Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
12264
Study information
Scientific title
Metformin improves Endothelial function, endothelial progenitor cells and cardiovascular Risk factors In Type 1 diabetes (MERIT study)
Acronym
MERIT
Study hypothesis
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
NRES Committee North East - Sunderland, 12/04/2012, ref: 12/NE/0044
Study design
Observational study
Primary study design
Observational
Secondary study design
Other
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
1. EPCs
2. Hill Colony Assay
3. Endothelial function
Measured before and after metformin therapy
Secondary outcome measures
No secondary outcome measures
Overall trial start date
28/05/2012
Overall trial end date
01/04/2015
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
46
Participant 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
Recruitment start date
28/05/2012
Recruitment end date
01/04/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Gateshead Health NHS Foundation Trust
Gateshead
NE9 6SX
United Kingdom
Sponsor information
Organisation
Gateshead Health NHS Foundation Trust (UK)
Sponsor details
Queen Elizabeth Hospital
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom
+44 (0)191 482 0000
contact.qe@ghnt.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Diabetes Research & Wellness Foundation (UK)
Alternative name(s)
DRWF
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27561827