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
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