Type2 Diabetes
Conditions
Keywords
Oral Magnesium, Type 2 Diabetes, Diabetes Control, HbA1c, Inflammation
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.
Interventions
DIETARY_SUPPLEMENTOral Magnesium Supplementation
250 mg of elemental magnesium daily for three months
OTHERStandard Care for diabetic patients
Health education, oral antihyperglycemic medications according to American Diabetes Association (ADA) guidelines
Sponsors
Walaa Reda Abdel Fattah Mohamed Badr
Marwa Mostafa Ahmed
Moushira Hosny Ezzelarab Sayed
Nagwa Eid Sobhy Saad
Samar Fares, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
The study participants will be randomized into 2 groups (intervention and control group) to be studied simultaneously
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic control | 3 months | To determine the effect of oral Mg supplementation for diabetic patient on Glycemic control |
| Inflammation | 3 months | To determine the effect of oral Mg supplementation for diabetic patient on inflammation (CRP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Total or ionized Mg | 3 months | Determine the more accurate measure for Mg in diabetic patient either total or ionized Mg |
Countries
Egypt
Outcome results
None listed