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Testosterone for Peripheral Vascular Disease

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ClinicalTrials.gov Identifier: NCT00504712
Recruitment Status : Completed
First Posted : July 20, 2007
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Barnsley Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Hypogonadism Peripheral Vascular Disease Type 2 Diabetes Drug: Testosterone Drug: saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : February 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active
Testosterone 200 mg intramuscular every 2 weeks
Drug: Testosterone
Sustanon- 200mg- Intramuscular testosterone every 2 weeks

Placebo Comparator: Placebo
Saline
Drug: saline
Saline injection every two weeks




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

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00504712


Locations
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United Kingdom
Barnsley Hospital NHS Foundation Trust
Barnsley, South Yorkshire, United Kingdom, S75 2EP
Sponsors and Collaborators
Barnsley Hospital
Investigators
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Principal Investigator: T Hugh Jones Barnsley Hospital

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Responsible Party: Barnsley Hospital
ClinicalTrials.gov Identifier: NCT00504712     History of Changes
Other Study ID Numbers: 300
First Posted: July 20, 2007    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Keywords provided by Barnsley Hospital:
Testosterone
Hypogonadism
Diabetes
PVD
RCT
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Diabetes Mellitus, Type 2
Hypogonadism
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases
Gonadal Disorders
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents