Effects of Oral Magnesium Supplementation on Patients With Type 2 Diabetes

Samar Fares, MD

Status and phase: Completed; Phase 3

Conditions: Type2 Diabetes

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04636411

MD-164-2020

Details and patient eligibility

About

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)

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Intervention group

Experimental group

Description:

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

Treatment:

Other: Standard Care for diabetic patients

Dietary Supplement: Oral Magnesium Supplementation

Control group

Active Comparator group

Description:

This group will receive the standard care for diabetic patients

Treatment:

Other: Standard Care for diabetic patients