Effects of Oral Magnesium Supplementation on Patients With Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2021-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Type2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

Oral Magnesium Supplementation

Intervention Type DIETARY_SUPPLEMENT

250 mg of elemental magnesium daily for three months

Standard Care for diabetic patients

Intervention Type OTHER

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

Control group

This group will receive the standard care for diabetic patients

Group Type ACTIVE_COMPARATOR

Standard Care for diabetic patients

Intervention Type OTHER

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

Interventions

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Oral Magnesium Supplementation

250 mg of elemental magnesium daily for three months

Intervention Type DIETARY_SUPPLEMENT

Standard Care for diabetic patients

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No