Viewing Study NCT03824379



Ignite Creation Date: 2024-05-06 @ 12:41 PM
Last Modification Date: 2024-10-26 @ 1:02 PM
Study NCT ID: NCT03824379
Status: COMPLETED
Last Update Posted: 2021-01-12
First Post: 2019-01-26

Brief Title: Magnesium Supplementation in Diabetic Nephropathy
Sponsor: Ain Shams University
Organization: Ain Shams University

Study Overview

Official Title: The Impact of Magnesium Supplementation on the Clinical Outcome of Patients of Diabetic Nephropathy
Status: COMPLETED
Status Verified Date: 2021-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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-AC 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 07 to 11 mmolL 14-20 mEqL or 17-24 mgdL 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 14-19 mgdL 058-078 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-AC 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None