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 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT06442150
Eligibility Criteria:
Inclusion Criteria:
* Physician-diagnosed T2DM
* The history of T2DM less than 6 years
* Most recent HbA1c higher than 6.5%
* Body mass index: 24-45 kg/m2
* Fasting C-p ≥1.1 ng/ml
* Inability to provide informed consent
Exclusion Criteria:
* Type 1 diabetes, type 2 diabetes currently treated with insulin, or HbA1c ≥12%
* Cardiovascular events within 6 months before trial
* Current use of anti-obesity medications, eating disorders, dieting behaviors, or weight loss \>5 kg within 6 months before trial
* Chronic kidney disease stage 3b or above (eGFR \<30 mL/min/1.73m²)
* Any condition causing fluid overload, such as heart failure or liver cirrhosis
* Previously diagnosed psychiatric disorders (e.g., schizophrenia, post-traumatic stress disorder, obsessive-compulsive disorder), uncontrolled depression, or epilepsy
* Severe arthritis or active gout
* Active gallstone disease or known as asymptomatic gallstones
* Concurrent enrollment in another clinical trial
* Pregnancy, lactation, or planned conception during the study
* Substance abuse
* Known malignancy
* Comorbidities increasing dietary intervention risk (e.g., biliary disorders)
* Long-term use of antibiotics, corticosteroids, NSAIDs, or PPIs
* Chronic gastrointestinal disorders affecting gut microbiota (e.g., ulcerative colitis)
* Severe hepatic impairment (ALT \>2.5× ULN)
* Inability to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06442150
Study Brief:
Protocol Section:
NCT06442150