The effect of a magnesium supplement on arterial calcification and arterial stiffness in individuals with type 2 diabetes
- Conditions
- Vascular stiffness in people with type 2 diabetesCirculatory System
- Registration Number
- ISRCTN60460377
- Lead Sponsor
- Amsterdam UMC Location VUmc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 74
1. Age 50-80 years
2. T2D
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method