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:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 12:18 AM
NCT ID:
NCT06439758
Eligibility Criteria:
Inclusion Criteria:
* Consenting Saudi adults, males, and females, aged 25-65 years with newly diagnosed T2DM will be included.
* T2DM diagnosis will be done by collaborating primary care physicians following the American Diabetes Association (ADA) and World Health Organization (WHO) criteria (ADA, 2022):
* Fasting plasma glucose ≥7.0mmol/l or ≥126mg/dl. Fasting is defined as no caloric intake for at least 8 hours OR
* 2-h PG ≥200 mg/dl (11.1 mmol/L) during OGTT. The test should be performed as described by WHO, using a glucose load containing the equivalent of 75g anhydrous glucose dissolved in water.
OR •Hba1c ≥6.5% (48 mmol/mol). The test should be performed in a laboratory using a method that is National Glycohemoglobin Standardization Program (NGSP) certified and standardized to the Diabetes Control and Complications (Trial) DCCT assay.
OR
•In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥200 mg/dl (11.1 mmol/L).
Exclusion Criteria:
* Non-Saudis and those outside the age range (less than 25 years and above 65 years old).
* Those with comorbidities and existing complications (osteoporosis, uncontrolled hypertension, atherosclerosis, renal and liver abnormalities, morbidly obese, psychologically incapacitated).
* Known cases of T2DM who are already on medications.
* Participants who will be unable to commit to the treatment allocated for 6 months, either for personal reasons or physician's advice.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT06439758
Study Brief:
Protocol Section:
NCT06439758