Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/05/2012
Date assigned
13/07/2012
Last edited
13/07/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Fahad Wali Ahmed

ORCID ID

Contact details

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

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

We aim 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.

More details can be found at http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12264

Ethics approval

NRES Committee North East - Sunderland, 12 April 2012, ref: 12/NE/0044

Study design

Observational study

Primary study design

Observational

Secondary study design

Other

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below 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

http://www.gatesheadhealth.nhs.uk/

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

Publication citations

Additional files

Editorial Notes