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 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT05898204
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 65 years
* BMI≥ 30 Kg/m2
Exclusion Criteria:
* Type 1 diabetes mellitus and latent autoimmune diabetes in adults
* β-cell failure in type 2 diabetes mellitus
* Use of sodium/glucose cotransporter 2 (SGLT2) inhibitors
* Pregnancy and breastfeeding
* Kidney failure and moderate-to-severe chronic kidney disease
* Liver failure
* Heart failure (NYHA III-IV)
* Respiratory failure
* Unstable angina, stroke or myocardial infarction in the last 12 months
* Cardiac arrhythmias
* Eating disorders and other severe mental illnesses, alcohol and substance abuse
* Active/severe infections
* Planned elective surgery or invasive procedures
* Rare disorders: porphyria, carnitine deficiency, carnitine palmitoyltransferase deficiency, carnitine-acylcarnitine translocase deficiency, mitochondrial fatty acid β-oxidation disorders, pyruvate carboxylase deficiency
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05898204
Study Brief:
Protocol Section:
NCT05898204