Completed

Magnesium Citrate Supplementation Impact on Blood Sugar, Blood Pressure and Gene Expression in Type II Diabetes Patients

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Study Aim

This study aims to evaluate the impact of Magnesium Citrate supplementation on your blood sugar levels, blood pressure, and specific gene expression related to Type II Diabetes.

What is being tested

Magnesium citrate

+ Placebo

Dietary Supplement
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 20 to 80 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: December 2016
See protocol details

Summary

Principal SponsorProtina Pharmazeutische GmbH
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2016

Actual date on which the first participant was enrolled.

This study focuses on understanding the effects of magnesium citrate supplementation in individuals with type 2 diabetes. The research involves 50 participants aged between 20 and 80 years, all of whom have type 2 diabetes (indicated by HbA1c levels above 6%). The primary goal is to explore how a 12-week course of 400 mg magnesium citrate daily might impact blood sugar levels, blood pressure, and the expression of genes sensitive to magnesium. This research is important as it could potentially uncover new ways to manage type 2 diabetes, improving the quality of life for those affected. During the study, participants will take the magnesium citrate supplement daily. The study's progress will be tracked through blood tests at the beginning, midpoint (6 weeks), and end (12 weeks). These tests will measure relevant parameters like glucose, HbA1c, and HOMA-IR, as well as the expression of magnesium-sensitive genes. Additionally, blood pressure will be monitored and a standardized questionnaire (SF-36) will be used to assess each participant's general health condition. The study aims to provide valuable insights into the potential benefits and risks associated with magnesium citrate supplementation for individuals with type 2 diabetes.

Official TitleEffects 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
NCT03002545
Principal SponsorProtina Pharmazeutische GmbH
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

1 inclusion criteria required to participate
Type II Diabetics (HbA1c > 6%)

4 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Supplementation with 400 mg Magnesium from Magnesium citrate once daily

Group II

Placebo
identically tasting and looking Placebo

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

St. Anna Hospital

Herne, GermanyOpen St. Anna Hospital in Google Maps
CompletedOne Study Center