Is Mg do Improve the Glycemic Control in Patients Drink a Desalinate Water (Mg)

Daily Intake of Magnesium From Drinking Water in Relation to Diabetes Mellites

Background and aim:

Diabetes mellitus as a chronic disease is on rise on parallel with diseases. Magnesium (Mg) supplementation may help control glycemic response among type 2 diabetes (T2D) patients. We aim to present an overview of the possible influence of drinking water in general and mineral water in particular in improving glycemic parameters in persons with type 2 diabetes.

Method:

A randomized double blind controlled clinical trial will be conducted at the Endocrine clinic (KFHU) on 900 of patients with T2DM. All subjects participated in this study will be randomly allotted into three groups (each group N=300) to which the three waters were supplied in similar bottles marked A "tap water", B "bottle water" and C "control without any intervention".

Blood samples will be taken before and after the intervention to determine the serum concentration of magnesium, Calcium, Vit D, creatinine, FBS, serum Ca, HbA1c, fasting C-peptide levels, fasting insulin levels and insulin sensitivity. Magnesium and calcium levels in urine will be expressed as the creatinine ratio

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Glucose, High Blood; Patients
• Intervention / Treatment: Other: Water; Dietary supplement: Water with low Mg; Dietary supplement: Water with high Mg

Detailed Description

Study population and design:

A randomized double blind controlled clinical trial will be conducted at the Endocrine clinic (KFHU) on 900 of patients with T2DM. This sample size was calculated at confidence interval of 95%. for the total diabetic outpatients in Endocrine clinic at KFHU during the period October 2020-May 2021.

All subjects living in the 3 catchment areas (Dammam. Khobar and Dhahran) in the eastern province before inclusion were selected.

Intervention All subjects participated in this study will be randomly (double-blind) allotted into three groups (each group N=300) to which the three waters were supplied in similar bottles marked A "tap water", B "Low Mg bottle water (50mg/l)" and C " high Mg bottle water (100 mg/l)". These doses have been chosen according to the guideline of WHO.

All patients will be asked to consume at least one liter of water/day. When preparing coffee and tea, ordinary tap water could be used. The intervention will be lasted for lasted 3 months. None of the participants will be changed their normal dietary habits during the trial.

The mean values of all the studied parameters will be checked before starting the protocol for standardization of the protocol situp of the participants. Moreover, the diary magnesium intake will be calculated by a dietitian and all the influential factors such as, demographic factors, baseline 25(OH)D, Vit D and calcium intake, Oestrogen use and sun exposure will be controlled and monitored during the research.

Inclusion criteria:

All patients with type 2 on any diabetic treatment aged 20-85 years old with hypomagnesemia (less than 0.6 mmol/L (1.46 mg/dL).

Exclusion criteria:

Type 1 diabetic patients, pregnant women, patients who use of immunosuppressive, corticosteroids, and non-steroidal anti-inflammatory, patients who have renal dysfunction or doing dialysis,

Sampling and data collection:

All participants will be seated in air-conditioned rooms and had 10-15 min of rest before measurements were taken. After signing the consent form, the demographic and clinical data of all subjects will be record including: address, education level, smoking, age, sex; and body weight and height were measured to calculate body mass index (BMI). The average of three consecutive blood pressure readings with intervals of 5-min rest will be obtained, using an electronic sphygmomanometer. All measurements and indicators will be taken at the base line and after three months of intervention.

Blood and urine samples Blood samples will be taken before and after the intervention to determine the serum concentration of serum magnesium, Calcium, Phosphorus, Vit D, creatinine, Urea, Lipid profile, Uric acid, Liver function test, Fasting blood glucose, HbA1c, fasting C-peptide levels, fasting insulin levels and insulin sensitivity. The HOMA-IR will be calculated according to the following formulas: HOMA-IR = (glucose mg x insulin level)/405. Blood samples will be collected before and after the intervention period. A sample of urine will be collected to measure Microalbuminuria. The analysis will be performed at the central laboratory, KFHU.

Research ethics:

Ethical approved and performed under the guideline of the research ethics committee of Imam Abdulrahman Bin Faisal University, Saudi Arabia and written consent will be obtained from all subjects.

