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Testosterone for Peripheral Vascular Disease
This study is currently recruiting participants.
Verified by Barnsley Hospital, July 2007
First Received: July 19, 2007   No Changes Posted
Sponsored by: Barnsley Hospital
Information provided by: Barnsley Hospital
ClinicalTrials.gov Identifier: NCT00504712
  Purpose

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


Condition Intervention Phase
Hypogonadism
Peripheral Vascular Disease
Type 2 Diabetes
Drug: Testosterone
Drug: 0.9% saline
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Barnsley Hospital:

Primary Outcome Measures:
  • Change in arterial stiffness [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Change in IMT [ Time Frame: 3 months ]
  • Change in transcutaneous oxygen level [ Time Frame: 3 months ]
  • Change in ABPI [ Time Frame: 3 months ]
  • Change in Walking Impairment Questionnaire [ Time Frame: 3 months ]

Estimated Enrollment: 30
Study Start Date: February 2006
Estimated Study Completion Date: February 2008
Arms Assigned Interventions
ACTIVE: Experimental
Testosterone 200 mg intramuscular every 2 weeks
Drug: Testosterone
Sustanon- 200mg- Intramuscular testosterone every 2 weeks
PLACEBO: Placebo Comparator Drug: 0.9% saline
Saline injection every two weeks

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00504712

Contacts
Contact: Roger D Stanworth 01226 777947 roger.stanworth@nhs.net

Locations
United Kingdom, South Yorkshire
Barnsley Hospital NHS Foundation Trust Recruiting
Barnsley, South Yorkshire, United Kingdom, S75 2EP
Contact: Roger D Stanworth     01226 777947     roger.stanworth@nhs.net    
Sponsors and Collaborators
Barnsley Hospital
Investigators
Principal Investigator: T Hugh Jones Barnsley Hospital
  More Information

No publications provided

Study ID Numbers: 300
Study First Received: July 19, 2007
Last Updated: July 19, 2007
ClinicalTrials.gov Identifier: NCT00504712     History of Changes
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Barnsley Hospital:
Testosterone
Hypogonadism
Diabetes
PVD
RCT

Study placed in the following topic categories:
Peripheral Vascular Diseases
Metabolic Diseases
Antineoplastic Agents, Hormonal
Gonadal Disorders
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Methyltestosterone
Hormones
Testosterone 17 beta-cypionate
Anabolic Agents
Testosterone
Hypogonadism
Diabetes Mellitus, Type 2
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Androgens

Additional relevant MeSH terms:
Peripheral Vascular Diseases
Metabolic Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Gonadal Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Methyltestosterone
Hormones
Pharmacologic Actions
Testosterone 17 beta-cypionate
Anabolic Agents
Testosterone
Hypogonadism
Therapeutic Uses
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Glucose Metabolism Disorders
Androgens

ClinicalTrials.gov processed this record on September 11, 2009