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

  • STATUS
    Recruiting
  • participants needed
    99
  • sponsor
    Cairo University
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Updated on 16 February 2024
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fasting
insulin sensitivity
vitamin
fasting blood glucose
clotting
glucose concentration
type ii diabetes

Summary

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.

Details
Condition NIDDM
Age 18years - 65years
Treatment Placebo, Vitamin K
Clinical Study IdentifierNCT04285450
SponsorCairo University
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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