Type 2 diabetes mellitus
Conditions
Interventions
Participants will receive placebo or magnesium gluconate drink 50 ml three
times a day (i.e. total daily magnesium dose of 15 mmol) for six weeks in a
randomized cross-over design. After both treatm
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Clinical diagnosis of type 2 diabetes mellitus * Treatment with insulin for at least one year * Minimum age of 18 years * Ability to provide informed consent
Exclusion criteria
Exclusion criteria: * Treatment with more than 7.5 mg prednisone daily (or a comparable dose of other oral corticosteroids) * Use of magnesium supplementation in the week before screening * Any cardiovascular event in the six months before screening * Illnesses and unstable diseases that interfere with the primary outcome * Chronic diarrhea * Alcohol consumption of more than 14 units weekly * MDRD-GFR 40 kg/m2 * Pregnancy or the wish to become pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the change in insulin sensitivity after oral magnesium supplementation measured by the mean glucose infusion rate during the last 30 minutes of the hyperinsulinemic euglycemic glucose clamp. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the effect of oral magnesium supplementation on HbA1c, insulin dose requirements, symptoms associated with hypomagnesemia, blood pressure, physical activity and glucose-, lipid and inflammatory profile. Additionally, we will explore the differences in glycemic control, lipid profile and blood pressure between people with T2DM and normo- versus hypomagnesemia. | — |
Countries
Netherlands
Outcome results
None listed