Metformin improves endothelial function, endothelial progenitor cells and cardiovascular risk factors in type 1 diabetes

ISRCTN ISRCTN26092132
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

Gateshead Health NHS Foundation Trust
Department of Endocrinology
Queen Elizabeth Hospital
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom

Study information

Study designObservational study
Primary study designObservational
Secondary study designOther
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleMetformin improves Endothelial function, endothelial progenitor cells and cardiovascular Risk factors In Type 1 diabetes (MERIT study)
Study acronymMERIT
Study objectivesThe 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) studiedType 1 diabetes and cardiovascular disease
InterventionPatients 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 typeOther
Primary outcome measure1. EPCs
2. Hill Colony Assay
3. Endothelial function

Measured before and after metformin therapy
Secondary outcome measuresNo secondary outcome measures
Overall study start date28/05/2012
Completion date01/04/2015

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants46
Key inclusion criteria1. 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 criteria1. 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 enrolment28/05/2012
Date of final enrolment01/04/2015

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Gateshead Health NHS Foundation Trust
Gateshead
NE9 6SX
United Kingdom

Sponsor information

Gateshead Health NHS Foundation Trust (UK)
Hospital/treatment centre

Queen Elizabeth Hospital
Sheriff Hill
Gateshead
NE9 6SX
England
United Kingdom

Phone +44 (0)191 482 0000
Email contact.qe@ghnt.nhs.uk
Website http://www.gatesheadhealth.nhs.uk/
ROR logo "ROR" https://ror.org/01aye5y64

Funders

Funder type

Charity

Diabetes Research & Wellness Foundation (UK)
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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.