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:
2025-12-26 @ 3:59 PM
Ignite Modification Date:
2025-12-26 @ 3:59 PM
NCT ID:
NCT05295706
Eligibility Criteria:
Inclusion Criteria:
* Ability to walk, sit down and stand up independently
* Family history of type 2 diabetes
* Overweight/obese status (BMI\>= 25)
* Subject is judged to be in satisfactory health based on medical history, physical examination
* Willingness and ability to comply with the protocol
* HbA1C levels are within the pre-diabetic range (5.7-6.4%) or fasting plasma glucose 100-125 mg/dL
* Access to a smartphone device and willing to use WhatsApp to communicate with research personnel
Exclusion Criteria:
* Subject has planned elective surgery requiring 2 or more days of hospitalization during the entire study
* Planned medical procedures that are documented to interfere with CGM readings, such as:
* Xylose absorption testing (oral sugar testing)
* CT
* MRI
* X-ray
* Diathermy treatment (high-frequency electric current to stimulate heat generation within body tissues)
* Established diagnosis of malignancy
* Presence of acute illness or metabolically unstable chronic illness
* Any other condition according to the PI, nurse, or study coordinator that was found during the screening visit, that would interfere with the study or safety of the patient
* Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05295706
Study Brief:
Protocol Section:
NCT05295706