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 @ 12:33 PM
Ignite Modification Date:
2025-12-24 @ 12:33 PM
NCT ID:
NCT03665961
Eligibility Criteria:
Inclusion Criteria:
* Provision of signed written informed consent,
* Aged between 21- 75 years old,
* Body Mass Index (BMI) of \> 18 kg/m2,
* Ethnic group of either Chinese, Malay or Indian as evidenced by identification card,
* Subject with absence of impaired glucose tolerance,
* Subject is healthy with no clinically significant disease or condition as determined through their medical history, physical examination; Diabetes mellitus was defined as Type 2 DM fulfilling the WHO criteria and the care of Department of Endocrinology, Changi General Hospital,
* Ability to communicate with investigator and to understand and comply with all requirements of study participation.
Exclusion Criteria:
* Subject who are viral Hepatitis (B or C) or HIV positive as per declaration,
* Subject who had bariatric surgery including lap banding, gastric sleeve surgery, cholecystectomy,
* Subject who has \> 5% weight loss in the last 3 months prior to study enrolment as per declaration,
* Subject who are on 'stable' insulin sensitizers such as such as rosiglitazone, metformin for the last 3 months prior to enrolment,
* Pregnant women,
* Subject who has been treated with antibiotics within 6 weeks of enrolment,
* Subject who has usage of lactulose, dietary fibres for purpose of constipation,
* Subject with immune-compromised status; undergoing chemotherapy, on steroid,
* Subject with FMHx or PMHx of autoimmune disease, GI cancers, inflammatory bowel disease, Irritable bowel syndrome and anxiety or depression as per declaration.
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT03665961
Study Brief:
Protocol Section:
NCT03665961