Metformin improves endothelial function, endothelial progenitor cells and cardiovascular risk factors in type 1 diabetes
ISRCTN | ISRCTN26092132 |
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DOI | https://doi.org/10.1186/ISRCTN26092132 |
Secondary identifying numbers | 12264 |
- 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
Study design | Observational study |
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Primary study design | Observational |
Secondary study design | Other |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | 1. EPCs 2. Hill Colony Assay 3. Endothelial function Measured before and after metformin therapy |
Secondary outcome measures | No secondary outcome measures |
Overall study start date | 28/05/2012 |
Completion date | 01/04/2015 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 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
- England
- United Kingdom
Study participating centre
Gateshead Health NHS Foundation Trust
Gateshead
NE9 6SX
United Kingdom
NE9 6SX
United Kingdom
Sponsor information
Gateshead Health NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Queen Elizabeth Hospital
Sheriff Hill
Gateshead
NE9 6SX
England
United Kingdom
Phone | +44 (0)191 482 0000 |
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contact.qe@ghnt.nhs.uk | |
Website | http://www.gatesheadhealth.nhs.uk/ |
https://ror.org/01aye5y64 |
Funders
Funder type
Charity
Diabetes Research & Wellness Foundation (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Diabetes Research & Wellness Foundation, Diabetes Research and Wellness Foundation UK, DRWF
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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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 | 26/08/2016 | Yes | No |
Editorial Notes
07/02/2017: Publication reference added.