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Magnesium Supplementation in Type II Diabetes

Primary Purpose

Effect of Magnesium in Diabetes

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Magnesium citrate
Placebo
Sponsored by
Protina Pharmazeutische GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Effect of Magnesium in Diabetes focused on measuring Magnesium, Type II diabetes, magnesium-sensitive genes

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Anna Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Magnesium

Arm Description

identically tasting and looking Placebo

Supplementation with 400 mg Magnesium from Magnesium citrate once daily

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 19, 2016
Last Updated
August 27, 2019
Sponsor
Protina Pharmazeutische GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT03002545
Brief Title
Magnesium Supplementation in Type II Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Protina Pharmazeutische GmbH

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effect of Magnesium in Diabetes
Keywords
Magnesium, Type II diabetes, magnesium-sensitive genes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
identically tasting and looking Placebo
Arm Title
Magnesium
Arm Type
Active Comparator
Arm Description
Supplementation with 400 mg Magnesium from Magnesium citrate once daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Magnesium citrate
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
blood sampling
Description
measurement of type II Diabetes relevant Parameters including Glucose, HbA1c, HOMA-IR, magnesium-sensitive gene expression
Time Frame
12 weeks
Title
blood pressure measurement
Description
measurement of blood pressure
Time Frame
12 weeks
Title
questionnaire SF-36
Description
questionnaire is used to assess the physiological health Status of patients
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
St. Anna Hospital
City
Herne
ZIP/Postal Code
44649
Country
Germany

12. IPD Sharing Statement

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Magnesium Supplementation in Type II Diabetes

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