Effect of Magnesium Supplementation on Patients With Diabetic Nephropathy
Primary Purpose
Diabetes
Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Magnesium Oxide
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes focused on measuring Diabetic nephropathy, Renal function, Insulin resistance, Metabolic profile, Serum magnesium level
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
Sites / Locations
- Isfahan University of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Magnesium Oxide
Placebo
Arm Description
magnesium tablets, 250 milligram magnesium, 12 weeks, every day 1 tablet
Placebo tablets, the same in color, odor and appearance with magnesium tablets, 12 weeks, one tablet every day
Outcomes
Primary Outcome Measures
Serum creatinine
Secondary Outcome Measures
Blood Urine Nitrogen
Glomerular Filtration Rate
Proteinuria
Fasting Blood Sugar
Hemoglobin A1c
Serum insulin level
High Density Lipoprotein
Low Density Lipoprotein
Very Low Density Lipoprotein
Triglyceride
Total Cholesterol
high sensitive C-Reactive Protein
Full Information
NCT ID
NCT02220036
First Posted
August 18, 2014
Last Updated
August 18, 2014
Sponsor
Isfahan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02220036
Brief Title
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
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes
Keywords
Diabetic nephropathy, Renal function, Insulin resistance, Metabolic profile, Serum magnesium level
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Magnesium Oxide
Arm Type
Active Comparator
Arm Description
magnesium tablets, 250 milligram magnesium, 12 weeks, every day 1 tablet
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets, the same in color, odor and appearance with magnesium tablets, 12 weeks, one tablet every day
Intervention Type
Dietary Supplement
Intervention Name(s)
Magnesium Oxide
Other Intervention Name(s)
21 Century company
Intervention Description
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.
Primary Outcome Measure Information:
Title
Serum creatinine
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Blood Urine Nitrogen
Time Frame
12 weeks
Title
Glomerular Filtration Rate
Time Frame
12 weeks
Title
Proteinuria
Time Frame
12 weeks
Title
Fasting Blood Sugar
Time Frame
12 weeks
Title
Hemoglobin A1c
Time Frame
12 weeks
Title
Serum insulin level
Time Frame
12 weeks
Title
High Density Lipoprotein
Time Frame
12 weeks
Title
Low Density Lipoprotein
Time Frame
12 weeks
Title
Very Low Density Lipoprotein
Time Frame
12 weeks
Title
Triglyceride
Time Frame
12 weeks
Title
Total Cholesterol
Time Frame
12 weeks
Title
high sensitive C-Reactive Protein
Time Frame
12 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmad Esmaeilzadeh, Professor
Phone
3117922776
Ext
0098
Email
esmaillzadeh@hlth.mui.ac.ir
First Name & Middle Initial & Last Name or Official Title & Degree
Mehdi Sadeghian, Bachelor
Phone
9131017626
Ext
0098
Email
vipmaster1369@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmad Sadeghian, Professor
Organizational Affiliation
Isfahan University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Isfahan University of Medical Sciences
City
Isfahan
Country
Iran, Islamic Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmad Esmaeizadeh, Professor
Phone
3117922776
Ext
0098
Email
esmaillzadeh@hlth.mui.ac.ir
First Name & Middle Initial & Last Name & Degree
Ahmad Esmaeilzadeh, professor
12. IPD Sharing Statement
Learn more about this trial
Effect of Magnesium Supplementation on Patients With Diabetic Nephropathy
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