Testosterone for Peripheral Vascular Disease

Type 2 Diabetes Clinical Trial

Official title:

A Randomised, Double Blind, Placebo Controlled, Parallel Pilot Study to Test the Effect of Testosterone Treatment on Peripheral Vascular Disease in Hypogonadal Men With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00504712
• Other study ID #: 300
• Status: Completed
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hypogonadism
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Type 2 Diabetes
• Vascular Diseases

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