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 |
| Secondary identifying numbers | N0203132077 |
- 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
Scientific
Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5DW
United Kingdom
| Phone | +44 (0)1392 403086 |
|---|---|
| M.E.Daly@exeter.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 01/10/2003 |
| 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 number of participants | 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
- England
- United Kingdom
Study participating centre
Royal Devon & Exeter Hospital (Wonford)
Exeter
EX2 5DW
United Kingdom
EX2 5DW
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Charity
Royal Devon and Exeter NHS Trust (UK)
No information available
Diabetes UK (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- DIABETES UK LIMITED, British Diabetic Association
- 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 |
