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
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium Oxide | Active Comparator | magnesium tablets, 250 milligram magnesium, 12 weeks, every day 1 tablet |
|
| Placebo | Placebo Comparator | Placebo tablets, the same in color, odor and appearance with magnesium tablets, 12 weeks, one tablet every day |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Oxide | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum creatinine | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Urine Nitrogen | 12 weeks | |
| Glomerular Filtration Rate | 12 weeks | |
| Proteinuria |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmad Esmaeilzadeh, Professor | Contact | 3117922776 | 0098 | esmaillzadeh@hlth.mui.ac.ir |
| Mehdi Sadeghian, Bachelor | Contact | 9131017626 | 0098 | vipmaster1369@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmad Sadeghian, Professor | Isfahan University of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Isfahan University of Medical Sciences | Isfahan | Isfahan | Iran |
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003928 | Diabetic Nephropathies |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008277 | Magnesium Oxide |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 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 |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D006946 | Hyperinsulinism |