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 |
| Protocol serial number | N0295122840 |
| Sponsor | Department of Health |
| Funder | University Hospitals Coventry and Warwickshire NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Insulin sensitivity before and after treatment and sodium excretion. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 10/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| 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
- United Kingdom
- England
Study participating centre
Diabetes Centre
Rugby
CV22 5PX
United Kingdom
CV22 5PX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
