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Effect of Magnesium Supplementation on Patients With Diabetic Nephropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02220036
Recruitment Status : Unknown
Verified August 2014 by Leila Azadbakht, Isfahan University of Medical Sciences.
Recruitment status was:  Not yet recruiting
First Posted : August 19, 2014
Last Update Posted : August 19, 2014
Sponsor:
Information provided by (Responsible Party):
Leila Azadbakht, Isfahan University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Diabetes Dietary Supplement: Magnesium Oxide Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Magnesium Supplementation on Kidney Function, Insulin Resistance and Metabolic Profile in Patients With Diabetic Nephropathy
Study Start Date : June 2014
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Magnesium Oxide
magnesium tablets, 250 milligram magnesium, 12 weeks, every day 1 tablet
Dietary Supplement: Magnesium 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.
Other Name: 21 Century company

Placebo Comparator: Placebo
Placebo tablets, the same in color, odor and appearance with magnesium tablets, 12 weeks, one tablet every day



Primary Outcome Measures :
  1. Serum creatinine [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Blood Urine Nitrogen [ Time Frame: 12 weeks ]
  2. Glomerular Filtration Rate [ Time Frame: 12 weeks ]
  3. Proteinuria [ Time Frame: 12 weeks ]
  4. Fasting Blood Sugar [ Time Frame: 12 weeks ]
  5. Hemoglobin A1c [ Time Frame: 12 weeks ]
  6. Serum insulin level [ Time Frame: 12 weeks ]
  7. High Density Lipoprotein [ Time Frame: 12 weeks ]
  8. Low Density Lipoprotein [ Time Frame: 12 weeks ]
  9. Very Low Density Lipoprotein [ Time Frame: 12 weeks ]
  10. Triglyceride [ Time Frame: 12 weeks ]
  11. Total Cholesterol [ Time Frame: 12 weeks ]
  12. high sensitive C-Reactive Protein [ Time Frame: 12 week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   9 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220036


Contacts
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Contact: Ahmad Esmaeilzadeh, Professor 3117922776 ext 0098 esmaillzadeh@hlth.mui.ac.ir
Contact: Mehdi Sadeghian, Bachelor 9131017626 ext 0098 vipmaster1369@gmail.com

Locations
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Iran, Islamic Republic of
Isfahan University of Medical Sciences
Isfahan, Iran, Islamic Republic of
Contact: Ahmad Esmaeizadeh, Professor    3117922776 ext 0098    esmaillzadeh@hlth.mui.ac.ir   
Principal Investigator: Ahmad Esmaeilzadeh, professor         
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
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Study Chair: Ahmad Sadeghian, Professor Isfahan University of Medical Sciences
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Responsible Party: Leila Azadbakht, Effect of Magnesium Supplementation on Kidney Function, Insulin Resistance and Metabolic Profile in Patients With Diabetic Nephropathy, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02220036    
Other Study ID Numbers: 198476
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: August 19, 2014
Last Verified: August 2014
Keywords provided by Leila Azadbakht, Isfahan University of Medical Sciences:
Diabetic nephropathy
Renal function
Insulin resistance
Metabolic profile
Serum magnesium level
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Magnesium Oxide
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents