Effects of Oral Magnesium Supplementation on Patients With Type 2 Diabetes

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

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.

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

Conditions
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Type2 Diabetes

Intervention / Treatment
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* Dietary Supplement: Oral Magnesium Supplementation
* Other: Standard Care for diabetic patients


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study participants will be randomized into 2 groups (intervention and control group) to be studied simultaneously
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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<br>* 250 mg of elemental magnesium daily for three months<br>Other: Standard Care for diabetic patients<br>* Health education, oral antihyperglycemic medications according to American Diabetes Association (ADA) guidelines<br>|
| Active Comparator: Control group<br>This group will receive the standard care for diabetic patients | Other: Standard Care for diabetic patients<br>* Health education, oral antihyperglycemic medications according to American Diabetes Association (ADA) guidelines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum magnesium level | To determine the effect of Mg supplementation for diabetic patient on serum Mg level | 3 months | 
| Prevalence of hypomagnesemia | To estimate prevalence of hypomagnesemia in patients with type 2 DM. | up to 4 weeks | 
| Correlation of serum Mg level | To assess the correlation between serum Mg level and glycemic control and level of inflammatory mediators (CRP). | up to 4 weeks | 
| Total or ionized Mg | Determine the more accurate measure for Mg in diabetic patient either total or ionized Mg | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral Magnesium, Type 2 Diabetes, Diabetes Control, HbA1c, Inflammation