Effects of Rosiglitazone on fluid retention and insulin resistance in response to Head-out immersion in individuals with type 2 diabetes and impaired glucose tolerance.
| ISRCTN | ISRCTN40816592 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40816592 |
| Secondary identifying numbers | N0295122840 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 15/05/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Paul O'Hare
Scientific
Scientific
Diabetes Centre
St Cross Hospital
Barby Road
Rugby
CV22 5PX
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nutritional, Metabolic, Endocrine: Diabetes |
| Intervention | Prospective Randomised Controlled Trial. |
| Intervention type | Other |
| Primary outcome measure | Insulin sensitivity before and after treatment and sodium excretion. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 17/07/2002 |
| Completion date | 10/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Patients with Type 2 Diabetes and impaired glucose tolerance (48). |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 17/07/2002 |
| Date of final enrolment | 10/12/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Diabetes Centre
Rugby
CV22 5PX
United Kingdom
CV22 5PX
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Hospital/treatment centre
University Hospitals Coventry and Warwickshire NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2008 | Yes | No |
