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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Placebo; Dietary Supplement: Vitamin K

• Registration Number: NCT04285450
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-17
• Study Start: 2019-10-27
• Study First Submitted QC: 2020-02-25
• Study First Posted: 2020-02-26
• Primary Completion: 2022-03-01
• Study Completion: 2022-05-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-21
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	-
Vitamin K 1mg	Vitamin K	-

Primary Outcome Measures

Name	Time	Method
Homeostasis model assessment of insulin resistance (HOMA-IR)	24 weeks

Trial Locations

Locations (1)

Kasr Al Aini Hospital; 🇪🇬 Cairo, Egypt