Status:
COMPLETED
Low-Calorie Diet in People With Prediabetes/Metabolic Syndrome
Lead Sponsor:
University of Liverpool
Collaborating Sponsors:
University of Surrey
Perspectum
Conditions:
Obesity
NAFLD
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
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...
Detailed Description
Prediabetes affects up to 35% of the population. It is defined as an intermediate metabolic state of glucose dysregulation between normoglycaemia and type 2 diabetes (T2D). Prediabetic individuals hav...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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,
- Exclusion criteria:
- Individuals with normal glucose tolerance (NGT) or type 1 or type 2 diabetes (T2D).
- 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.
- planning pregnancy/6 months post-partum,
- 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).
- Planning pregnancy within the next 6 months and until \>6 months post-partum or breastfeeding
- Substance abuse e.g. drugs/alcohol.
- Eating disorder, previous bariatric surgery, currently taking weight loss drugs or already engaged with weight management service
- Learning difficulties
- A contraindication to magnetic resonance scanning will exclude the patient from the MRI component of the study
Exclusion
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04786418
Start Date
June 1 2021
End Date
December 31 2024
Last Update
June 27 2025
Active Locations (1)
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1
Liverpool University Hospital NHS Foundation Trust are an NHS organisation
Liverpool, United Kingdom, L97AL