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

Phase 2

Completed

Conditions: Arterial calcification
cardiovascular disease
10003216

Registration Number: NL-OMON45148

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 70

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. 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.

Exclusion Criteria

- 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Ongoing calicum deposition in the femoral artery, quantified by 18F-NaF PET/CT<br /><br>imaging. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Ongoing calcium deposition in other arteries than the femoral artery, as<br /><br>quantified by 18F-NaF PET/CT imaging<br /><br>- Ongoing calcium deposition in the lumbar spine, as quantified by 18F-NaF<br /><br>PET/CT imaging<br /><br>- Arterialstiffness, as quantified by pulsecor.<br /><br>- Dpuc-MGP, as quantified using a sandwich ELISA.</p><br>