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NCT Number: NCT03002545

Magnesium Supplementation in Type II Diabetes

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 .

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Key information

Conditions

Effect of Magnesium in Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Anna Hospital

Herne, 44649, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium citrate

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. blood sampling

    Time frame: 12 weeks

    measurement of type II Diabetes relevant Parameters including Glucose, HbA1c, HOMA-IR, magnesium-sensitive gene expression

  2. blood pressure measurement

    Time frame: 12 weeks

    measurement of blood pressure

  3. questionnaire SF-36

    Time frame: 12 weeks

    questionnaire is used to assess the physiological health Status of patients

Sponsors and collaborators

Lead sponsor

Protina Pharmazeutische GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 23, 2016
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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