Testosterone for Peripheral Vascular Disease

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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; Peripheral Vascular Disease; Hypogonadism
• Intervention / Treatment: Drug: Testosterone; Drug: saline

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • South Yorkshire
    • Barnsley, South Yorkshire, United Kingdom, S75 2EP
      • Barnsley Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Saline	Drug: saline; Saline injection every two weeks
Experimental: Active; Testosterone 200 mg intramuscular every 2 weeks	Drug: Testosterone; Sustanon- 200mg- Intramuscular testosterone every 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Arterial Stiffness	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.	Baseline, 12 weeks, and 26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in IMT	Progression of Carotid intima-media thickness measured in mm	Baseline, 12 weeks, and 26 weeks

Collaborators and Investigators

• Sponsor: Barnsley Hospital
• Investigators: Principal Investigator: Thomas H Jones, Barnsley Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: July 19, 2007
• First Submitted That Met QC Criteria: July 19, 2007
• First Posted (Estimate): July 20, 2007

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Diabetes; RCT; Hypogonadism; PVD; Testosterone
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Gonadal Disorders; Diabetes Mellitus; Atherosclerosis; Diabetes Mellitus, Type 2; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Hypogonadism; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens; Testosterone
• Other Study ID Numbers: 300