Effect of Magnesium Supplementation on Patients With Diabetic Nephropathy

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02220036
• Other study ID #: 198476
• Status: Not yet recruiting
• Phase: N/A
• First received: August 18, 2014
• Last updated: August 18, 2014
• Start date: June 2014
• Est. completion date: October 2014

Study information

• Verified date: August 2014
• Source: Isfahan University of Medical Sciences
• Contact: Ahmad Esmaeilzadeh, Professor
• Phone: 3117922776
• Email: esmaillzadeh[@]hlth.mui.ac.ir
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: October 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Months to 12 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetic Nephropathies
• Insulin Resistance
• Kidney Diseases

Intervention

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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Isfahan University of Medical Sciences	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum creatinine		12 weeks	Yes
Secondary	Blood Urine Nitrogen		12 weeks	Yes
Secondary	Glomerular Filtration Rate		12 weeks	Yes
Secondary	Proteinuria		12 weeks	Yes
Secondary	Fasting Blood Sugar		12 weeks	Yes
Secondary	Hemoglobin A1c		12 weeks	Yes
Secondary	Serum insulin level		12 weeks	Yes
Secondary	High Density Lipoprotein		12 weeks	Yes
Secondary	Low Density Lipoprotein		12 weeks	Yes
Secondary	Very Low Density Lipoprotein		12 weeks	Yes
Secondary	Triglyceride		12 weeks	Yes
Secondary	Total Cholesterol		12 weeks	Yes
Secondary	high sensitive C-Reactive Protein		12 week	Yes