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

NCT04632277 | Completed

• 1 other identifier: IRB-2019-01-407
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

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

Conditions

Diabetes Mellitus; Patients; Glucose, High Blood

Keywords

Magnesium; Diabetes mellitus; Blood samples

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (5)

• Serum Calcium

  3 months

• Urine Microalbumin

  3 months

• Serum Vitamin D

  3 months

• Blood Urea mg/dL

  3 months

• Serum Creatinine.

  3 months

Other Outcomes (3)

• Body weight

  3 months

• Body height

  3 months

• Body mass index

  3 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

A "tap water",

Other: Water

Expermental recieve low MG

EXPERIMENTAL

Low Mg bottle water (50mg/l)

Dietary Supplement: Water with low Mg

Expermental recieve high MG

EXPERIMENTAL

high Mg bottle water (100 mg/l)

Dietary Supplement: Water with high Mg

Interventions

Water OTHER

Participants will receive a tab water

Placebo

Water with low Mg DIETARY_SUPPLEMENT

Participants will receive Low Mg bottle water (50mg/l)

Expermental recieve low MG

Water with high Mg DIETARY_SUPPLEMENT

Participants will receive High Mg bottle water (100mg/l)

Expermental recieve high MG

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with type 2
• On any diabetic treatment

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

Mtalhariri@Iau.Edu.Sa

Dammam, Saudi Arabia

Location

King Fahd Hospital of the University

Khobar, 2208, Saudi Arabia

Location

Related Publications (3)

• 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.

  PMID: 12537988 BACKGROUND

• 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.

  PMID: 17645588 BACKGROUND

• 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.

  PMID: 26798400 RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Water

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: November 17, 2020
• Study Start: August 25, 2020
• Primary Completion: May 1, 2021
• Study Completion: August 1, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-09

Locations

SA (2)