Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Azlinda Hamid
Azlinda.Hamid@liverpool.ac.uk


Prof Dan Cuthbertson
Dan.Cuthbertson@liverpool.ac.uk


Study Location:

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Be Part of Research - Trial Details - CALIBRATE, a low calorie diet study.

CALIBRATE, a low calorie diet study.

Completed

Open to: Female / Male

Age: 18 Years - 55 Years

Medical Conditions

Obesity and other hyperalimentation
Abnormal findings on examination of blood, without diagnosis


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. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

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:

03 Jun 2021 01 Jul 2024

Interventional

Interventional type: Dietary;



You can take part if:



You may not be able to take part if:


Exclusion criteria 1. Individuals with normal glucose tolerance (NGT) or type 1 or type 2 diabetes. 2. Anyone engaged in active weight loss (> 5kg weight loss in the last 6 months), currently engaged with weight management service, previous bariatric surgery, on weight-lowering medications (e.g. orlistat or liraglutide) or with a history of an eating disorder. 3. known structural cardiac disease or anyone with major atherosclerotic disease 4. history of stroke within the last 3 months 5. Active mental health illness (e.g. severe depression, bipolar disorder, schizophrenia or other psychotic disorders) 6. Planning pregnancy within the next 6 months and until > 6 months post-partum or breastfeeding 7. Substance abuse e.g. drugs/alcohol. 8. Eating disorder, previous bariatric surgery, currently taking weight loss drugs or already engaged with weight management service 9. Learning difficulties 10. A contraindication to magnetic resonance scanning will exclude the patient from the MRI component of the study


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

  • Vauxhall Health Centre
    Limekiln Lane
    Liverpool
    Merseyside
    L5 8XR
  • Myrtle Group Practice
    270 Telegraph Road
    heswall
    Wirral
    Merseyside
    CH60 7RN


The study is sponsored by University of Liverpool and funded by European Foundation for the Study of Diabetes .





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for Trial ID: CPMS 46978

Last updated 21 November 2024

This page is to help you find out about a research study and if you may be able to take part

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