Magnesium Supplementation in Diabetic Nephropathy
Клучни зборови
Апстракт
Опис
Diabetic nephropathy is a serious kidney-related complication of type 1 diabetes and type 2 diabetes. It is also called diabetic kidney disease. Up to 40 percent of people with diabetes eventually develop kidney disease. Over time, elevated blood sugar associated with uncontrolled diabetes causes high blood pressure which in turn damages the kidneys by increasing kidney filtration pressure. Complications of diabetic nephropathy include heart and blood vessel disease (cardiovascular disease), fluid retention and hyperkalemia. Magnesium (Mg) is the fourth most abundant cation in the body and the second most important intracellular cation. It plays an essential role in biological systems as co-factor for more than 300 essential enzymatic reactions such as signal transduction, energy metabolism, vascular processes and bone metabolism. Normal serum Mg concentrations ranges from 0.7 to 1.1 mmol/L (1.4-2.0 mEq/L or 1.7-2.4 mg/dL). Outcome studies in the general population have indicated potential associations between low serum Mg levels and atherosclerosis, hypertension, diabetes, and left ventricular hypertrophy, as well as both CVD mortality and all-cause mortality. Low SMg levels (1.4-1.9 mg/dL; 0.58-0.78 mM) were independently associated with all-cause death in patients with prevalent CKD. Higher prevalence of hypomagnesaemia in diabetic patients with nephropathy compared to those without nephropathy. Serum magnesium levels were significantly inversely correlated with serum creatinine and U-A/C ratio, and positively correlated with glomerular filtration rate (GFR). Magnesium deficiency promotes hydroxyapatite formation and calcification of vascular smooth muscle cells . It is closely related to insulin resistance and metabolic syndrome. A lower Mg level is directly associated with a faster deterioration of renal function in T2DM patients. Moreover, hypomagnesemia is associated with the long-term micro- and macrovascular complications of T2DM. A dysregulation of mineral metabolism, reflected by altered levels of magnesium and FGF-23, correlates with an increased urinary albumin to creatinine ratio (UACR) in type 2 diabetic patients with CKD stages 2-4. Also, a link between hypomagnesemia and atherogenic dyslipidemia alterations exists; a significantly raised total cholesterol and LDL and non-HDL in patients with CKD are observed, suggesting a link to increased cardiovascular risk in CKD patients. Increasing magnesium levels could attenuate the cardiovascular risk derived from hyperphosphatemia, hence the CKD progression. Current literature suggests that Mg may have a protective effect on the CV system. Mg supplementation improves the insulin resistance index and beta-cell function, and decreases hemoglobin A1c levels in type 2 DM patients. In animal models of vascular calcification VC, dietary supplementation with magnesium results in marked reduction in VC and mortality, improved mineral metabolism, including lowering of PTH, as well as improvement in renal function. Hence, Magnesium supplementation using magnesium salts could be a good approach to improve the cardiovascular complications, insulin resistance index, lipid profile and kidney function in diabetic nephropathy patients.
Датуми
Последен пат проверено: | 12/31/2019 |
Прво доставено: | 01/25/2019 |
Поднесено е проценето запишување: | 01/28/2019 |
Прво објавено: | 01/30/2019 |
Последното ажурирање е доставено: | 01/05/2020 |
Последно ажурирање објавено: | 01/06/2020 |
Крај на датумот на започнување на студијата: | 05/31/2019 |
Проценет датум на примарно завршување: | 02/29/2020 |
Проценет датум на завршување на студијата: | 02/29/2020 |
Состојба или болест
Интервенција / третман
Dietary Supplement: Magnesium arm
Drug: Antidiabetic
Фаза
Групи за раце
Рака | Интервенција / третман |
---|---|
Experimental: Magnesium arm 30 patients will receive the standard therapy (anti-diabetic ) + magnesium supplement | Dietary Supplement: Magnesium arm magnesium citrate equivalent 20-30 mmol elemental magnesium |
Active Comparator: Control 30 patients will receive the standard therapy (anti-diabetic) |
Критериуми за подобност
Возраст подобни за студии | 18 Years До 18 Years |
Полови квалификувани за студии | All |
Прифаќа здрави волонтери | Да |
Критериуми | Inclusion Criteria: 1. Age ≥ 18 years. 2. Type I or II diabetic patientCKD stage 3 ( eGFR = 30 - 59 ml/min) or stage 4 ( eGFR 15-29 ml/min) 3. Proteinuria 30-300 mg/dl (microalbuminuria) 4. Low SMg levels (1.4-1.9 mg/dL; 0.58-0.78 mM) to normal (1.7-2.4 mg/dL; 0.7 -1.1 mmol/L; 1.4-2.0 mEq/L). 5. Life expectancy >12 months. 6. Women of child-bearing age should be using contraceptives as Hormonal contraceptive or Intra-uterine device. Exclusion Criteria: 1. Kidney donor recipient. 2. Current treatment with Mg supplements. 3. Any condition impairing intestinal absorption of Mg (e.g: chronic pancreatitis, short bowel syndrome) 4. Active malignancy. 5. Pregnancy or breastfeeding. 6. Cardiac Arrythmias. 7. Allergy towards the Mg supplement. 8. Participation in other interventional trials. |
Исход
Мерки на примарниот исход
1. Change of Human Serum Osteocalcin level [Change from baseline Human Serum Osteocalcin level at 12 weeks]
Секундарни мерки на исходот
1. Serum Insulin [Samples will be measured at baseline and after 12 weeks]
2. The homeostasis model assessment-estimated insulin resistance (HOMA-IR) [Assessed at baseline and after 12 weeks]
3. Hemoglobin A1c level [Samples will be measured at baseline and after 12 weeks]
4. Fasting and Post Prandial Blood Sugar level [Samples will be measured at baseline and after 12 weeks]
5. Serum creatinine [Samples will be measured at baseline and after 12 weeks]
6. Blood Urea Nitrogen Concentration [Samples will be measured at baseline and after 12 weeks]
7. eGFR using the MDRD equation [Samples will be measured at baseline and after 12 weeks]
8. Serum Magnesium [Samples will be measured at baseline, 6 weeks and 12 weeks]
9. Evaluation of Lipid profile [Samples will be measured at baseline and after 12 weeks]
10. Fatigue Assessment [Assessed at baseline and after 12 weeks]
11. Quality of Life (QoL) Assessment: D-39 Questionnaire [Assessed at baseline and after 12 weeks]