Magnesium Supplementation in Type II Diabetes

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Effect of Magnesium in Diabetes

Intervention / Treatment
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* Dietary Supplement: Magnesium citrate
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>identically tasting and looking Placebo | Dietary Supplement: Placebo<br> <br> |
| Active Comparator: Magnesium<br>Supplementation with 400 mg Magnesium from Magnesium citrate once daily | Dietary Supplement: Magnesium citrate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnesium, Type II diabetes, magnesium-sensitive genes