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CompletedNCT03002545Updated Aug 28, 2019

Magnesium Supplementation in Type II Diabetes

An interventional study of Magnesium citrate and Placebo in Effect of Magnesium in Diabetes, sponsored by Protina Pharmazeutische GmbH. Completed at 1 site in Germany. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-08-28.

Sponsored by Protina Pharmazeutische GmbH · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study 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 .

Read the 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).

02

Conditions studied

  • Effect of Magnesium in Diabetes

Keywords

  • Magnesium
  • Type II diabetes
  • magnesium-sensitive genes
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 50 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Protina Pharmazeutische GmbH is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Type II Diabetics (HbA1c > 6%)

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
50 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    identically tasting and looking Placebo

    Dietary Supplement: Placebo

  • Active comparator
    Magnesium

    Supplementation with 400 mg Magnesium from Magnesium citrate once daily

    Dietary Supplement: Magnesium citrate

Interventions

06

What researchers measure

Primary outcomes

  1. blood sampling

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

    Time frame: 12 weeks

  2. blood pressure measurement

    measurement of blood pressure

    Time frame: 12 weeks

  3. questionnaire SF-36

    questionnaire is used to assess the physiological health Status of patients

    Time frame: 12 weeks

07

Study locations

1 site
  • St. Anna Hospital
    Herne, 44649, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03002545
Lead sponsor
Protina Pharmazeutische GmbH
Responsible party
Sponsor
First posted
Dec 23, 2016
Start date
Dec 2016
Primary completion
Mar 2019
Completion
Jul 2019
Last update
Aug 28, 2019
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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