Clinical trial NCT02220036: Effect of Magnesium Supplementation on Patients With Diabetic Nephropathy
Official title: Effect of Magnesium Supplementation on Kidney Function, Insulin Resistance and Metabolic Profile in Patients With Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Keywords: Diabetic nephropathy
Renal function
Insulin resistance
Metabolic profile
Serum magnesium level
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-08-19
Enrollment: 80
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Serum creatinine
timeFrame: 12 weeks
Secondary outcomes:
measure: Blood Urine Nitrogen
timeFrame: 12 weeks
measure: Glomerular Filtration Rate
timeFrame: 12 weeks
measure: Proteinuria
timeFrame: 12 weeks
measure: Fasting Blood Sugar
timeFrame: 12 weeks
measure: Hemoglobin A1c
timeFrame: 12 weeks
measure: Serum insulin level
timeFrame: 12 weeks
measure: High Density Lipoprotein
timeFrame: 12 weeks
measure: Low Density Lipoprotein
timeFrame: 12 weeks
measure: Very Low Density Lipoprotein
timeFrame: 12 weeks
measure: Triglyceride
timeFrame: 12 weeks
measure: Total Cholesterol
timeFrame: 12 weeks
measure: high sensitive C-Reactive Protein
timeFrame: 12 week
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Isfahan University of Medical Sciences
Study officials:
affiliation: Isfahan University of Medical Sciences
name: Ahmad Sadeghian, Professor
role: STUDY_CHAIR
References: