Magnesium Supplementation in Diabetic Nephropathy
Condition: Diabetic Nephropathies
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      Higher prevalence of hypomagnesaemia in diabetic patients with nephropathy was 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).

      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.
    

Detailed description: 
      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.
    

Intervention name(s): Magnesium citrate; Antidiabetic
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): magnesium citrate equivalent 20-30 mmol elemental magnesium; insulin or oral hypoglycemics
Intervention MeSH terms: Hypoglycemic Agents; Magnesium citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective randomized controlled open label study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: magnesium; diabetic nephropathy; osteocalcin