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| Name | Class |
|---|---|
| Walaa Reda Abdel Fattah Mohamed Badr | UNKNOWN |
| Marwa Mostafa Ahmed | UNKNOWN |
| Moushira Hosny Ezzelarab Sayed | UNKNOWN |
| Nagwa Eid Sobhy Saad |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Control group | Active Comparator | This group will receive the standard care for diabetic patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Magnesium Supplementation | Dietary Supplement | 250 mg of elemental magnesium daily for three months |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Patients on insulin.
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| Name | Affiliation | Role |
|---|---|---|
| Nagwa E Saad, Professor | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mokattam primary health care unit | Cairo | Mokattam | 11562 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30815575 | Background | 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. | |
| 31250127 | 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. |
| Label | URL |
|---|---|
| Estimation of magnesium level in type 2 diabetes mellitus and its correlation with HbA1c level | View source |
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The study data will be available upon reasonable request from central contact person
After finalizing the study
The study data will be available upon reasonable request from central contact person
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| UNKNOWN |
The study participants will be randomized into 2 groups (intervention and control group) to be studied simultaneously
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| Standard Care for diabetic patients | Other | Health education, oral antihyperglycemic medications according to American Diabetes Association (ADA) guidelines |
|
| 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 |
| Epigenetics and Type 2 Diabetes Risk | View source |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |