NCT04786418Completed
Low-Calorie Diet in People With Prediabetes/Metabolic Syndrome
Metabolic, Multi-organ and Microvascular Effects of a Low-calorIe Diet in Younger Obese With Prediabetes and/or Metabolic Syndrome
Source: ClinicalTrials.gov · Last updated 27 Jun 2025
Brief summary (registry, in English)
Significant weight reduction, achieved by low-calorie diet (LCD), will mobilise ectopic fat (visceral and particularly liver fat), improving insulin sensitivity and other metabolic syndrome components, with secondary beneficial effects on cardiac structure and function. This CALIBRATE study (metabolic, multi-organ and effects of low-calorie diet in younger obese patients with pre-diabetes) will compare the effects of a safe and effective 12-month weight management intervention, initially using a low-calorie, liquid replacement diet for 12 weeks, anticipating at least 10% reduction in body weight. The investigators will examine how much the weight loss improves the metabolic abnormalities that precede type 2 diabetes (T2D), and in reversing the pre-clinical/subtle clinical abnormalities of the liver and heart that precede liver and cardiovascular disease (CVD). This study will compare the effects of a safe and effective 12-month weight management intervention, initially using a low-calorie, liquid replacement diet for 12 weeks, followed by a weight maintenance phase. The investigators will examine how much the weight loss improves the metabolic and neuropathic abnormalities that precede and accompany type 2 diabetes (T2D), and in reversing the pre-clinical/subtle clinical abnormalities of the liver and heart that precede liver and cardiovascular disease. In an additional optional sub-study, the investigators will additionally assess how the weight loss impacts upon appetite regulation within the brain with functional MRI (fMRI).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 44 (actual)
- First submitted
- 21 Jan 2021
- Start date
- 1 Jun 2021
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- University of Liverpool
- Diseases
- Obesity, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT04786418
What you commit to
- Study type: Interventional
- Participants enrolled: 44
- From 1 Jun 2021 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Substance abuse e.g. drugs/alcohol.
- Eating disorder, previous bariatric surgery, currently taking weight loss drugs or already engaged with weight management service
Other illness
- known structural cardiac disease or anyone with major atherosclerotic disease
- history of stroke within the last 3 months
- Active mental health illness (e.g. severe depression, bipolar disorder, schizophrenia or other psychotic disorders). Use of drug with known major effects on bodyweight (e.g. corticosteroid, anti-psychotic, anticonvulsants etc).
Lab values
- Individuals with normal glucose tolerance (NGT) or type 1 or type 2 diabetes (T2D).
Other
- planning pregnancy/6 months post-partum,
- Planning pregnancy within the next 6 months and until \>6 months post-partum or breastfeeding
- Learning difficulties
- A contraindication to magnetic resonance scanning will exclude the patient from the MRI component of the study
Who the study is looking for
- The investigators shall recruit participants with the following characteristics:
- Men and women
- aged 18-55 years\*,
- BMI 30-40 kg/m2 , BMI\>27 kg/m2 for Chinese/South Asians
- Any one of the following three metabolic criteria:
- a diagnosis of prediabetes (HbA1c 42-47 mmol/mol), OR
- NAFLD (based on fatty liver index, FLI \>60). FLI will be determined using waist circumference, BMI, serum triglyceride and GGT (gamma-glutamyltransferase). OR
- a diagnosis of metabolic syndrome using the IDF metabolic syndrome criteria (see below,
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Liverpool University Hospital NHS Foundation Trust are an NHS organisation Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.