Testosterone Replacement in Diabetes With Vascular Disease (Version 2) - Full Text View

Sponsor:	Barnsley Hospital
Information provided by:	Barnsley Hospital
ClinicalTrials.gov Identifier:	NCT00355537

Purpose

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,

Condition	Intervention	Phase
Diabetes Mellitus Peripheral Vascular Disease	Drug: Testosterone Drug: 0.9% saline	Phase IV

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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2 Peripheral Arterial Disease Vascular Diseases

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

Further study details as provided by Barnsley Hospital:

Primary Outcome Measures:

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. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The effect of testosterone on intima-media thickness of the femoral artery measured by ultrasound . [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
The effect of testosterone on PVD as measured by ankle-brachial-pressure-indices (ABPI) . [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment:	19
Study Start Date:	February 2006
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Active	Drug: Testosterone Sustanon- intramuscular testosterone 200mg every 2 weeks
Placebo Comparator: Placebo	Drug: 0.9% saline Saline injection intramuscular every 2 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355537

Locations

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

Sponsors and Collaborators

Barnsley Hospital

Investigators

Principal Investigator:

Hugh Jones

Barnsley Hospital NHS Foundation Trust

More Information

No publications provided

Responsible Party:	Prof Hugh Jones, Barnsley Hospital
ClinicalTrials.gov Identifier:	NCT00355537 History of Changes
Other Study ID Numbers:	BDGH 237
Study First Received:	July 21, 2006
Last Updated:	March 29, 2010
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Testosterone

Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on February 09, 2012