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 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54960762 |
| Secondary identifying numbers | N/A |
- Submission date
- 11/04/2007
- Registration date
- 11/04/2007
- Last edited
- 20/03/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Esther van der Heijden
Scientific
Scientific
Stroke Research Assistant
Erasmus Medical Centre
Room Ee 22.42
P.O. Box 1738
Rotterdam
3000 DR
Netherlands
| Phone | +31 (0)10 408 7818 |
|---|---|
| stroke-research@erasmusmc.nl |
Study information
| Study design | Randomised, open-label, multicentre, controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | LIMIT-1 |
| Study objectives | Metformin will be tolerated in patients with Transient Ischaemic Attack (TIA) or minor ischaemic stroke and will result in blood glucose lowering. |
| Ethics approval(s) | 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]). |
| Health condition(s) or problem(s) studied | Transient ischaemic attack or minor ischaemic stroke |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Metformin |
| Primary outcome measure | 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 measures | 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. |
| Overall study start date | 01/02/2007 |
| Completion date | 01/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2007 |
| Date of final enrolment | 01/02/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Stroke Research Assistant
Rotterdam
3000 DR
Netherlands
3000 DR
Netherlands
Sponsor information
Erasmus Medical Centre (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Neurology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
| Website | http://www.erasmusmc.nl/ |
|---|---|
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Hospital/treatment centre
Erasmus Medical Centre (The Netherlands)
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 |
