Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
15/05/2012
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 Paul O'Hare

ORCID ID

Contact details

Diabetes Centre
St Cross Hospital
Barby Road
Rugby
CV22 5PX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0295122840

Study information

Scientific title

Acronym

Study hypothesis

Type 2 diabetes is linked to molecular mechanisms of insulin resistance. Rosiglitazone restores impaired sodium excretion in type 2 diabetes by causing increased insulin sensitivity in the kidneys and within the peripheral vasculature.

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

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Nutritional, Metabolic, Endocrine: Diabetes

Intervention

Prospective Randomised Controlled Trial.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Insulin sensitivity before and after treatment and sodium excretion.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

17/07/2002

Overall trial end date

10/12/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with Type 2 Diabetes and impaired glucose tolerance (48).

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

17/07/2002

Recruitment end date

10/12/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Diabetes Centre
Rugby
CV22 5PX
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospitals Coventry and Warwickshire NHS 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. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18230694

Publication citations

  1. Results

    Goenka N, Kotonya C, Penney MD, Randeva HS, O'Hare JP, Thiazolidinediones and the renal and hormonal response to water immersion-induced volume expansion in type 2 diabetes mellitus., Am. J. Physiol. Endocrinol. Metab., 2008, 294, 4, E733-9, doi: 10.1152/ajpendo.00583.2007.

Additional files

Editorial Notes