Testosterone for Peripheral Vascular Disease

Phase 4

Completed

• Conditions: Hypogonadism; Peripheral Vascular Disease; Type 2 Diabetes
• Interventions: Drug: saline; Drug: Testosterone

• Registration Number: NCT00504712
• Lead Sponsor: Barnsley Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2007-07-19
• Study First Submitted QC: 2007-07-19
• Study First Posted: 2007-07-20
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2021-06-30
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-03
• Results First Posted: 2022-05-18
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	saline	Saline
Active	Testosterone	Testosterone 200 mg intramuscular every 2 weeks

Primary Outcome Measures

Name	Time	Method
Change in Arterial Stiffness	Baseline, 12 weeks, and 26 weeks	The primary outcome was the effect of 12 weeks testosterone replacement on arterial stiffness measured by ultrasound derived stiffness parameter β of the femoral artery. A reduction in ultrasound derived stiffness parameter β is clinically beneficial to patients and the study was looking for a reduction in this value. Stiffness index β 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 β = (ln(Ps/Pd)) x Dd/(Ds-Dd). A full theoretical range of possible index scores does not exist.

Secondary Outcome Measures

Name	Time	Method
Change in IMT	Baseline, 12 weeks, and 26 weeks	Progression of Carotid intima-media thickness measured in mm

Trial Locations

Locations (1)

Barnsley Hospital NHS Foundation Trust; 🇬🇧 Barnsley, South Yorkshire, United Kingdom