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Dr Sam West
+44 1865 289120
sam.west@phc.ox.ac.uk


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Be Part of Research - Trial Details - LOGIC (LOw carbohydrate diets for Glucose Control in type 2 diabetes)
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LOGIC (LOw carbohydrate diets for Glucose Control in type 2 diabetes)

Recruiting

Open to: All Genders

Age: Adult

Oxford

Medical Conditions

Type 2 diabetes

This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.


Type 2 diabetes is a common disease in which a person’s blood glucose levels are too high. We know that what we eat affects our blood glucose levels, and that changing our diets and losing weight can both help to control type 2 diabetes. However, it is not clear what the best advice is to help people achieve this goal. We know that it is possible for some people to improve their blood glucose levels by following a low-carbohydrate diet (cutting out starchy and sugary foods), but it is not clear whether the benefits come from eating less carbohydrate itself, or from losing weight at the same time (from eating less overall). We want to help answer this question by comparing two sorts of low-carbohydrate diets – one designed to help people lose weight at the same time, and one where people stay at the same weight but improve their blood glucose levels by changing the food they eat. This will help us give better advice to people living with type 2 diabetes about what is the right diet for them, to help them achieve their health goals.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

15 Apr 2024 30 Dec 2024

This study will compare two types of low-carbohydrate eating plans (reducing the amount of starchy and sugary foods) – one will involve eating the same number of calories as usual each day, and one weight loss diet which will involve reducing the number of calories eaten each day to help weight loss (around 2-4kg over the 4 week diet period).
Participants will be randomly allocated (like tossing a coin) to one of these two eating plans. Food won’t be provided as part of this study, however, we will provide information and support to follow the eating plans at home. Participants will wear a device on their arm which measures blood glucose levels constantly throughout the day and night. Participants will attend three study visits at their local GP practice, where they will meet with one of the research team. During these visits, participants will be asked to answer some questions about diet and medication, complete questionnaires, and give blood samples. With the GP’s approval, we may pause some regular medication at the start of the study to prevent low blood sugar and low blood pressure. Weight and blood pressure will be monitored throughout the study.


We are looking for 30 people who have type 2 diabetes to take part in this study.

You can take part if:



You may not be able to take part if:


1. Pregnant, breastfeeding, or planning to become pregnant during the course of the study.2. Recent weight loss (> 2kg in last 4 weeks; self-reported).3. People who are already following a specific restricted diet.4. Are currently taking more than two prescribed medications for diabetes glycaemic control.5. People with HbA1c > = 87 mmol/mol.6. Are currently using insulin therapy, SGLT2 inhibitors (Gliflozins – eg empaglifozin, dapagliflozin, canagliflozin), or GLP-1 agonists (e.g. exenatide, lixisenatide, liraglutide, dulaglutide and semaglutide).7. Previous or current eating disorder (or any other psychological condition) that may affect the participant’s ability to adhere to study intervention/experimental diets. 8. Recent myocardial infarction or stroke (< 3 months).9. Renal failure (chronic kidney disease stage 4 or 5).10. Current active treatment for cancer (other than skin cancer treated with curative intent by local treatment only).11. Proliferative diabetic retinopathy, or maculopathy.12. GP feels inappropriate to take part in study (e.g. unable to attend study visits; end of life care, or would not benefit from weight loss or improved diabetes control).13. Most recent (non-fasting or fasting) triglyceride level > 5 mmol/l.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • NIHR CRN Thames Valley and South Midlands
    John Radcliffe Hospital Headley Way Headington
    Oxford
    OX3 9DU

Benefits
- We hope that most people who try the eating plans in this study will see some improvements in their blood glucose levels, which can be beneficial to health and general wellbeing.
- Many people with type 2 diabetes are keen to experience using a continuous glucose monitor (CGM), as these are not usually available on the NHS for this condition but can help with understanding how the diet affects blood glucose levels. Participants will get a 4 week period of CGM if you take part in this study.
- Knowledge gained in this study will help our research and in the future may help us advise people with diabetes about which types of diets might be most helpful for them.
- There are no known serious risks from the dietary advice that is being given in this study.
- Some people find blood tests temporarily uncomfortable, or that they can develop a small bruise afterwards.
- Some people may experience constipation if they reduce the amount of food they are eating during a weight loss diet, but we will give advice on how to avoid this if allocated to follow the weight loss diet.
- Some people will experience improvements in their blood sugar and/or blood pressure when following these eating plans, which could lead to someone experiencing low blood sugar or low blood pressure levels, but we will monitor blood pressure throughout the study and help manage medication to avoid this.
- If participants take warfarin medication, changes in diet could lead to a changes in INR levels, participants will be advised to inform the team monitoring INR levels that they will be following a new eating plant for 4 weeks and may recommend an additional blood test to monitor for any changes.

Dr Sam West
+44 1865 289120
sam.west@phc.ox.ac.uk



The study is sponsored by University of Oxford and funded by NIHR Oxford Biomedical Research Centre.



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Read full details for Trial ID: ISRCTN33756948

Or CPMS 58895

Last updated 02 May 2024

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