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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00504712
Other study ID # 300
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date February 2006
Est. completion date December 2009

Study information

Verified date March 2022
Source Barnsley Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

There is increasing evidence of the linkage of type 2 diabetes with low testosterone levels in men.


Description:

Testosterone treatment has shown beneficial effects on blood sugar control and obesity in pilot studies in men with type 2 diabetes. Beneficial effects have also been seen on angina- a disease related to atherosclerosis (narrowing of the arterial blood vessels). Peripheral vascular disease is also caused by atherosclerosis. We hypothesise that testosterone will have beneficial effects on peripheral vascualr disease in men with low serum testosterone and type 2 diabetes.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Type 2 diabetes mellitus. 2. Serum testosterone 12 nmol/L or less on two consecutive samples taken on different days and symptoms compatible with hypogonadism. 3. Peripheral vascular disease as defined by - previous diagnosis by a specialist vascular surgeon OR - ABPI less than 0.92 and ischaemic leg pain (claudication or rest pain) or distal complications (non-healing arterial foot ulcer or gangrene). 4. Agreement to maintain antihypertensive and antilipid treatments at prior doses during 3 month duration of study. 5. Ability to give written informed consent after verbal and written explanation in the English language. 6. 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 per rectal examination unless prostate cancer excluded after specialist urology opinion. 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.

Study Design


Intervention

Drug:
Testosterone
Sustanon- 200mg- Intramuscular testosterone every 2 weeks
saline
Saline injection every two weeks

Locations

Country Name City State
United Kingdom Barnsley Hospital NHS Foundation Trust Barnsley South Yorkshire

Sponsors (1)

Lead Sponsor Collaborator
Barnsley Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Arterial Stiffness The primary outcome was the effect of 12 weeks testosterone replacement on arterial stiffness measured by ultrasound derived stiffness parameter ß of the femoral artery. A reduction in ultrasound derived stiffness parameter ß is clinically beneficial to patients and the study was looking for a reduction in this value. Stiffness index ß was calculated from the diastolic carotid artery diameter (Dd), systolic carotid artery diameter (Ds), diastolic blood pressure (BPd) and systolic blood pressure (BPs) using the formula; Stiffness index ß = (ln(Ps/Pd)) x Dd/(Ds-Dd). A full theoretical range of possible index scores does not exist. Baseline, 12 weeks, and 26 weeks
Secondary Change in IMT Progression of Carotid intima-media thickness measured in mm Baseline, 12 weeks, and 26 weeks
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