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

• ClinicalTrials.gov Identifier: NCT04632277
• Recruitment Status: Completed
• First Posted: November 17, 2020
• Last Update Posted: September 29, 2021
• Sponsor: Imam Abdulrahman Bin Faisal University
• Collaborator: The Saline Water Conversion Corporation Research Institute at Al-Jubail, KSA.
• Information provided by (Responsible Party): MOHAMMED ALHARIRI, Imam Abdulrahman Bin Faisal University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus; Patients; Glucose, High Blood	Other: Water; Dietary Supplement: Water with low Mg; Dietary Supplement: Water with high Mg	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 102 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Daily Intake of Magnesium From Drinking Water in Relation to Diabetes Mellites
• Actual Study Start Date: August 25, 2020
• Actual Primary Completion Date: May 1, 2021
• Actual Study Completion Date: August 1, 2021

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. Magnesium (Mg). [ Time Frame: 3 months ]
   Serum Mg mg/dL. Baseline and 3 months
2. Fasting blood glucose [ Time Frame: 3 months ]
   Fasting blood glucose mg/dL. Baseline and 3 months
3. Insulin μIU/mL [ Time Frame: 3 months ]
   Serum Insulin μIU/mL. Baseline and 3 months
4. HbA1c [ Time Frame: 3 months ]
   HbA1c. Baseline and 3 months
5. Serum HDL (high-density lipoprotein) [ Time Frame: 3 months ]
   Serum HDL mg/dL. Baseline and 3 months
6. Serum LDL (low-density lipoprotein) [ Time Frame: 3 months ]
   Serum LDL mg/dL. Baseline and 3 months
7. Serum Triglycerides [ Time Frame: 3 months ]
   Serum Triglycerides mg/dL. Baseline and 3 months
8. Serum Cholesterol [ Time Frame: 3 months ]
   Serum Cholesterol mg/dL. Baseline and 3 months

Secondary Outcome Measures :

1. Serum Calcium [ Time Frame: 3 months ]
   Ca md/dL. Baseline and 3 months
2. Urine Microalbumin [ Time Frame: 3 months ]
   microalbuminurea (30-300 mcg/mg creatinine). Baseline and 3 months
3. Serum Vitamin D [ Time Frame: 3 months ]
   Vit D ng/mL. Baseline and 3 months
4. Blood Urea mg/dL [ Time Frame: 3 months ]
   Baseline and 3 months
5. Serum Creatinine. [ Time Frame: 3 months ]
   Baseline and 3 months (mg/dL)

Other Outcome Measures:

1. Body weight [ Time Frame: 3 months ]
   weight in kilograms. Baseline and 3 months
2. Body height [ Time Frame: 3 months ]
   height in meters. Baseline and 3 months
3. Body mass index [ Time Frame: 3 months ]
   Weight in kilograms divided by the square of height in meters. Baseline and 3 months

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

Saudi Arabia

Mtalhariri@Iau.Edu.Sa

Dammam, Saudi Arabia

King Fahd Hospital of the University

Khobar, Saudi Arabia, 2208

Sponsors and Collaborators

Imam Abdulrahman Bin Faisal University

The Saline Water Conversion Corporation Research Institute at Al-Jubail, KSA.

More Information

Publications of Results:

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.

Other 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. Review.

Larsson SC, Wolk A. Magnesium intake and risk of type 2 diabetes: a meta-analysis. J Intern Med. 2007 Aug;262(2):208-14. Review.

• Responsible Party: MOHAMMED ALHARIRI, Principal Investigator, Imam Abdulrahman Bin Faisal University
• ClinicalTrials.gov Identifier: NCT04632277
• Other Study ID Numbers: IRB-2019-01-407
• First Posted: November 17, 2020
• Last Update Posted: September 29, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: No plan to share the results

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by MOHAMMED ALHARIRI, Imam Abdulrahman Bin Faisal University:

Magnesium; Diabetes mellitus; Blood samples

Additional relevant MeSH terms:

Diabetes Mellitus; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases