Effects of Oral Magnesium Supplementation on Patients With Type 2 Diabetes
- Conditions
- Type2 Diabetes
- Interventions
- Dietary Supplement: Oral Magnesium SupplementationOther: Standard Care for diabetic patients
- Registration Number
- NCT04636411
- Lead Sponsor
- Samar Fares, MD
- 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. 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)
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- Patients with type 2 diabetes with HbA1C between 7 and 8%.
- Both genders will be included in this study.
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Standard Care for diabetic patients This group group will receive oral magnesium supplementation (250 mg of elemental magnesium daily for three months) plus the standard care for diabetic patients Intervention group Oral Magnesium Supplementation 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 Standard Care for diabetic patients This group will receive the standard care for diabetic patients
- Primary Outcome Measures
Name Time Method Inflammation 3 months To determine the effect of oral Mg supplementation for diabetic patient on inflammation (CRP)
Glycemic control 3 months To determine the effect of oral Mg supplementation for diabetic patient on Glycemic control
- Secondary Outcome Measures
Name Time Method Total or ionized Mg 3 months Determine the more accurate measure for Mg in diabetic patient either total or ionized Mg
Serum magnesium level 3 months To determine the effect of Mg supplementation for diabetic patient on serum Mg level
Prevalence of hypomagnesemia up to 4 weeks To estimate prevalence of hypomagnesemia in patients with type 2 DM.
Correlation of serum Mg level up to 4 weeks To assess the correlation between serum Mg level and glycemic control and level of inflammatory mediators (CRP).
Trial Locations
- Locations (1)
Mokattam primary health care unit
🇪🇬Cairo, Mokattam, Egypt