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:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-24 @ 4:59 PM
NCT ID:
NCT04315350
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) \>24.9 kg/m2, If participant is included during COVID19-pandemic, maximum BMI is 32 kg/m2
* Haemoglobin ≥7.5 mmol/l
* Written informed consent
Exclusion Criteria:
If the participant is screened during COVID19, extra exclusion criteria is age\>59 years.
If the participant is screened during COVID19-pandemic, following exclusion criteria is also applicable: 1) Diagnosed with asthma requiring medication or having uncontrolled asthma. 2) Beeing a current smoker. 3) diagnosed with hypertension. 4) having a job or engaging in daily activities, where it is not possible to adhere to the required distance of one meter to other people, judged by the investigator. 5) bA1c above 42 mmol/mol at screening.
* Use of glucose-lowering drugs, lipid-lowering drugs, warfarin, clopidogrel or non-vitamin K anti-coagulants
* Frequent use of anti-inflammatory drugs the last two months prior to inclusion, judged by the investigator
* Treatment with drugs with potential steatogenic side-effects within two months prior to inclusion
* Use of medication known to interact with prednisolone
* Use of curcumin-containing food supplements or other natural products that could cause confounding as evaluated by investigator
* Any regular drug treatment that cannot be discontinued for minimum 18 hours
* Previous diagnosis of T2D
* Diabetes (HbA1c ≥ 48 mmol/mol) found at screening
* Known viral, inherited or alcoholic liver disease, or any other condition known to affect liver
* Intake of more than 21 units of alcohol per week
* Nephropathy (eGFR \< 60 ml/min/1.73 m² and/or urine albumin \> 20 mg/l)
* In a weight management program, or planning to change life style, alcohol habits or eating habits during the course of the study
* Implanted metal objects contraindicative of MRS Claustrophobia
* Any condition that the investigator think would interfere with trial participation or with the safety of the participant.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT04315350
Study Brief:
Protocol Section:
NCT04315350