Effect of Magnesium Supplementation on Patients With Diabetic Nephropathy

August 18, 2014 updated by: Leila Azadbakht, Isfahan University of Medical Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Magnesium Oxide
magnesium tablets, 250 milligram magnesium, 12 weeks, every day 1 tablet
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.
Other Names:
  • 21 Century company
Placebo Comparator: Placebo
Placebo tablets, the same in color, odor and appearance with magnesium tablets, 12 weeks, one tablet every day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum creatinine
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Ahmad Sadeghian, Professor, Isfahan University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

August 1, 2014

Study Completion (Anticipated)

October 1, 2014

Study Registration Dates

First Submitted

August 18, 2014

First Submitted That Met QC Criteria

August 18, 2014

First Posted (Estimate)

August 19, 2014

Study Record Updates

Last Update Posted (Estimate)

August 19, 2014

Last Update Submitted That Met QC Criteria

August 18, 2014

Last Verified

August 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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