Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-25 @ 4:52 AM
NCT ID:
NCT04786418
Eligibility Criteria:
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:
1. a diagnosis of prediabetes (HbA1c 42-47 mmol/mol), OR
2. NAFLD (based on fatty liver index, FLI \>60). FLI will be determined using waist circumference, BMI, serum triglyceride and GGT (gamma-glutamyltransferase). OR
3. 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04786418
Study Brief:
Protocol Section:
NCT04786418