Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium arm | Experimental | 30 patients will receive the standard therapy (anti-diabetic ) + magnesium supplement |
|
| Control | Active Comparator | 30 patients will receive the standard therapy (anti-diabetic) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium citrate | Dietary Supplement | magnesium citrate equivalent 20-30 mmol elemental magnesium |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Human Serum Osteocalcin level | Evaluation of the extent of cardiovadcular events | Change from baseline Human Serum Osteocalcin level at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Insulin | Evaluation of Glycemic Status | Samples will be measured at baseline and after 12 weeks |
| The homeostasis model assessment-estimated insulin resistance (HOMA-IR) | (HOMA-IR), developed by Matthews et al. will be used to assess insulin resistance. The following formula will be used in its calculation: HOMA IR = (fasting glucose mg/dl × fasting insulin μU/ml)/22.5 × 18. A normal value was considered to be <2.5 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nihal Halawa | Faculty of Pharmacy - Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Hospitals | Cairo | Abbasseia | 12345 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38107482 | Derived | Halawa N, Elsaid TW, El Wakeel LM, Shawki MA. Impact of magnesium supplementation on clinical outcome and disease progression of patients with diabetic nephropathy: a prospective randomized trial. Ther Adv Chronic Dis. 2023 Dec 12;14:20406223231214641. doi: 10.1177/20406223231214641. eCollection 2023. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| C110422 | magnesium citrate |
| D007004 | Hypoglycemic Agents |
| ID | Term |
|---|---|
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
Not provided
Not provided
prospective randomized controlled open label study
Not provided
Not provided
Not provided
Not provided
| Antidiabetic | Drug | insulin or oral hypoglycemics |
|
| Assessed at baseline and after 12 weeks |
| Hemoglobin A1c level | Evaluation of Glycemic Status | Samples will be measured at baseline and after 12 weeks |
| Fasting and Post Prandial Blood Sugar level | Evaluation of Glycemic Status | Samples will be measured at baseline and after 12 weeks |
| Serum creatinine | Evaluation of kidney function | Samples will be measured at baseline and after 12 weeks |
| Blood Urea Nitrogen Concentration | Evaluation of kidney function | Samples will be measured at baseline and after 12 weeks |
| eGFR using the MDRD equation | Evaluation of kidney function. GFR (mL/min/1.73 m2) = 175 × (Scr)-1.154 × (Age)-0.203 × (0.742 if female) × (1.212 if African American) | Samples will be measured at baseline and after 12 weeks |
| Serum Magnesium | Evaluation of SMg level | Samples will be measured at baseline, 6 weeks and 12 weeks |
| Evaluation of Lipid profile | Serum Low-density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Triglycerides | Samples will be measured at baseline and after 12 weeks |
| Fatigue Assessment | Fatigue Assessment using Fatigue Severity Scale (FSS). It is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in a variety of disorders. > 4 points indicates no fatigue 4 points or more indicates increasing fatigue | Assessed at baseline and after 12 weeks |
| Quality of Life (QoL) Assessment: D-39 Questionnaire | Quality of Life (QoL) assessment using D-39 Questionnaire | Assessed at baseline and after 12 weeks |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |