Effect of Magnesium Supplementation on Patients With Diabetic Nephropathy

Study Overview
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Brief Summary
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This is a double-blind randomized clinical trial which will start at June 2014 and end on June 2015 in Isfahan city. Serum creatinine level is considered as a key variable and the sample size calculated 80 persons (40 persons for control group and 40 persons for patient group). Patients aged more than 18 years old with diabetic nephropathy having Fasting Blood Sugar more than 126 mg/dL and proteinuria 30-300 mg/dL (microalbuminuria) and Glomerular Filtration Rate more than 90 mL/min will be chosen. Patient group will receive magnesium supplement (250 milligram) and the other group will receive placebo which is similar to the magnesium tablets in color, odor and appearance both for 12 weeks. All subjects will complete 4 physical activity and 4 dietary records. Outcome measurements including metabolic, renal and inflammatory profiles will be measured at the beginning and end of the study as well as anthropometric measurements.

Detailed Description
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This is a double-blind randomized clinical trial which will start at June 2014 and end on June 2015 in Isfahan city. Serum creatinine level is considered as a key variable and the sample size calculated 80 persons (40 persons for control group and 40 persons for patient group).

Official Title
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Effect of Magnesium Supplementation on Kidney Function, Insulin Resistance and Metabolic Profile in Patients With Diabetic Nephropathy

Conditions
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Diabetes

Intervention / Treatment
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* Dietary Supplement: Magnesium Oxide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: more than 18 years old diabetic nephropathy Fasting Blood Sugar more than 126 milligram per deciliter Proteinuria 30-300 milligram per deciliter (microalbuminuria) Glomerular Filtration Rate more than 90 milliliter per minute Not having hyperthyroidism or hypothyroidism Not having any feverish urinary tract infection Not using any kind of drug including Cigarette Not having any liver disease Not having any cancer and inflammatory diseases Not having more than 4 kilogram weight loss during last 3 months Not using any magnesium-rich supplement Exclusion Criteria: changing medicine dose Not having adherence (using less than 75 percent of medicines) Cardiac Arrhythmias

Ages Eligible for Study
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Minimum Age: 9 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Magnesium Oxide<br>magnesium tablets, 250 milligram magnesium, 12 weeks, every day 1 tablet | Dietary Supplement: Magnesium Oxide<br>* Patients aged more than 18 years old with diabetic nephropathy having Fasting Blood Sugar more than 126 mg/dL and proteinuria 30-300 mg/dL (microalbuminuria) and Glomerular Filtration Rate more than 90 mL/min will be chosen. Patient group will receive magnesium supplement (250 milligram) and the other group will receive placebo which is similar to the magnesium tablets in color, odor and appearance both for 12 weeks. All subjects will complete 4 physical activity and 4 dietary records. Outcome measurements including metabolic, renal and inflammatory profiles will be measured at the beginning and end of the study as well as anthropometric measurements.<br>* Other names: 21 Century company;|
| Placebo Comparator: Placebo<br>Placebo tablets, the same in color, odor and appearance with magnesium tablets, 12 weeks, one tablet every day | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum creatinine |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Urine Nitrogen |  | 12 weeks | 
| Glomerular Filtration Rate |  | 12 weeks | 
| Proteinuria |  | 12 weeks | 
| Fasting Blood Sugar |  | 12 weeks | 
| Hemoglobin A1c |  | 12 weeks | 
| Serum insulin level |  | 12 weeks | 
| High Density Lipoprotein |  | 12 weeks | 
| Low Density Lipoprotein |  | 12 weeks | 
| Very Low Density Lipoprotein |  | 12 weeks | 
| Triglyceride |  | 12 weeks | 
| Total Cholesterol |  | 12 weeks | 
| high sensitive C-Reactive Protein |  | 12 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic nephropathy, Renal function, Insulin resistance, Metabolic profile, Serum magnesium level