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The Clinical Effect of Vitamin K Administration in Type 2 Diabetic Patients

The Clinical Effect of Vitamin K Administration in Type 2 Diabetic Patients

Recruiting
18-65 years
All
Phase 4

Overview

The aim of this study is to examine the possible clinical effects associated with vitamin K supplementation on the glycemic control, insulin sensitivity and lipid profile of type II diabetic patients.

Eligibility

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.

Study details
    NIDDM

NCT04285450

Cairo University

16 February 2024

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