CALIBRATE, a low calorie diet study.
Research type
Research Study
Full title
Metabolic, multi-organ and microvascular effects of a low-calorie diet in younger obese with prediabetes and/or metabolic syndrome.
IRAS ID
270174
Contact name
Dan Cuthbertson
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 6 months, 31 days
Research summary
Prediabetes affects around 1 in every 5 people which is usually due to being overweight or obese. As a consequence, people with prediabetes have a 5-10 times higher risk of developing type 2 diabetes (referred to as diabetes). There is often co-existing high blood pressure and/or unhealthy cholesterol levels (collectively known as the ‘metabolic syndrome’). People with metabolic syndrome are more likely to suffer from a heart attack/stroke (cardiovascular disease). In addition, many people with predates will have ‘fatty liver disease’ (non-alcoholic fatty liver disease) which can result in major liver-related complications in later life.
Diabetes complications often seen at diagnosis suggesting complications may also be evident in many people at the earlier, prediabetes stage. Even when complications are not yet apparent, ‘pre-clinical’ abnormalities are frequently detectable with sensitive investigations. These complications, maybe delayed, prevented or even reversed with lifestyle intervention.
Weight loss remains the most effective lifestyle intervention. Even 1 kg of weight loss reduces the progression of prediabetes to diabetes by 16%. Greater weight loss is needed to prevent other complications: 10% weight loss can cause remission of established diabetes and improve the structure of the heart while 7% weight loss can reverse liver scarring.
This study will compare the effects of a safe and effective 12-month weight management intervention, in 44 people who are obese,33 participants will using a low-calorie (~800Kcal), liquid replacement diet for 12 weeks, followed by reintroduction of a 'normal' diet and weight maintenance. In comparator, 11 people will be in a standard care that currently being delivered within National Health System (NHS) care.
We will examine how weight loss improves the abnormalities of the bloods sugars, blood pressure, cholesterol, liver fate, heart and nerve function and structure. In an additional optional substudy, we will assess how the weight loss impacts upon appetite regulation within the brain and nerves.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
20/NW/0379
Date of REC Opinion
23 Nov 2020
REC opinion
Further Information Favourable Opinion