Manchester Intermittent and Daily diet Diabetes App Study (MIDDAS)
Research type
Research Study
Full title
A Pilot randomised controlled trial comparing efficacy of Continuous Very Low Energy Diet (C-VLED) to Intermittent Very Low Energy Diet (I-VLED) in patients with Type 2 Diabetes
IRAS ID
226274
Contact name
Basil Issa
Contact email
Sponsor organisation
University Hospital of South Manchester NHS FT
Clinicaltrials.gov Identifier
2017-001201-32 , EudraCT No
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Currently in the UK 1 in 12 people are living with Type 2 diabetes, and this figure continues to rise.
Diet, maintaining a healthy weight and physical activity are the cornerstone of Type 2 diabetes treatment and can significantly reduce the need for medications and long term complications of the condition.
Studies in the UK have shown that an 8 week low calorie diet consisting of 800 calories/day, which has become known as the “Newcastle Diet”, can be highly effective in producing significant weight loss and normalisation of blood glucose. in people with Type 2 diabetes
This randomised study will be comparing the standard daily 800 kcal low calorie diet for eight weeks to an intermittent low calorie diet which involves two 800 kcal days/week spread over 27 weeks. The patients will be randomly allocated to one of these weight loss diets and then enter a diet and physical activity weight maintenance plan for the remainder of the 12 month programme. We want to know which diet is more effective at helping participants lose weight and achieve better blood glucose control.We are also testing whether we can successfully support patients with these diets remotely using a novel app/web based programme, rather than normal face to face appointments.
The study is including adults diagnosed with type 2 diabetes in the last 8 years who are currently overweight or obese (BMI >27 Kg/m2. The study will be carried out at University Hospital South Manchester and include patients from the hospital and local GP practices.
We are studying both diet groups for 12 months, which involves five assessment appointments at the University Hospital South Manchester. These appointments include assessment of changes in weight, a number of blood tests and well-being assessed with questionnaires.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
17/NW/0389
Date of REC Opinion
14 Aug 2017
REC opinion
Further Information Favourable Opinion