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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT05468151
Eligibility Criteria:
Inclusion Criteria:
* BMI\>30kg/m2 (for participants with obesity)
* BMI\<25kg/m2 (for lean participants)
* Waist circumference \>94 cm for men (for participants with obesity)
* Waist circumference \> 80 for women (for participants with obesity)
* Glucose ≥7.8 and \<11 mmol/L after OGTT (for participants with obesity)
Exclusion Criteria:
* Being regularly exposed to cold environments for the last 3 months (e.g. having a job as a ski monitor, fishmonger, woodcutter, etc.; or doing sports/leisure activities outdoors for prolonged periods of time, etc.)
* Having gone for winter/ice swimming and bathing more than once every 2 weeks during the last 3 months.
* Inability to undergo scanning (e.g., claustrophobia)
* Pregnancy
* Smoking (or use of nicotine based products)
* Hypo/hyperthyroidism
* Malignancies
* Immune disorders
* Viral or bacterial infections
* Abnormal cardiovascular status, arrhythmia and/or long QTc in ECG, abnormal cardiac murmur, previous history of cardiovascular disease
* Allergy to lidocaine or epinephrine, or other local anaesthetics
* Weight change (intentional or not) over the last 6-months \> than 5% of body weight
* Any other cardiovascular, pulmonary, orthopaedic, neurologic, psychiatric or other conditions that in the opinion of the local clinician/researcher, would preclude participation and successful completion of the protocol, or that would negatively impact or mitigate participation in and completion of the protocol.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05468151
Study Brief:
Protocol Section:
NCT05468151