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
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
-
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.