Magnesium Supplementation in Type II Diabetes

Not Applicable

Completed

• Conditions: Effect of Magnesium in Diabetes
• Interventions: Dietary Supplement: Magnesium citrate; Dietary Supplement: Placebo

• Registration Number: NCT03002545
• Lead Sponsor: Protina Pharmazeutische GmbH

Brief Summary

This study aims to determine how a 12-week magnesium supplementation with 400 mg magnesium from organic magnesium citrate affects blood glucose control and insulin resistance within patients with type 2 diabetes (HbA1c\> 6%) and how the expression of certain Mg-sensitive transporting genes is affected .

Detailed Description

The examinations are carried out in 50 subjects aged 20-80 years with existing type 2 diabetes (HbA1c\> 6%). The target parameters are determined in the blood. Blood sampling takes place at confinement, after 6 weeks and at the end of the study (week 12). In addition, blood pressure is determined and general health condition of each subject is recorded by a standardized questionnaire (SF-36).

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-19
• Study First Submitted QC: 2016-12-20
• Study First Posted: 2016-12-23
• Primary Completion: 2019-03
• Study Completion: 2019-07
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-27
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Type II Diabetics (HbA1c > 6%)

Exclusion Criteria

• pregnancy, lactation
• persons with severe renal impairment (glomerular filtration rate <30 ml / min)
• use of insulin, oral antidiabetic drugs, diuretics, antacids or proton pump inhibitors within 4 weeks prior to study start and during the study
• intake of vitamin supplements, dietary supplements, mineral products or possibly enriched foods containing Magnesium within 4 weeks before study start and during the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnesium	Magnesium citrate	Supplementation with 400 mg Magnesium from Magnesium citrate once daily
Placebo	Placebo	identically tasting and looking Placebo

Primary Outcome Measures

Name	Time	Method
questionnaire SF-36	12 weeks	questionnaire is used to assess the physiological health Status of patients
blood sampling	12 weeks	measurement of type II Diabetes relevant Parameters including Glucose, HbA1c, HOMA-IR, magnesium-sensitive gene expression
blood pressure measurement	12 weeks	measurement of blood pressure

Trial Locations

Locations (1)

St. Anna Hospital; 🇩🇪 Herne, Germany