Magnesium Supplementation in Type II Diabetes

NCT ID: NCT03002545

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2019-07-31

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).

Conditions

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Effect of Magnesium in Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

identically tasting and looking Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Magnesium

Supplementation with 400 mg Magnesium from Magnesium citrate once daily

Group Type ACTIVE_COMPARATOR

Magnesium citrate

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Magnesium citrate

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Protina Pharmazeutische GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St. Anna Hospital

Herne, , Germany

Site Status

Countries

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Germany

Other Identifiers

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DiaMag 2017

Identifier Type: -

Identifier Source: org_study_id

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