Effect of Magnesium Supplementation on Patients With Diabetic Nephropathy

NCT02220036 | Unknown DMC

• 1 other identifier: 198476
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Keywords

Diabetic nephropathy; Renal function; Insulin resistance; Metabolic profile; Serum magnesium level

Outcome Measures

Primary Outcomes (1)

• Serum creatinine

  12 weeks

Secondary Outcomes (12)

• Blood Urine Nitrogen

  12 weeks

• Glomerular Filtration Rate

  12 weeks

• Proteinuria

  12 weeks

• Fasting Blood Sugar

  12 weeks

• Hemoglobin A1c

  12 weeks

Study Arms (2)

Magnesium Oxide

ACTIVE COMPARATOR

magnesium tablets, 250 milligram magnesium, 12 weeks, every day 1 tablet

Dietary Supplement: Magnesium Oxide

Placebo

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: 21 Century company

Magnesium Oxide

Eligibility Criteria

• Age: 9 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• changing medicine dose
• Not having adherence (using less than 75 percent of medicines)
• Cardiac Arrhythmias

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Isfahan University of Medical Sciences

Isfahan, Isfahan, Iran

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Nephropathies; Insulin Resistance

Interventions

Magnesium Oxide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds

Study Officials

• Ahmad Sadeghian, Professor

  Isfahan University of Medical Sciences

  STUDY CHAIR

Central Study Contacts

Ahmad Esmaeilzadeh, Professor

CONTACT

3117922776; esmaillzadeh@hlth.mui.ac.ir

Mehdi Sadeghian, Bachelor

CONTACT

9131017626; vipmaster1369@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Effect of Magnesium Supplementation on Kidney Function, Insulin Resistance and Metabolic Profile in Patients With Diabetic Nephropathy

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: August 19, 2014
• Study Start: June 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: October 1, 2014
• Last Updated: August 19, 2014

Record last verified: 2014-08

Locations

IR (1)