Statistical analysis:

The data was entered into an SPSS. The data analysis will be divided into two steps: Descriptive statistics and analysis of variance. The quantitative data will be represented in the form of proportions (%) and of means with standard deviations. The one-way ANOVA will be used to measure the changes between groups.

Funds details:

This project will be supported by The Saline Water Conversion Corporation Research Institute at Al-Jubail, KSA.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Dammam, Saudi Arabia
    • Mtalhariri@Iau.Edu.Sa
  • Khobar, Saudi Arabia, 2208
    • King Fahd Hospital of the University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients with type 2
• On any diabetic treatment

Exclusion criteria:

• Type 1 diabetic Delete repeated word
• Pregnant women
• Patients who use of immunosuppressive, corticosteroids, and non-steroidal anti-inflammatory.
• Patients who have renal dysfunction or doing dialysis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; A "tap water",	Other: Water; Participants will receive a tab water
Experimental: Expermental recieve low MG; Low Mg bottle water (50mg/l)	Dietary supplement: Water with low Mg; Participants will receive Low Mg bottle water (50mg/l)
Experimental: Expermental recieve high MG; high Mg bottle water (100 mg/l)	Dietary supplement: Water with high Mg; Participants will receive High Mg bottle water (100mg/l)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Magnesium (Mg).	Serum Mg mg/dL. Baseline and 3 months	3 months
Fasting blood glucose	Fasting blood glucose mg/dL. Baseline and 3 months	3 months
Insulin μIU/mL	Serum Insulin μIU/mL. Baseline and 3 months	3 months
HbA1c	HbA1c. Baseline and 3 months	3 months
Serum HDL (high-density lipoprotein)	Serum HDL mg/dL. Baseline and 3 months	3 months
Serum LDL (low-density lipoprotein)	Serum LDL mg/dL. Baseline and 3 months	3 months
Serum Triglycerides	Serum Triglycerides mg/dL. Baseline and 3 months	3 months
Serum Cholesterol	Serum Cholesterol mg/dL. Baseline and 3 months	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Calcium	Ca md/dL. Baseline and 3 months	3 months
Urine Microalbumin	microalbuminurea (30-300 mcg/mg creatinine). Baseline and 3 months	3 months
Serum Vitamin D	Vit D ng/mL. Baseline and 3 months	3 months
Blood Urea mg/dL	Baseline and 3 months	3 months
Serum Creatinine.	Baseline and 3 months (mg/dL)	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	weight in kilograms. Baseline and 3 months	3 months
Body height	height in meters. Baseline and 3 months	3 months
Body mass index	Weight in kilograms divided by the square of height in meters. Baseline and 3 months	3 months

Collaborators and Investigators

• Sponsor: Imam Abdulrahman Bin Faisal University
• Collaborators: The Saline Water Conversion Corporation Research Institute at Al-Jubail, KSA.

Publications and helpful links

General Publications

• Barbagallo M, Dominguez LJ, Galioto A, Ferlisi A, Cani C, Malfa L, Pineo A, Busardo' A, Paolisso G. Role of magnesium in insulin action, diabetes and cardio-metabolic syndrome X. Mol Aspects Med. 2003 Feb-Jun;24(1-3):39-52. doi: 10.1016/s0098-2997(02)00090-0.
• Larsson SC, Wolk A. Magnesium intake and risk of type 2 diabetes: a meta-analysis. J Intern Med. 2007 Aug;262(2):208-14. doi: 10.1111/j.1365-2796.2007.01840.x.
• Murakami S, Goto Y, Ito K, Hayasaka S, Kurihara S, Soga T, Tomita M, Fukuda S. The Consumption of Bicarbonate-Rich Mineral Water Improves Glycemic Control. Evid Based Complement Alternat Med. 2015;2015:824395. doi: 10.1155/2015/824395. Epub 2015 Dec 21.

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2020
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: September 3, 2020
• First Submitted That Met QC Criteria: November 10, 2020
• First Posted (Actual): November 17, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Diabetes mellitus; Magnesium; Blood samples
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: IRB-2019-01-407

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: No plan to share the results

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No