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 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT05375656
Eligibility Criteria:
Inclusion Criteria:
* Homozygous carriers of the c.273\_274delAG variant in the SI-gene (cases)
* Homozygous non-carriers of the c.273\_274delAG variant in the SI-gene (controls)
Exclusion Criteria:
* Diagnosis of diabetes or pharmacological treatment of diabetes.
* Gastrointestinal diseases such as inflammatory bowel disease, gastrointestinal cancer, and ulcer. Persons with mild gastrointestinal problems are not excluded, e.g. persons with lactose-intolerance who normally do not have any gastrointestinal problems.
* Homozygous carriers of the TBC1D4 risk variant p.Arg684Ter.
* Lack of compliance with the procedures in the study protocol, judged by Investigator.
* For the homozygous carriers of the c.273\_274delAG variant: rise in blood glucose in an oral sucrose tolerance test.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05375656
Study Brief:
Protocol Section:
NCT05375656