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 sites70 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

niversitair Medisch Centrum Utrecht

•\- 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\)

Not specified