Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
12/11/2008
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

N0034128967

Study information

Scientific title

Acronym

Study hypothesis

To assess the effect of testosterone on glycaemic control and insulin sensitivity in type 2 diabetic men with hypogonadism.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Nutritional, Metabolic, Endocrine: Hypogonadism

Intervention

Testosterone replacement vs placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Testosterone

Primary outcome measures

Efficacy of testosterone replacement

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/2003

Overall trial end date

31/07/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Diabetic men above 30 yrs old with hypogonadism

Participant type

Patient

Age group

Not Specified

Gender

Male

Target number of participants

20 male patients

Participant exclusion criteria

Hormone manipulating therapy, inflammatory disease, infection, prostate carcinoma, elevated PSA

Recruitment start date

01/02/2003

Recruitment end date

31/07/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Medicine
Barnsley
S75 2EP
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

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), BDGH Small Projects Fund (internal funding)

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

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16728551

Publication citations

  1. Results

    Kapoor D, Goodwin E, Channer KS, Jones TH, Testosterone replacement therapy improves insulin resistance, glycaemic control, visceral adiposity and hypercholesterolaemia in hypogonadal men with type 2 diabetes., Eur. J. Endocrinol., 2006, 154, 6, 899-906, doi: 10.1530/eje.1.02166.

Additional files

Editorial Notes