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Completed

NCT Number: NCT00349362

Testosterone for Men With Insulin Treated Type 2 Diabetes

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.

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Key information

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Barnsley Hospital NHS Foundation Trust

Barnsley, South Yorkshire, S75 2EP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Testosterone

Drug

Sustanon- 200mg intramuscular testosterone

0.9% saline

Drug

Saline intramuscular injection every two weeks

Primary outcomes

  1. 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

Secondary outcomes

  1. The effect of testosterone on ultrasound measured intima-media thickness of the common carotid artery in the study population

    Time frame: 6 months

  2. The effect of testosterone on male hypogonadism as assessed by the Ageing Males Symptoms (AMS)

    Time frame: 6 months

  3. The effect of testosterone on markers of vascular risk; blood pressure, serum lipid levels, weight, waist circumference, body fat percentage,

    Time frame: 6 months

  4. urinary micro-albumin, tumour necrosis factor alpha, and highly sensitive C reactive protein levels in the study population.

    Time frame: 6 months

  5. 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

Sponsors and collaborators

Lead sponsor

Barnsley Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 7, 2006
Registry last updated
Mar 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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