Protocol summary
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Study aim
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Determining of the effects of rutin on brain white matter neural tracts volume in type 2 diabetes patients by magnetic resonance imaging (MRI)
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Design
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Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 26 patients. For randomization, block design is used.
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Settings and conduct
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Referred to the endocrine clinic of Golestan Hospital of Ahvaz in 2020, selection of 26 people based on inclusion criteria, randomization into intervention and control groups, referral to Auxin imaging center in Ahvaz for MRI of the brain by diffusion tensor imaging (DTI) method. Blinding of patients and researchers, coding by a third party who does not know the details.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Willingness to participate in the study, 20 to 60 years old in both sexes, over at least 2 years from time of diagnosis of diabetes, body mass index (BMI) less than 35, glycosylated hemoglobin (HbA1c) between 6.5 to 11%
ٍExclusion criteria: Renal failure, taking insulin, thyroid disease, anemia, pregnancy, lactation, smokers, use of compounds that interfere with the effects of the supplement, following of special diets other than the diet specific to diabetic patients, history of brain surgery and brain tumors.
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Intervention groups
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The intervention group: one rutin tablet of 1g/day (made by Solgar company, USA, containing 500 mg of pure rutin and 500 mg dicalcium phosphate, microcrystalline cellulose, plant cellulose, stearic acid, stearic magnesium, silica, glycerin) for 90 days. The control group: one placebo tablet of 1g/day (compounds similar to supplement except for rutin) for 90 days.
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Main outcome variables
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Diffusion parameters such as fractional anisotropy (FA), mean diffusivity (MD), radial diffusion (RD), axial diffusivity, white matter volume of throwing, radial and communication fibers of the brain, and gray matter volume of brain
General information
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Reason for update
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High prevalence of Covid 19 disease and the lack of sampling
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20151128025274N6
Registration date:
2021-01-10, 1399/10/21
Registration timing:
prospective
Last update:
2021-08-20, 1400/05/29
Update count:
2
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Registration date
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2021-01-10, 1399/10/21
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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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2021-01-20, 1399/11/01
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Expected recruitment end date
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2021-10-23, 1400/08/01
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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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The effects of rutin flavonoid supplement on brain white matter neural tracts volume in type 2 diabetes mellitus patients by MRI
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Public title
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The effects of rutin supplement on the brain of type 2 diabetes mellitus patients
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Willingness to participate in the study
People between 20 to 60 years old in both sexes,
Over at least 2 years from time of diagnosis of type 2 diabetes mellitus
Body mass index (BMI) less than 35 (BMI ≤ 35)
Glycosylated hemoglobin (HbA1c) between 6.5 to 11%
Exclusion criteria:
Developing complications from diabetes such as renal failure
Diabetic patients taking insulin
Thyroid disease
Anemia
Pregnancy, lactation
Smokers
Use of other dietary supplements, probiotics and anti-inflammatory drugs
Use of any antioxidant supplements in the last 3 months
Use of immunosuppressive drugs
Following of special diets other than the diet specific to diabetic patients,
History of brain surgery and brain tumors.
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Age
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From 20 years old to 60 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Care provider
- Investigator
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Sample size
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Target sample size:
26
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Assignment of patients in each of the study groups (supplement or placebo) will be done by "Random allocation software" using classified randomized blocking method (block size: 4). In addition, in order to reduce selection bias error, allocation concealment will be used. This will be done by assigning unit codes (two codes A and B) to each patient's tablets. In this way, 26 patients will be randomly allocated to placebo (n = 13) or intervention (n = 13) groups. In fact, each patient will receive a can containing code A or B, and eventually 13 patients will receive cans containing code A and 13 patients will receive cans containing code B.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In the present study, the doctor, researcher, and patients will be blinded to the study groups. Before starting the study, the cans containing the respective tablets will be coded by a person other than the researcher (this person will not aware of the details of the research) to A and B, so that the type of received tablets in each group will be blinded for researcher. Also, placebo and supplement tablets will be similar in terms of color, shape, size and taste. In addition, cans containing the supplement and placebo will be quite similar.
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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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2020-12-26, 1399/10/06
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Ethics committee reference number
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IR.AJUMS.REC.1399.777
Health conditions studied
1
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Description of health condition studied
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Type 2 diabetes mellitus
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ICD-10 code
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E11
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ICD-10 code description
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Type 2 diabetes mellitus
Primary outcomes
1
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Description
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Fractional anisotropy (FA)
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Timepoint
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Before and after the intervention
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Method of measurement
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Using Diffusion Tensor Imaging (DTI) and analysis with functional magnetic resonance imaging of the brain software library (FSL) software
2
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Description
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MD: Mean diffusivity
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Timepoint
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Before and after the intervention
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Method of measurement
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Using Diffusion Tensor Imaging (DTI) and analysis with functional magnetic resonance imaging of the brain software library (FSL) software
3
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Description
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RD: Radial diffusivity
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Timepoint
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Before and after the intervention
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Method of measurement
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Using Diffusion Tensor Imaging (DTI) and analysis with functional magnetic resonance imaging of the brain software library (FSL) software
4
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Description
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AD: Axial diffusivity
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Timepoint
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Before and after the intervention
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Method of measurement
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Using Diffusion Tensor Imaging (DTI) and analysis with functional magnetic resonance imaging of the brain software library (FSL) software
5
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Description
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The volume of white matter of the throwing, radial and communication fibers of the brain
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Timepoint
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Before and after the intervention
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Method of measurement
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Using Diffusion Tensor Imaging (DTI) and analysis with functional magnetic resonance imaging of the brain software library (FSL) software
6
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Description
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The volume of gray matter of the brain
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Timepoint
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Before and after the intervention
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Method of measurement
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Using Diffusion Tensor Imaging (DTI) and analysis with functional magnetic resonance imaging of the brain software library (FSL) software
Intervention groups
1
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Description
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Intervention group: Every day, one tablet of 1 g rutin (containing 500 mg of pure rutin and 500 mg other compounds include di-calcium phosphate, microcrystalline cellulose, plant cellulose, stearic acid, magnesium stearic, silica, glycerin), made by the Solgar company, USA, after meals for 90 days.
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Category
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Treatment - Other
2
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Description
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Control group: One tablet of 1 g placebo/day (containing compound similar to supplement except rutin), made by the Faculty of Pharmacy of Ahvaz Jundishapur University of Medical Sciences, in terms of shape, color, size similar to supplement, after meals for 90 days.
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Category
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Placebo
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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Ahvaz 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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The person's information will be confidential and the results will be as collective statistics
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is 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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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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This clinical trial will be an research article and its protocol, results report and statistical analysis will be published to be used by therapists and researchers.
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When the data will become available and for how long
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If the journal has requested access to the data at any time, the data will be provided.
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To whom data/document is available
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Journal editors and Reviewers
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Under which criteria data/document could be used
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Sometimes for re-analysis or for use in meta-analysis studies
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From where data/document is obtainable
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Project manager
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What processes are involved for a request to access data/document
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Mail to ahmaddjavid@gmail.com
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Comments
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