Trial record 2 of 5272 for:
Open Studies | "Vascular Diseases"
Testosterone for Peripheral Vascular Disease
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Barnsley Hospital.
Recruitment status was Recruiting
Information provided by:
First received: July 19, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
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.
Peripheral Vascular Disease
Type 2 Diabetes
Drug: 0.9% saline
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||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
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:
| Study Start Date:
| Estimated Study Completion Date:
Testosterone 200 mg intramuscular every 2 weeks
Sustanon- 200mg- Intramuscular testosterone every 2 weeks
Placebo Comparator: PLACEBO
Drug: 0.9% saline
Saline injection every two weeks
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Type 2 diabetes mellitus.
- Serum testosterone 12 nmol/L or less on two consecutive samples taken on different days and symptoms compatible with hypogonadism.
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).
- Agreement to maintain antihypertensive and antilipid treatments at prior doses during 3 month duration of study.
- Ability to give written informed consent after verbal and written explanation in the English language.
- Ability to comply with all study requirements.
- Current or previous breast cancer.
- Current or previous prostate cancer.
- Raised prostate specific antigen (PSA) 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00504712
|Barnsley Hospital NHS Foundation Trust
|Barnsley, South Yorkshire, United Kingdom, S75 2EP |
|Contact: Roger D Stanworth 01226 777947 firstname.lastname@example.org |
||T Hugh Jones
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 19, 2007
||July 19, 2007
||United Kingdom: Medicines and Healthcare Products Regulatory Agency
Keywords provided by Barnsley Hospital:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 09, 2014
Peripheral Vascular Diseases
Diabetes Mellitus, Type 2
Peripheral Arterial Disease
Glucose Metabolism Disorders
Endocrine System Diseases
Arterial Occlusive Diseases
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal