Testosterone Replacement in Diabetes Mellitus with Vascular Disease

Completed

• Conditions: utritional, Metabolic, Endocrine: Diabetes; Nutritional, Metabolic, Endocrine; Diabetes

• Registration Number: ISRCTN07197979
• Lead Sponsor: Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-28
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

1. Men with Diabetes M, hypogonadism and PVD
2. Older than 40 years old
3.Type 2 Diabetes Mellitus treated with insulin with or without oral hypoglycaemics
4. Serum testosterone less than 12mmol/L on two consecutive morning samples taken on different days
5. Symptoms attributable to hypogonadism in the opinion of the investigator
6. Agreement to maintain, diabetic antihypertensive and antilipid treatments at prior doses for the duration of the study
7. Ability to give written informed consent and verbal and written explanation in the English language
8. Ability to comply with all study requirements

Exclusion Criteria

1. Current or previous breast cancer
2. Current or previous prostate cancer
3. Raised prostate specific antigen (PSA) or abnormal digital rectal examination suspicious of prostate cancer unless diagnosis excluded after specialist urology opinion and/or prostate biopsy
4. Severe symptoms of benign prostatic hypertrophy (prostatism)
5. Treatment with testosterone in the 3 months prior to the trial.
6. Investigational drug treatment in the 3 months prior to the trial
7. Any other reason considered significant by the investigators at the time of assessment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The effectiveness of 12 weeks of testosterone replacement, given as testosterone esters 200mg from Sustanon 250 IM injection, on arterial stiffness measured by ultrasound derived stiffness index B of the femoral artery in men with a combination of Diabetes Mellitus, PVD and hypogonadism.

Secondary Outcome Measures

Name	Time	Method
The effects of testosterone on Glycated Haemoglobin.