Magnesium Supplementation in Type II Diabetes

Effect of Magnesium in Diabetes Clinical Trial

Official title:

Effects of a 12-week Supplementation With 400 mg Magnesium From Magnesium Citrate on Blood Sugar, Blood Pressure and Expression of Magnesium-sensitive Genes in Patients With Type II Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03002545
• Other study ID #: DiaMag 2017
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: July 2019

Study information

• Verified date: August 2019
• Source: Protina Pharmazeutische GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Effect of Magnesium in Diabetes

Intervention

Dietary Supplement:
• Magnesium citrate

• Placebo

Locations

Country	Name	City	State
Germany	St. Anna Hospital	Herne

Sponsors (1)

Lead Sponsor	Collaborator
Protina Pharmazeutische GmbH

Country where clinical trial is conducted

Germany, 

Outcome

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