Status:
COMPLETED
Testosterone for Men With Insulin Treated Type 2 Diabetes
Lead Sponsor:
Barnsley Hospital
Conditions:
Hypogonadism
Diabetes
Eligibility:
MALE
40+ years
Phase:
PHASE4
Brief Summary
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.
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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00349362
Start Date
July 1 2006
End Date
October 1 2008
Last Update
March 30 2010
Active Locations (1)
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1
Barnsley Hospital NHS Foundation Trust
Barnsley, South Yorkshire, United Kingdom, S75 2EP