Modification of carbohydrate quantity and quality whilst increasing mono-unsaturated fatty acid (MUFA) intake in Type 2 Diabetes

ISRCTN	ISRCTN11304233
DOI	https://doi.org/10.1186/ISRCTN11304233
Protocol serial number	N0203132077
Sponsor	Department of Health
Funders	Royal Devon and Exeter NHS Trust (UK), Diabetes UK (UK)

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 26/03/2013

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mark Daly
Scientific

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

Phone	+44 (0)1392 403086
Email	M.E.Daly@exeter.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2006
Reason abandoned (if study stopped)	Lack of staff/facilities/resources

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	40
Key inclusion criteria	Type 2 diabetes, Body Mass Index (BMI) >25, HbA1c 6.5% to 12%, ready to change lifestyle.
Key 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.
Date of first enrolment	01/10/2003
Date of final enrolment	31/12/2006

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Royal Devon & Exeter Hospital (Wonford)

Exeter
EX2 5DW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan