A Randomized, Placebo-controlled, Double Blind Trial to Investigate Whether Vitamin K2 Can Influence Arterial Calcification in Patients With Type 2 Diabetes

UMC Utrecht68 enrolled

Overview

Arterial calcification is an independent predictor of coronary events associated with a 3-4 fold increased risk of cardiovascular events. Currently, no effective intervention exists to reduce arterial calcification. However, recent studies showed that vitamin K may reduce ongoing calcium deposition in the arteries, and thereby inhibit arterial calcification. The primary objective is to determine if MK-7 supplementation leads to stabilization or attenuation of ongoing calcium deposition in the femoral artery as quantified by 18F-NaF PET/CT imaging in patients with type 2 diabetes and arterial disease.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Arterial Calcification Diabetes Mellitus Type 2

Interventions

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Middle aged men and women, ≥ 40 years. * Diagnosed with type 2 diabetes. * Presence of arterial diseases, based on an Ankle Brachial Index (ABI) \<0.9 and/or diagnosed with arterial diseases by physician. * ABI\<0.9 * Written informed consent. Exclusion Criteria: * Subjects participate in another intervention research or study using imaging. * Contra-indication for undergoing18F-NaF PET/CT scan (claustrophobia, pregnancy, breastfeeding). * Subject underwent amputation of the lower extremities (above the knee). * Using vitamin K antagonists. * Known coagulation problems (history of Venous Thrombo Embolism). * Using vitamin supplements that contain vitamin K, or unwilling to stop two weeks before randomisation. * A mean vitamin K2 intake ≥120 microgram/day measured with a questionnaire. * Natto or goose liver consumers. * Low kidney function (eGFR\<30).

Outcomes

Primary Outcomes

Absolute change in ongoing calcium deposition quantified as volumetric bone metabolic rate (CSUVMEAN x cm3) in the femoral artery between baseline and 6 months after baseline, as determined by 18F-NaF PET/CT imaging.

Time frame: 6 months