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Testosterone Replacement in Diabetes With Vascular Disease (Version 2)

This study has been completed.
Sponsor:
Information provided by:
Barnsley Hospital
ClinicalTrials.gov Identifier:
NCT00355537
First received: July 21, 2006
Last updated: March 29, 2010
Last verified: March 2010
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014