DiabetesNCT02220036
Effect of Magnesium Supplementation on Patients With Diabetic Nephropathy
A study testing Magnesium Oxide in people with Diabetes, run by Isfahan University of Medical Sciences at 1 site in Iran.
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). Read more about this study
- Who is it for?
- Ages 9 to 12 months
- Conditions the study is for
- Diabetes
- What is being tested?
- Magnesium Oxide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIran
- Study dates
- Jun 2014to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- changing medicine dose
- Not having adherence (using less than 75 percent of medicines)
- Cardiac Arrhythmias
Trial locations and contacts
1 site in 1 country.
Iran1 site
Isfahan University of Medical Sciences
Isfahan, Isfahan
Ahmad Esmaeizadeh, Professor, 3117922776 ext. 0098, esmaillzadeh@hlth.mui.ac.ir
Ahmad Esmaeilzadeh, professor
About this study
Official title: 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.
Read the 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).
- Conditions
- Diabetes
- Being tested
- Magnesium Oxide
- Keywords
- Diabetic nephropathy, Renal function, Insulin resistance, Metabolic profile, Serum magnesium level
- Medical subject headings
- Diabetes Mellitus, Diabetic Nephropathies, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium OxideDietary supplement
Also called 21 Century company
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 group | Role | What they receive |
|---|---|---|
| Magnesium Oxide | Active comparator | magnesium tablets, 250 milligram magnesium, 12 weeks, every day 1 tablet Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum creatinine
Measured: 12 weeks
Secondary outcomes (12)
Blood Urine Nitrogen
Measured: 12 weeks
Glomerular Filtration Rate
Measured: 12 weeks
Proteinuria
Measured: 12 weeks
Fasting Blood Sugar
Measured: 12 weeks
Hemoglobin A1c
Measured: 12 weeks
Serum insulin level
Measured: 12 weeks
High Density Lipoprotein
Measured: 12 weeks
Low Density Lipoprotein
Measured: 12 weeks
Very Low Density Lipoprotein
Measured: 12 weeks
Triglyceride
Measured: 12 weeks
Total Cholesterol
Measured: 12 weeks
high sensitive C-Reactive Protein
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leila Azadbakht, Isfahan University of Medical Sciences
- Investigators
- Ahmad Sadeghian, Professor, Study chair, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220036
- Sponsor's protocol ID
- 198476
- Status last verified
- Aug 2014
- First submitted
- 18 Aug 2014
- Last updated
- 19 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Magnesium Supplementation on Kidney Function, Insulin Resistance and Metabolic Profile in Patients With Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT02220036
- Acronym / sponsor ID
- 198476
- Conditions
- Diabetes
- Keywords
- Diabetic nephropathy, Renal function, Insulin resistance, Metabolic profile, Serum magnesium level
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 19 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium Oxide | Active comparator | Dietary Supplement: Magnesium Oxidemagnesium tablets, 250 milligram magnesium, 12 weeks, every day 1 tablet |
| Placebo | Placebo comparator | –Placebo tablets, the same in color, odor and appearance with magnesium tablets, 12 weeks, one tablet every day |
Who may qualify
- Ages
- 9 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (3 listed)
- changing medicine dose
- Not having adherence (using less than 75 percent of medicines)
- Cardiac Arrhythmias
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium OxideAlso: 21 Century companyPatients 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. | Dietary supplement | Magnesium Oxide |
Primary outcome
Serum creatinine
Time frame: 12 weeks
12 secondary outcomes
Blood Urine Nitrogen
Time frame: 12 weeks
Glomerular Filtration Rate
Time frame: 12 weeks
Proteinuria
Time frame: 12 weeks
Fasting Blood Sugar
Time frame: 12 weeks
Hemoglobin A1c
Time frame: 12 weeks
Serum insulin level
Time frame: 12 weeks
High Density Lipoprotein
Time frame: 12 weeks
Low Density Lipoprotein
Time frame: 12 weeks
Very Low Density Lipoprotein
Time frame: 12 weeks
Triglyceride
Time frame: 12 weeks
Total Cholesterol
Time frame: 12 weeks
high sensitive C-Reactive Protein
Time frame: 12 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmad Sadeghian, Professor study chair
Isfahan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium Oxide in people with Diabetes, run by Isfahan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmad Esmaeilzadeh, Professor (3117922776 ext. 0098, esmaillzadeh@hlth.mui.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum creatinine (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2014.