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Dr Sohail Mushtaq


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Be Part of Research - Trial Details - Investigating a low carbohydrate/high protein diet in type 2 diabetes patients
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Investigating a low carbohydrate/high protein diet in type 2 diabetes patients

Not Recruiting

Open to: All Genders

Age: Adult

Chester

Medical Conditions

Type 2 diabetes mellitus

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.


There is evidence that low carbohydrate/high protein diets lead to improvements in weight, diabetic control and certain biochemical markers in patients with type 2 diabetes. This study will investigate the impact of the Dukan diet on diabetic control and a wider variety of biochemical markers than have previously been studied; this will give an indication of the safety of the diet. The aim to find out if a low carbohydrate/high protein diet leads to improvements in risk factors for heart disease and other complications in obese patients with type 2 diabetes.

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:

23 Apr 2014 02 Apr 2015

Participants will be randomly to one of two groups: one group will follow a low carbohydrate/high protein diet for eight weeks and the other 16 participants will follow a low-fat diet with 500-600kcal/day energy deficit. Participants will attend three clinic appointments during the eight week study. Dietary education will be provided at the first appointment; participants will be given instructions by a dietitian on how to follow either the low carbohydrate/high protein diet or a low-fat 500-600kcal deficit diet and written information will be provided. Adherence to the diet will be monitored at follow-up through a three day diet diary and dietary interviews. At each appointment, weight, height, waist circumference, percentage body fat and blood pressure will be measured and fasted blood samples will be taken.


The study aims to recruit 32 obese males and females with type 2 diabetes mellitus, aged 18-75 from the City Walls Medical Centre, Chester, UK.

You can take part if:


Current inclusion criteria as of 18/09/2014:
1. Male or female, aged 18-75
2. BMI 28-40 kg/m*2
3. HbA1c <86 mmol and a diagnosis of diabetes confirming to WHO guidelines
4. Stable medication at least three months prior to the study
5. Diabetes managed with Metformin or lifestyle only
6. English speaking with


You may not be able to take part if:


Current exclusion criteria as of 18/09/2014:1. History of eating disorder2. Currently following a restrictive diet3. Currently taking part in other research4. Impaired kidney function5. Impaired liver function6. Patients taking medications to reduce blood clots7. Pregnant women8. Non-English speaking9. No internet access

Previous exclusion criteria:1. History of eating disorder2. Currently following a restrictive diet3. Currently taking part in other research4. Impaired kidney function5. Impaired liver function6. Patients taking medications to reduce blood clots or promote production of urine7. Pregnant women8. Non-English speaking9. No internet access


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

  • University of Chester
    Chester
    CH1 4BJ

The potential benefits for research participants in both study groups are an improvement in diabetic control, a reduction in weight and reduced risk of long-term complications including cardiovascular disease, renal disease and liver complications. While undertaking the study participants will benefit from more regular dietetic input and increased access to the dietitian than they would receive in standard care. There is potential burden on participants in the study due to increased contact with the dietitian, the changes in lifestyle associated with following a new diet, and the burden of completing diet diaries. There will be regular dietetic support to help participants follow the diets; the diet diary will also help with this and is an important tool for monitoring participant compliance. The burden of increased contact will be limited as the visits will be held at the participants' normal GP surgery. The other potential risk to the participant is that associated with obtaining blood samples; this will be minimized as fully trained nurses/phlebotomists will be responsible for collecting these samples.

Dr Sohail Mushtaq



The study is sponsored by University of Chester (UK) and funded by Regime Dukan (UK); University of Chester (UK).



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Read full details for Trial ID: ISRCTN05903336
Last updated 10 January 2017

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