Testosterone Replacement in Diabetes With Vascular Disease (Version 2)

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00355537
• Other study ID #: BDGH 237
• Status: Completed
• Phase: Phase 4
• First received: July 21, 2006
• Last updated: March 29, 2010
• Start date: February 2006
• Est. completion date: December 2009

Study information

• Verified date: March 2010
• Source: Barnsley Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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,

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• 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:

• 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Drug:
• Testosterone
Sustanon- intramuscular testosterone 200mg every 2 weeks
• 0.9% saline
Saline injection intramuscular every 2 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	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	No
Secondary	The effect of testosterone on intima-media thickness of the femoral artery measured by ultrasound .		3 months	No
Secondary	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	No
Secondary	The effect of testosterone on PVD as measured by ankle-brachial-pressure-indices (ABPI) .		3 months	No
Secondary	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	No