Effects of Oral Magnesium Supplementation on Patients With Type 2 Diabetes

NCT04636411 | Completed Phase 3 DMC

• 1 other identifier: MD-164-2020
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type2 Diabetes

Keywords

Oral Magnesium; Type 2 Diabetes; Diabetes Control; HbA1c; Inflammation

Outcome Measures

Primary Outcomes (2)

• Glycemic control

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

  3 months

• Inflammation

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

  3 months

Secondary Outcomes (4)

• Serum magnesium level

  3 months

• Prevalence of hypomagnesemia

  up to 4 weeks

• Correlation of serum Mg level

  up to 4 weeks

• Total or ionized Mg

  3 months

Study Arms (2)

Intervention group

EXPERIMENTAL

This group group will receive oral magnesium supplementation (250 mg of elemental magnesium daily for three months) plus the standard care for diabetic patients

Dietary Supplement: Oral Magnesium Supplementation; Other: Standard Care for diabetic patients

Control group

ACTIVE COMPARATOR

This group will receive the standard care for diabetic patients

Other: Standard Care for diabetic patients

Interventions

Oral Magnesium Supplementation DIETARY_SUPPLEMENT

250 mg of elemental magnesium daily for three months

Intervention group

Standard Care for diabetic patients OTHER

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

Control group; Intervention group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samar Fares, MD: lead
• Walaa Reda Abdel Fattah Mohamed Badr: collaborator
• Marwa Mostafa Ahmed: collaborator
• Moushira Hosny Ezzelarab Sayed: collaborator
• Nagwa Eid Sobhy Saad: collaborator

Study Sites (1)

Mokattam primary health care unit

Cairo, Mokattam, 11562, Egypt

Location

Related Publications (2)

• Saeed H, Haj S, Qasim B. Estimation of magnesium level in type 2 diabetes mellitus and its correlation with HbA1c level. Endocrinol Diabetes Metab. 2018 Nov 2;2(1):e00048. doi: 10.1002/edm2.48. eCollection 2019 Jan.

  PMID: 30815575 BACKGROUND

• Dhawan S, Natarajan R. Epigenetics and Type 2 Diabetes Risk. Curr Diab Rep. 2019 Jun 27;19(8):47. doi: 10.1007/s11892-019-1168-8.

  PMID: 31250127 BACKGROUND

Related Links

• Estimation of magnesium level in type 2 diabetes mellitus and its correlation with HbA1c level
• Epigenetics and Type 2 Diabetes Risk

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Inflammation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Nagwa E Saad, Professor

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of family medicine

Model Details: The study participants will be randomized into 2 groups (intervention and control group) to be studied simultaneously

Study Record Dates

• First Submitted: November 8, 2020
• First Posted: November 19, 2020
• Study Start: November 1, 2020
• Primary Completion: October 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After finalizing the study
• Access Criteria: The study data will be available upon reasonable request from central contact person

Locations

EG (1)