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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT06921304
Eligibility Criteria:
Inclusion Criteria
* Diagnosis of Graves' disease in an endocrinology setting based on the presence of thyrotoxicosis and positive TRAb antibodies.
* Diagnosis of Graves' disease within 1 month prior to randomization.
* BMI \> 16 kg/m² and \< 35 kg/m² at the time of the first visit for Graves' disease.
* Age \> 18 years.
* Ability to commit to the duration of the study.
* Ability to provide informed consent and willingness to participate in the study.
Exclusion Criteria
* Relapse of Graves' disease or thyrotoxicosis not related to Graves' disease.
* Any serious cardiovascular or renal event in the last 6 months.
* Current pregnancy, breastfeeding, or planning pregnancy during the study period.
* Any condition potentially leading to fluid overload such as heart failure (NYHA class \> I) or liver cirrhosis.
* Previously diagnosed significant psychiatric disorder (e.g., schizophrenia, post-traumatic stress disorder, obsessive-compulsive disorder).
* Active eating disorder.
* Uncontrolled depression.
* Uncontrolled epilepsy.
* Known cause of malabsorption (including uncontrolled celiac disease, lactose intolerance, or inflammatory bowel disease).
* Ongoing therapy with weight-modifying medications (e.g., GLP-1 analogs, metformin).
* Estimated BMI before disease onset \< 18 kg/m². This parameter will be calculated based on the "estimated pre-disease body weight" as reported by the patient.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06921304
Study Brief:
Protocol Section:
NCT06921304