A randomized, placebo-controlled, double blind trial to investigate whether vitamin K2 can influence ongoing calcium deposition in patients with type 2 diabetes - Vitamin K2 and arterial calcification

niversitair Medisch Centrum Utrecht0 个研究点目标入组 70 人开始时间: 待定最近更新: 2024年4月23日

研究概览

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•- 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. Arterial disease is defined as:
•* Coronary artery disease: angina pectoris, myocardial infarction, coronary revascularization (bypass surgery or angioplasty), or
•* Cerebral vascular disease: transient ischemic attack, cerebral infarction, amaurosis fugax, retinal infarction, history of carotid surgery, or
•* Peripheral artery disease: symptomatic and documented obstruction of distal arteries of the leg or surgery of the leg (percutaneous transluminal angioplasty, bypass or amputation), or
•* Abdominal aortic aneurysm: supra- / infrarenal aneurysm of the aorta (distal aorta anteroposterior diameter * 3 cm, measured with ultrasonography) or a history of AAA surgery, or,
•-Written informed consent.

•- Subjects participates in another intervention research or study using imaging.
•- Contra-indication for undergoing18F-NaF PET/CT scan (claustrophobic patients, pregnancy, breastfeeding).
•- Subject underwent amputation of the lower extremities (above the knee).
•- Using vitamin K antagonists.
•- Known coagulation problems (e.g. history of Venous Trombo Embolism, or polycythemia vera).
•- Plasma or blood donor and unwilling to stop during this intervention research.
•- Using vitamin supplements that contain vitamin K, or unwilling to stop two weeks before randomisation. If the participants use vitamin D or calcium supplements, it should be constant during the study.
•- A mean vitamin K2 intake *120 *g/day measured with a questionnaire.
•- Natto or goose liver consumers.
•- Known with low kidney function (eGFR <30)
•- Incompressible femoral artery, as diagnosed by a physician.

发起方

niversitair Medisch Centrum Utrecht