Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
18/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr TH Jones

ORCID ID

Contact details

Medicine
Barnsley District General Hospital NHS Trust
Gawber Road
Barnsley
S75 2EP
United Kingdom

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17468196

Publication citations

  1. 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.

Additional files

Editorial Notes