Testosterone Replacement in Diabetes With Vascular Disease (Version 2)

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

Diabetes is a major cause of peripheral vascular disease(PVD) and is associated with male hypogonadism. Diabetes and PVD are both associated with arterial stiffness and intima -media thickness which are also related to severity of the clinical syndrome of PVD. Artificially induced hypogonadism results in increasing arterial stiffness whilst testosterone is known to improve risk factors for vascular disease and act as a vasodilator. The purpose of this pilot study is to assess the effect of testosterone treatment on PVD arterial stiffness and intima-media thickness in men with type 2 diabetes and hypogonadism,

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Peripheral Vascular Disease
• Intervention / Treatment: Drug: Testosterone; Drug: 0.9% saline

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • South Yorkshire
    • Barnsley, South Yorkshire, United Kingdom, S75 2 EP
      • 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:

• Male patients greater than 18 years of age
• Type 2 Diabetes Mellitus
• Serum testosterone less than 11 nmol/L on two consecutive samples taken on different days
• Peripheral vascular disease as defined by ABPI less than 0.92 and ischaemic leg pain (claudication or rest pain) or distal complications (non-healing arterial foot ulcer or gangrene
• Agreement to maintain antihypertensive and anti-lipid treatments at prior doses during 3 months of study
• Ability to give written informed consent after verbal and written explanation in the English Language
• Ability to comply with all study requirements

Exclusion Criteria:

• Current or previous breast cancer
• Current or previous prostate cancer
• Raised prostate specific antigen or abnormal per rectal examination unless prostate cancer excluded after specialist urology opinion
• Severe symptoms of benign prostatic hypertrophy ('prostatism')
• Treatment with testosterone in the 3 months prior to the trial
• 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	Drug: 0.9% saline; Saline injection intramuscular every 2 weeks
Experimental: Active	Drug: Testosterone; Sustanon- intramuscular testosterone 200mg every 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The effect of testosterone replacement on arterial stiffness measured by ultrasound derived index B of the femoral artery in men with a combination of DM, PVD and hypogonadism.	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The effect of testosterone on intima-media thickness of the femoral artery measured by ultrasound .	3 months
The effect of testosterone on peripheral circulation in legs affected by PVD as measured by transcutaneous oxygen saturation in the feet of the study population.	3 months
The effect of testosterone on PVD as measured by ankle-brachial-pressure-indices (ABPI) .	3 months
The effect of testosterone on markers of vascular risk; blood pressure, serum-lipid levels, weight, waist circumference, body fat percentage, urinary micro-albumin concentration and C reactive protein levels.	3 months

Collaborators and Investigators

• Sponsor: Barnsley Hospital
• Investigators: Principal Investigator: Hugh Jones, Barnsley Hospital NHS Foundation Trust

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 21, 2006
• First Submitted That Met QC Criteria: July 21, 2006
• First Posted (Estimate): July 24, 2006

Study Record Updates

• Last Update Posted (Estimate): March 30, 2010
• Last Update Submitted That Met QC Criteria: March 29, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Atherosclerosis; Diabetes Mellitus; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens; Testosterone
• Other Study ID Numbers: BDGH 237