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

Cairo University (CU)

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Treatments

Other: Placebo

Dietary Supplement: Vitamin K

Study type

Interventional

Funder types

Other

Identifiers

NCT04285450

CL2182

Details and patient eligibility

About

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.

Enrollment

106 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.