Diabetes
Conditions
Keywords
Diabetic nephropathy, Renal function, Insulin resistance, Metabolic profile, Serum magnesium level
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).
Interventions
DIETARY_SUPPLEMENTMagnesium Oxide
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.
Sponsors
Isfahan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
9 Months to 12 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum creatinine | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Glomerular Filtration Rate | 12 weeks |
| Proteinuria | 12 weeks |
| Fasting Blood Sugar | 12 weeks |
| Hemoglobin A1c | 12 weeks |
| Serum insulin level | 12 weeks |
| Blood Urine Nitrogen | 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 |
| High Density Lipoprotein | 12 weeks |
Countries
Iran
Contacts
Primary ContactAhmad Esmaeilzadeh, Professor
Backup ContactMehdi Sadeghian, Bachelor
Outcome results
None listed