Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0034170256
Study information
Scientific title
Acronym
Study hypothesis
To the effect of 12 weeks of testosterone replacement, given as testosterone esters 200mg from Sustanon 250 IM injection, on arterial stiffness measured by ultrasound derived stiffness index B of the femoral artery in men with a combination of Diabetes Mellitus, Peripheral Vascular Disease and hypogonadism.
Ethics approval
Not provided at time of registration
Study design
Single centre randomised double blind placebo controlled parallel study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Nutritional, Metabolic, Endocrine: Diabetes
Intervention
Sustanon vs placebo
Intervention type
Drug
Phase
Not Specified
Drug names
Sustanon
Primary outcome measure
The effectiveness of 12 weeks of testosterone replacement, given as testosterone esters 200mg from Sustanon 250 IM injection, on arterial stiffness measured by ultrasound derived stiffness index B of the femoral artery in men with a combination of Diabetes Mellitus, PVD and hypogonadism.
Secondary outcome measures
The effects of testosterone on Glycated Haemoglobin.
Overall trial start date
01/10/2005
Overall trial end date
01/06/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Men with Diabetes M, hypogonadism and PVD
2. Older than 40 years old
3.Type 2 Diabetes Mellitus treated with insulin with or without oral hypoglycaemics
4. Serum testosterone less than 12mmol/L on two consecutive morning samples taken on different days
5. Symptoms attributable to hypogonadism in the opinion of the investigator
6. Agreement to maintain, diabetic antihypertensive and antilipid treatments at prior doses for the duration of the study
7. Ability to give written informed consent and verbal and written explanation in the English language
8. Ability to comply with all study requirements
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
30
Participant exclusion criteria
1. Current or previous breast cancer
2. Current or previous prostate cancer
3. Raised prostate specific antigen (PSA) or abnormal digital rectal examination suspicious of prostate cancer unless diagnosis excluded after specialist urology opinion and/or prostate biopsy
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
7. Any other reason considered significant by the investigators at the time of assessment
Recruitment start date
01/10/2005
Recruitment end date
01/06/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Medicine
Barnsley
S75 2EP
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Barnsley Hospital NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17468196
Publication citations
-
Results
Kapoor D, Clarke S, Stanworth R, Channer KS, Jones TH, The effect of testosterone replacement therapy on adipocytokines and C-reactive protein in hypogonadal men with type 2 diabetes., Eur. J. Endocrinol., 2007, 156, 5, 595-602, doi: 10.1530/EJE-06-0737.