Testosterone for Men With Insulin Treated Type 2 Diabetes

March 29, 2010 updated by: Barnsley Hospital

A Randomised Double Blind Placebo Controlled, Parallel Pilot Study to Test the Effect of Testosterone Replacement on Glycaemic Control and Arterial Wall Properties of Hypogonadal Men With Type 2 Diabetes Treated With Insulin

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • South Yorkshire
      • Barnsley, South Yorkshire, United Kingdom, S75 2EP
        • Barnsley Hospital NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Testosterone
Testosterone injections- 200mg- every 2 weeks
Drug: Testosterone
Sustanon- 200mg intramuscular testosterone
PLACEBO_COMPARATOR: Placebo
Normal saline injections- every two weeks
Drug: 0.9% saline
Saline intramuscular injection every two weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The effect of 6 months of testosterone replacement on diabetes control measured by HbA1c in hypogonadal men with type 2 diabetes treated with insulin.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The effect of testosterone on ultrasound measured intima-media thickness of the common carotid artery in the study population
Time Frame: 6 months
6 months
The effect of testosterone on male hypogonadism as assessed by the Ageing Males Symptoms (AMS)
Time Frame: 6 months
6 months
The effect of testosterone on markers of vascular risk; blood pressure, serum lipid levels, weight, waist circumference, body fat percentage,
Time Frame: 6 months
6 months
urinary micro-albumin, tumour necrosis factor alpha, and highly sensitive C reactive protein levels in the study population.
Time Frame: 6 months
6 months
The effect of the CAG repeat polymorphism in exon 1 of the androgen receptor gene on the response of the study population to testosterone.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barnsley Hospital

Investigators

  • Principal Investigator: Hugh Jones, BSc MD FRCP, Barnsley Hospital NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (ACTUAL)

October 1, 2008

Study Completion (ACTUAL)

October 1, 2008

Study Registration Dates

First Submitted

July 6, 2006

First Submitted That Met QC Criteria

July 6, 2006

First Posted (ESTIMATE)

July 7, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

March 30, 2010

Last Update Submitted That Met QC Criteria

March 29, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BDGH 264

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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