Diabetes Mellitus, Type 2
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTVitamin K
1mg
OTHERPlacebo
Lactose
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Homeostasis model assessment of insulin resistance (HOMA-IR) | 24 weeks |
Countries
Egypt
Outcome results
None listed