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
40 Years
N/A
Male
Hypogonadism, Diabetes
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
The effect of 6 months of testosterone replacement on diabetes control measured by HbA1c in hypogonadal men with type 2 diabetes treated with insulin.
Outcome Time Frame:
6 months
Principal Investigator
Hugh Jones, BSc MD FRCP
Investigator Role:
Principal Investigator
Investigator Affiliation:
Barnsley Hospital NHS Foundation Trust
Authority:
United Kingdom: National Health Service
Study ID:
BDGH 264
NCT ID:
NCT00349362
Start Date:
July 2006
Completion Date:
October 2008
Related Keywords:
- Hypogonadism
- Diabetes
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypogonadism
Name | Location |
|---|
