Protocol summary
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Study aim
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1. Comparison of effects of co-administration of atorvastatin and melatonin with atorvastatin and placebo on the ratio of urine albumin to creatinine in type-2 diabetic patients with microalbuminuria.
2. Comparison of effects of co-administration of atorvastatin and melatonin with atorvastatin and placebo on the rate of eGFR in type-2 diabetic patients with microalbuminuria.
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Design
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Randomised, parallel group trial with blinded outcome assessment. The sample size is120 patients. The random number table and block randomization method will be used for randomization.
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Settings and conduct
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Patients will be recruited from Firoozgar Hospital Endocrine Research Center.
Patients who are eligible will sign informed consent form.
Screening is done 30 days before treatment.
Laboratory tests will be performed before the start of treatment and at 6 months after treatment.
During the study, unwanted side effects will be investigated.
Blood tests include serum creatinine, triglyceride, LDL-c, HDL-c, total cholesterol, fasting blood glucose, serum BUN. Urinalysis involves taking 24-hour urine and measuring urine volume, urine creatinine, urine albumin, and the ratio of urine albumin to creatinine and the rate of GFR.
Patients, physicians, people who put medications in cans and data collection authorities will be blind.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Type II diabetic patients with microalbuminuria.
Patients who sign informed consent form.
Patients with HbA1c < 8%
Exclusion criteria:
Patients with blood pressure > 160⁄90 mmHg
Patients with statins intolerance.
Pregnant or breast-feeding patients.
Patients with a history of alcohol abuse or smoking.
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Intervention groups
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Group 1: Patients receiving atorvastatin (20 mg) and placebo.
Group 2: Patients receiving melatonin (3 mg) and atorvastatin (20 mg) simultaneously.
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Main outcome variables
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Urine albumin to creatinine ratio
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20181118041689N1
Registration date:
2018-11-24, 1397/09/03
Registration timing:
prospective
Last update:
2019-10-01, 1398/07/09
Update count:
1
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Registration date
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2018-11-24, 1397/09/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-01-21, 1398/11/01
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Expected recruitment end date
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2020-11-21, 1399/09/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluating the effect of co-administration of melatonin and atorvastatin in type II diabetic patients with microalbuminuria
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Public title
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The effect of melatonin and atorvastatin on diabetic nephropathy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with type II diabetes
Diabetic patient over 40 years of age.
Patients with microalbuminuria (urinary albumin 30- 300 mg/24h)
Patients who sign a written informed consent form.
Patients with HbA1c of < 8%
Exclusion criteria:
Patients with blood pressure > 160 ⁄ 90 mmHg
Patients with statins intolerance.
Patients with statin-inducedmyopathy
Patients who have used immunosuppressive drugs within 3 months of the first screening visit.
Patients with intolerance to blood pressure reducing drugs (e.g., angiotensin II receptor-blocking drugs)
Patients with other illness likely to influence the trial such as congestive heart failure, hypothyroidism, severe kidney failure, polycystic kidney disease, HIV nephropathy, ischemic kidney disease, interstitial nephritis of idiopathic kidney and hepatic failure
Patients who have been kidney transplant in the past.
Patients who have taken part in other clinical trials in the last 3 months.
Patients who are pregnant or breast-feeding.
Patients who are researchers and co-workers in this trial.
Patients with a history of alcohol abuse or smoking.
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Age
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From 40 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
120
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The random number table and block randomization method will be used using http://www.randomizer.org.In this method, eligible patients are divided into blocks of 4 patients. We create random numbers using computer.Based on the determined numerical range to enter individuals in each group, half of the patients in each block will receive atorvastatin (20 mg) and placebo and half of them receive atorvastatin (20 mg) and Melatonin (3 mg).
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants, the person who puts the medication in cans and labels on the cans, the person who selects and enrols the eligible patients, A person who blocks patients and determines the allocation of medications to patients, the doctor who gives the medications to the patients, data collection authorities, those who evaluate the outcome and those who prepare the draft article do not know what kind of drugs are in each can.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-11-12, 1397/08/21
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Ethics committee reference number
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IR.IUMS.REC.1397.220
Health conditions studied
1
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Description of health condition studied
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Type 2 diabetes mellitus with kidney complication
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ICD-10 code
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E11.2
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ICD-10 code description
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Type 2 diabetes mellitus with kidney complications
Primary outcomes
1
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Description
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Urine albumin to creatinine ratio
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Timepoint
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Before the start of intervention and at 6 months after the start of treatment.
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Method of measurement
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Measuring creatinine and albumin levels in urine using biochemical tests.
Secondary outcomes
1
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Description
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Glomerular filtration rate (GFR)
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Timepoint
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Before the start of intervention and at 6 months after the start of treatment.
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Method of measurement
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The measurement is based on the results of blood creatinine, urine creatinine and 24-hour urine volume.
2
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Description
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Serum creatinine
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Timepoint
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Before the start of intervention and at 6 months after the start of treatment
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Method of measurement
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Using biochemical tests
3
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Description
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Blood triglyceride level
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Timepoint
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Before the start of intervention and at 6 months after the start of treatment
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Method of measurement
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Using biochemical tests
4
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Description
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Blood level of HDL cholesterol
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Timepoint
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Before the start of intervention and at 6 months after the start of treatment
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Method of measurement
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Using biochemical tests
5
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Description
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Blood level of LDL cholesterol
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Timepoint
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Before the start of intervention and at 6 months after the start of treatment
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Method of measurement
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Using biochemical tests
6
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Description
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Blood level of total cholesterol
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Timepoint
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Before the start of intervention and at 6 months after the start of treatment
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Method of measurement
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Using biochemical tests
7
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Description
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The level of fasting blood glucose
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Timepoint
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Before the start of intervention and at 6 months after the start of treatment
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Method of measurement
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Using biochemical tests
8
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Description
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The level of Blood Urea Nitrogen (BUN)
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Timepoint
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Before the start of intervention and at 6 months after the start of treatment
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Method of measurement
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Using biochemical tests
Intervention groups
1
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Description
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Control group: Patients with type II diabetes who have microalbuminuria and receive atorvastatin (20 mg) and placebo once a day for 6 months.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: Patients with type II diabetes who have microalbuminuria and receive at the same time atorvastatin (20 mg) and Melatonin (3 mg) once a day for 6 months.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no more information.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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Informed consent form
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When the data will become available and for how long
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The start of the access period is 9 months after the publish of results.
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To whom data/document is available
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The data will only be available to researchers working in academic and scientific institutions.
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Under which criteria data/document could be used
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People do not have any right to any analysis on the delivered data.
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From where data/document is obtainable
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Iran University of Medical Sciences, Razi Drug Research Center, Dr. Hosseinzadeh
Email: Azam.hosseinzade@yahoo.com
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What processes are involved for a request to access data/document
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Apply to Vice Chancellor for Research & Technology of Iran University of Medical Sciences.
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Comments
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