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| LIMIT-1: Lowering the Incidence of vascular complications with Metformin in patients with Impaired glucose Tolerance and a recent transient ischaemic attack or minor ischaemic stroke: a phase II randomised, controlled trial |
| ISRCTN | ISRCTN54960762 |
| ClinicalTrials.gov identifier | |
| Public title | LIMIT-1: Lowering the Incidence of vascular complications with Metformin in patients with Impaired glucose Tolerance and a recent transient ischaemic attack or minor ischaemic stroke: a phase II randomised, controlled trial |
| Scientific title | |
| Acronym | LIMIT-1 |
| Serial number at source | N/A |
| Study hypothesis | Metformin will be tolerated in patients with Transient Ischaemic Attack (TIA) or minor ischaemic stroke and will result in blood glucose lowering. |
| Lay summary | |
| Ethics approval | Received from the Medical Ethics Committee of Erasmus Medical Centre on the 5th December 2006 (ref: NL15011.078.06 [local METC number MEC-2006-303]). |
| Study design | Randomised, open-label, multicentre, controlled, parallel group trial |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Transient ischaemic attack or minor ischaemic stroke |
| Participants - inclusion criteria |
1. Men or women 18 years and over
2. TIA/minor ischaemic stroke (modified Rankin Score three or less) within six months 3. Impaired fasting glucose (fasting glucose level of 5.6 to 6.9 mmol/L) and/or impaired glucose tolerance (two-hour post-load glucose level of 7.8 to 11.0 mmol/L) 4. Informed consent |
| Participants - exclusion criteria |
1. Known or newly diagnosed diabetes mellitus
2. Contraindication for metformin: 2.1. Renal impairment (serum creatinine greater than 135 micromol/L for men, and greater than 110 micromol/L for women) 2.2. Hepatic disease (liver enzymes increased twice the upper limit of normal) 2.3. A past history of lactic acidosis 2.4. Cardiac failure requiring pharmacological therapy 2.5. Chronic hypoxic lung disease 2.6. Pregnancy 2.7. Breast feeding 3. Severe comorbidity interfering with follow-up |
| Anticipated start date | 01/02/2007 |
| Anticipated end date | 01/02/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 40 |
| Interventions |
Patients will be randomised for metformin or no oral anti-diabetic drug (open-label) on top of optimal standard treatment, including lifestyle advice aimed at weight reduction and regular physical exercise.
Patients allocated to metformin will be treated with metformin for three months from the day of randomisation until study end. They will start with a daily dose of 500 mg that will be slowly increased in one-month time to a daily dose of 2,000 mg in two gifts. All patients will be followed for three months. |
| Primary outcome measure(s) |
1. Tolerability of metformin treatment (measured as number of patients still on treatment after three months)
2. The safety of metformin treatment (which will be continuously monitored) 3. The adjusted difference in two-hour post-load glucose levels at three months Primary outcomes will be measured at three months for feasability (safety will be continuously monitored). Primary outcome on effect on post-load glucose level will be measured at three months, expressed as a for baseline adjusted difference in mean two-hour post-load glucose levels at three months between treatment groups. |
| Secondary outcome measure(s) |
1. Differences in fasting glucose levels
2. Insulin resistance 3. Body mass index 4. Percentage of patients with a normal glucose tolerance at three months Secondary outcomes will be measured at three months, as a for baseline adjusted difference between groups. |
| Sources of funding | Erasmus Medical Centre (The Netherlands) |
| Trial website | |
| Publications | |
| Contact name | Ms Esther van der Heijden |
| Address |
Stroke Research Assistant
Erasmus Medical Centre Room Ee 22.42 P.O. Box 1738 |
| City/town | Rotterdam |
| Zip/Postcode | 3000 DR |
| Country | Netherlands |
| Tel | +31 (0)10 408 7818 |
| Fax | +31 (0)10 408 9446 |
| stroke-research@erasmusmc.nl | |
| Sponsor | Erasmus Medical Centre (The Netherlands) |
| Address |
Department of Neurology
P.O. Box 2040 |
| City/town | Rotterdam |
| Zip/Postcode | 3000 CA |
| Country | Netherlands |
| Sponsor website: | http://www.erasmusmc.nl/ |
| Date applied | 11/04/2007 |
| Last edited | 20/03/2008 |
| Date ISRCTN assigned | 11/04/2007 |
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