rectal examination suspicious of prostate cancer unless diagnosis excluded after specialist urology opinion and/or prostate biopsy
* severe symptoms of benign prostatic hypertrophy
* treatment with testosterone in the three months prior to the trial
* investigational drug treatment in the three months prior to the trial

Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes