Magnesium supplementation as a strategy to reduce serum calcification propensity and vascular stiffness in people with type 2 diabetes: a double-blind, randomized, placebo-controlled parallel trial

Amsterdam UMC Location VUmc0 个研究点目标入组 74 人开始时间: 2023年7月28日最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•1. Age 50-80 years
•3. Presence of a predominantly MAC pattern on the CT scan
•4. c-f PWV >12 m/s
•5. Ability to provide informed consent prior to initiating screening visit procedures

•1. Myasthenia gravis
•2. Use of medications that might interact with magnesium supplements (levothyroxine, osteoporosis medications tiludronate and alendronate, warfarin)
•3. Advanced diabetes complications:
•3.1. Proliferative retinopathy
•3.2. Disabling polyneuropathy
•3.3. Nephropathy with an estimated glomerular filtration rate (eGFR), calculated with the Jaffé method according to the Chronic Kidney Disease Epidemiology Collaboration equation <15 ml/min/1.73 m² or chronic dialysis
•3.4. cardiac complications
•4. Uncontrolled hyperthyroidism or active parathyroid disease
•5. Chronic diarrheal disease or inflammatory bowel diseases
•6. Congestive heart failure, bradycardia with a resting heart rate below 60 mmHg and systolic blood pressure less than 90 mmHg
•7. Atrial fibrillation
•8. Previous aortic surgery
•9. Severe hepatic insufficiency
•10. Malignancy or other non-cardiac conditions limiting life expectancy to <3 years
•11. Using food supplements that contain magnesium, or unwilling to stop 2 weeks before randomization
•12. Mental or legal incapacitation to provide informed consent
•13. Plasma magnesium concentration <1.5 mg/dl or >2.6 mg/dl at screening

发起方

Amsterdam UMC Location VUmc