Effect of oral magnesium supplementation on insulin sensitivity in people with type 2 diabetes

Phase 4

Completed

Conditions: Type 2 diabetes mellitus
10018424

Registration Number: NL-OMON50922

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 14

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

* 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 < 45 ml/min/1.73m2
* Body-Mass Index < 18 or > 40 kg/m2
* Pregnancy or the wish to become pregnant

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the change in insulin sensitivity after oral<br /><br>magnesium supplementation measured by the mean glucose infusion rate during the<br /><br>last 30 minutes of the hyperinsulinemic euglycemic glucose clamp. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include the effect of oral magnesium supplementation on<br /><br>HbA1c, insulin dose requirements, symptoms associated with hypomagnesemia,<br /><br>blood pressure, physical activity and glucose-, lipid and inflammatory profile.<br /><br>Additionally, we will explore the differences in glycemic control, lipid<br /><br>profile and blood pressure between people with T2DM and normo- versus<br /><br>hypomagnesemia.</p><br>