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 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT04285450
Eligibility Criteria:
Inclusion Criteria:
* Adult patients 21-65 years old diagnosed with Type II diabetes.
* Fasting blood glucose concentration ≥ 126 mg/dL .
* Normal liver Function tests defined as ALT levels up to 33 U/L for males and up to 25 U/L for females, Albumin levels ≥ 3.5 g/dL, Bilirubin up to 1.1 mg/dL .
* Normal clotting function defined as defined by INR.
* Normal kidney function defined as serum creatinine values up to 1.3 mg/dL.
Exclusion Criteria:
* Type I diabetic patients.
* Use of supplements with potential effect on vitamin K level namely supplements containing vitamin K, co-enzyme Q10 or vitamin E \> 400 IU .
* Patients requiring anti-coagulant therapy including patients with prosthetic valves, mitral tissues, DVT, PE, atrial fibrillation and valvular heart disease.
* Patient with history of coagulation, MI, stroke and embolization.
* Pregnant or breast feeding women.
* Being on hormonal therapy or receiving contraceptive pills.
* Patients treated with glucocorticoids, thiazide diuretics, and atypical antipsychotics.
* Patients on cholestyramine, antibiotics and coumarins.
* Patients on lipid lowering agents.
* Known intestinal malabsorption syndrome, cholestasis or steatorrhea.
* Smokers.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04285450
Study Brief:
Protocol Section:
NCT04285450