Investigating a low carbohydrate/high protein diet in type 2 diabetes
Research type
Research Study
Full title
Pilot investigation into the effect of a low carbohydrate/high protein diet on cardiometabolic risk factors in obese patients with type 2 diabetes. An eight week randomised controlled trial.
IRAS ID
141401
Contact name
Sohail Mushtaq
Contact email
Sponsor organisation
University of Chester
Research summary
This is a pilot study of eight weeks dietary intervention in obese patients with type 2 diabetes mellitus. The study will investigate the impact of a low carbohydrate/high protein “Dukan“ diet on risk factors for heart disease and metabolic diseases including those effecting the liver and kidneys. A low-fat, energy restricted diet will be used as a control.
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 mellitus. The study proposed will investigate the impact of the diet on diabetic control and a wider variety of biochemical markers that indicate risk than previous studies have examined.
The study aims to recruit 32 obese participants with type 2 diabetes mellitus. 16 patients will be randomly allocated to each of two groups; the intervention group will follow the low carbohydrate/high protein diet for eight weeks and the other 16 participants (the control group) will follow a low-fat diet with 500-600kcal / day energy deficit (recommended by NICE). Both groups would be given the same level of correspondence.
The study will take place at the City Walls Medical Practice in Chester, and 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 carbohydare/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. Weight, height, waist circumference and percentage body fat will be measured at each appointment, and fasted bloods will be taken at the first and final appointment.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
13/NW/0864
Date of REC Opinion
4 Feb 2014
REC opinion
Further Information Favourable Opinion