Magnesium Supplementation as a Strategy to Reduce Serum Calcification Propensity and Vascular Stiffness in People with Type 2 Diabetes.

Recruiting

• Conditions: arterial calcification; Arterial stiffness; 10012653; 10003216

• Registration Number: NL-OMON53724
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 74

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

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 <15 mL/min/1.73m2 or chronic
dialysis, cardiac complications);
Uncontrolled hyperthyroidism or active parathyroid disease;
Chronic diarrheal disease or inflammatory bowel diseases;
Congestive heart failure, bradycardia with a resting heart rate below 60 and
systolic blood pressure less than 90 mmHg;
Atrial Fibrillation;
Previous aortic surgery;
Severe hepatic insufficiency;
Malignancy or other non-cardiac conditions limiting life expectancy to <3 years;
Using food supplements that contain magnesium, or unwilling to stop two weeks
before randomization;
Mental or legal incapacitation to provide informed consent;
Plasma magnesium concentration*>*2.6*mg/dL or < 1.5 mg/dL at screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified