Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
26/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mark Daly

ORCID ID

Contact details

Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5DW
United Kingdom
+44 (0)1392 403086
M.E.Daly@exeter.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0203132077

Study information

Scientific title

Acronym

Study hypothesis

Is a low glycaemic load, high mono-unsaturated fat diet superior to the conventional dietary approach in helping factors in Type 2 Diabetes?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Nutritional, Metabolic, Endocrine: Diabetes

Intervention

As of 26/03/2013 the status of this record was changed to 'stopped'. The trial was not started due to staff changes.

30-40 patients will be recruited to the study from the Exeter Diabetes and Vascular Health Centre. They will be randomised to receive either low carbohydrate, high MUFA dietary advice or standard low fat dietary advice. Final randomisation numbers are determined by change and concealed from the study worker to ensure that randomisation cannot be predicted as recruitment nears completion. Each group will have group education sessions on a monthly basis, and each individual will receive a one-to-one teaching session with a specialist dietitian. Dietary advice will be constant except for the variables being tested. Thus both groups will be advised to increase fruit and vegetable intake, eat oily fish, and will be instructed to follow a prescribed energy deficit of 750 kcal per day. Each participant will be in the study for 3 months. Patients will carry out food diaries to test to see if they have changed their dietary habits (at end of study), and metabolic parameters (lipids, HbA1c, weight change, blood pressure) will be measured at baseline and completion. The Diabetes Health Profile 19 will be used as a disease specific quality of life.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Does dietary advice based on the following points help people with Type 2 diabetes?
Lowering the dietary glycaemic load (by restricting carbohydrate intake by quantity and type)
Increasing mono-unsaturate fat intake (nuts/olive oil)
Study endpoints: Change in HbA1c, lipids, body mass, blood pressure, diet achieved, disease specific quality of life, dietary glycaemic load

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2003

Overall trial end date

31/12/2006

Reason abandoned

Lack of staff/facilities/resources

Eligibility

Participant inclusion criteria

Type 2 diabetes, Body Mass Index (BMI) >25, HbA1c 6.5% to 12%, ready to change lifestyle.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

40

Participant exclusion criteria

Unexplained weight loss or ketosis at baseline assessment, type 1 diabetes. They will be asked by specialist nurses in diabetes or clinicians working with them.

Recruitment start date

01/10/2003

Recruitment end date

31/12/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Devon & Exeter Hospital (Wonford)
Exeter
EX2 5DW
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Charity

Funder name

Royal Devon and Exeter NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Diabetes UK (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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