Metformin improves endothelial function, endothelial progenitor cells and cardiovascular risk factors in type 1 diabetes
| ISRCTN | ISRCTN26092132 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26092132 |
| Protocol serial number | 12264 |
| Sponsor | Gateshead Health NHS Foundation Trust (UK) |
| Funder | Diabetes Research & Wellness Foundation (UK) |
- Submission date
- 16/05/2012
- Registration date
- 13/07/2012
- Last edited
- 07/02/2017
- 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 Fahad Wali Ahmed
Scientific
Scientific
Gateshead Health NHS Foundation Trust
Department of Endocrinology
Queen Elizabeth Hospital
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational study |
| Secondary study design | Other |
| Study type | Participant information sheet |
| Scientific title | Metformin improves Endothelial function, endothelial progenitor cells and cardiovascular Risk factors In Type 1 diabetes (MERIT study) |
| Study acronym | MERIT |
| Study objectives | The aim is to examine the mechanism behind the beneficial cardiovascular effects of metformin. This will be achieved by studying the effect of metformin on endothelial progenitor cells (EPCs), their in vitro function and endothelial function in patients with type 1 diabetes. |
| Ethics approval(s) | NRES Committee North East - Sunderland, 12/04/2012, ref: 12/NE/0044 |
| Health condition(s) or problem(s) studied | Type 1 diabetes and cardiovascular disease |
| Intervention | Patients will be assessed before and after metformin therapy. Prior to commencement of metformin patients will undergo 6 weeks running in period to monitor their glycaemia and exclude presence of hypo-unawarness. During the 8 week study with metformin 500mg patients will aim to achieve unchanged glucose levels. This may require a reduction of insulin doses for the time of the study. The vascular assessment will include measurement of EPCs from peripheral blood, cultured early EPCs and their function in vitro and RNA studies. Patients will have their endothelial function assessed by EndoPAT. Follow Up Length: 3 month(s) |
| Intervention type | Other |
| Primary outcome measure(s) |
1. EPCs |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/04/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 46 |
| Key inclusion criteria | 1. Type 1 diabetes mellitus 2. Aged 16 years or over 3. HbA1c <= 8.5 4. Duration of diabetes of at least 5 years 5. Stable diabetes control for at least 2 months |
| Key exclusion criteria | 1. Glomerular filtration rate (GFR) < 45 ml/ min/ 1.73m2 2. Woman of childbearing age planning pregnancy 3. Pregnancy and/or lactation 4. Proliferative diabetic retinopathy 5. Cardiovascular disease/ischemic heart disease (IHD) 6. Peripheral vascular disease 7. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) 8. Suspected hypoglycaemia unawareness 9. Impaired cognitive function/ unable to give informed consent 10. History of lactic acidosis 11. Contraindications to metformin 12. History of alcohol problem or drug abuse |
| Date of first enrolment | 28/05/2012 |
| Date of final enrolment | 01/04/2015 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Gateshead Health NHS Foundation Trust
Gateshead
NE9 6SX
United Kingdom
NE9 6SX
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 | 26/08/2016 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
07/02/2017: Publication reference added.
