No registrations found.
ID
Source
Brief title
Health condition
Vitamin K, menaquinone-7, arterial calcification, dp-ucMGP, diabetes patiënts, arterial stiffness, bone metabolism.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Arterial calcifications as quantified by 18F-NaF PET/CT imaging.
Secondary outcome
- Arterial calcification in other arteries than the femoral artery as quantified by 18F-NaF PET/CT imaging.
- Bone metabolism in the lumbar spine, as quantified by 18F-NaF PET/CT imaging.
- Arterial stiffness, as quantified by pulse wave velocity measurement.
- Dpuc-MGP, as quantified using a sandwich ELISA.
Study objective
We expect that supplementation with vitamin K will attenuated or reduce ongoing calcification and will significantly reduce dp-ucMGP in patients with type 2 diabetes.
Intervention
vitamin K2 (menaquinone-7)
Sabine Zwakenberg
Huispostnummer STR 6.131 Postbus 85500
Utrecht 3508 GA
The Netherlands
+31 (0)88 75 69631
S.R.Zwakenberg@umcutrecht.nl
Sabine Zwakenberg
Huispostnummer STR 6.131 Postbus 85500
Utrecht 3508 GA
The Netherlands
+31 (0)88 75 69631
S.R.Zwakenberg@umcutrecht.nl
Inclusion criteria
- Middle aged men and women ¡Ý 40 years.
- Diagnosed with type 2 diabetes.
- At high risk of arterial calcification, based on an Ankle Brachial Index (ABI) <0.9 or ¡Ý 1.3 or diagnosed PAD (prevalence is 24% in patients with type 2 diabetes (39)).
- Written informed consent
Exclusion criteria
- Contra-indication for undergoing 18F-NaF PET/CT scan (pregnancy, breastfeeding, recent radiotherapy or chemotherapy).
- Subject underwent amputation.
- Not willing to give up blood donation during the study.
- Using vitamin K antagonists.
- Known coagulation problems (history of thrombosis).
- Using vitamin supplements that contain vitamin K, vitamin D or calcium.
- A mean vitamin K2 intake ¡Ý 120 ¦Ìg/day measured with a telephone questionnaire.
- Natto or goose liver consumers.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5147 |
| NTR-old | NTR5287 |
| CCMO | NL53572.041.15 |
| OMON | NL-OMON45148 |