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 design	Observational study
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
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

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"	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 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.