arterial calcification Arterial stiffness
Conditions
Interventions
Magnesium citrate, 350 mg daily orally for six months, versus placebo.
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: age 50-80 years; Diabetes Mellitus Type 2; Presence of a predominantly medial arterial calcification pattern on a previously conducted CT scan of the legs; Carotid-femoral pulse wave velocity higher than 12 meter per seconde; Ability to provide informed consent prior to initiating screening visit procedures.
Exclusion criteria
Exclusion criteria: Myasthenia Gravis; Use of medications that might interact with magnesium supplements (levothyroxine, osteoporosis medications tiludronate and alendronate, warfarin); Advanced diabetes complications (proliferative retinopathy, disabling polyneuropathy, nephropathy with an estimated glomerular filtration rate (eGFR), calculated with the Jaffé method according to the Chronic Kidney Disease Epidemiology Collaboration equation *2.6*mg/dL or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints are serum T50 and carotid-femoral pulse wave velocity (c-f PWV) at three and six months after baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are total magnesium, sodium, potassium, calcium, phosphate, urea, total protein, creatinine, triglycerides, total cholesterol, LDL-cholesterol, HDL-cholesterol, fasting plasma glucose and HbA1C concentrations at three and six months after baseline. | — |
Countries
Netherlands
Outcome results
None listed