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NCT Number: NCT04636411

Effects of Oral Magnesium Supplementation on Patients With Type 2 Diabetes

A total of 74 Adult Patients with type 2 diabetes mellitus (T2D) will be enrolled and randomized into 2 groups. The intervention group will receive oral magnesium (Mg) supplementation. The study objectives are:

1. To estimate level of Mg (total and ionized) in patient with type 2 DM. 2. To determine the effect of Mg supplementation for diabetic patient on serum Mg level, glycemic control and level of inflammation. 3. To assess the correlation between serum Mg level and glycemic control and level of inflammatory mediators (CRP)

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Key information

Conditions

Type2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Inflammation Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mokattam primary health care unit

Cairo, Mokattam, 11562, Egypt

About this study

A total of 74 Adult Patients of both genders who had been diagnosed with T2D and are on oral anti-hyperglycemic drug and their HbA1C between 7and 8 %, will be enrolled in the study. Initially the study protocol will be explained & informed written consent will be obtained from all participants. All subjects will be evaluated to ensure that they meet the eligibility criteria through: Full history taking, complete physical examination and investigations. the intervention group will receive oral magnesium (Mg) supplementation for 3 months (250 mg of elemental magnesium daily). The primary outcome is to determine the effect of Mg supplementation for diabetic patient on serum Mg level, glycemic control and level of inflammation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with type 2 diabetes with HbA1C between 7 and 8%.
  • Both genders will be included in this study.

Exclusion criteria

  • Patients on insulin.
  • Patients on diuretics or angiotensin-converting enzyme inhibitors in the last 2 weeks.
  • Patients taking Mg containing supplements within 3 months.
  • Patients with significant gastrointestinal disorders (eg, chronic diarrhea).
  • Patients with impaired renal functions (eGFR< 60 mL/min).
  • Heart block or heart failure
  • Patients treated with aldosterone antagonists.
  • Pregnant patients
  • Patients with evidence of infection.
  • Patients with chronic inflammatory conditions eg, SLE

Treatment and study plan

Oral Magnesium Supplementation

Dietary Supplement

250 mg of elemental magnesium daily for three months

Standard Care for diabetic patients

Other

Health education, oral antihyperglycemic medications according to American Diabetes Association (ADA) guidelines

Primary outcomes

  1. Glycemic control

    Time frame: 3 months

    To determine the effect of oral Mg supplementation for diabetic patient on Glycemic control

  2. Inflammation

    Time frame: 3 months

    To determine the effect of oral Mg supplementation for diabetic patient on inflammation (CRP)

Secondary outcomes

  1. Serum magnesium level

    Time frame: 3 months

    To determine the effect of Mg supplementation for diabetic patient on serum Mg level

  2. Prevalence of hypomagnesemia

    Time frame: up to 4 weeks

    To estimate prevalence of hypomagnesemia in patients with type 2 DM.

  3. Correlation of serum Mg level

    Time frame: up to 4 weeks

    To assess the correlation between serum Mg level and glycemic control and level of inflammatory mediators (CRP).

  4. Total or ionized Mg

    Time frame: 3 months

    Determine the more accurate measure for Mg in diabetic patient either total or ionized Mg

Sponsors and collaborators

Lead sponsor

Samar Fares, MD

Other

Collaborators

  • Marwa Mostafa Ahmed
  • Moushira Hosny Ezzelarab Sayed
  • Nagwa Eid Sobhy Saad
  • Walaa Reda Abdel Fattah Mohamed Badr

Registry information

Official study title

Evaluation of the Effects of Oral Magnesium Supplementation on Glycemic Control and Inflammation Among Patients With Type 2 Diabetes

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 19, 2020
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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