Protocol summary
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Study aim
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Determination of the effects of rutin flavonoid supplement on glycemic status, lipid profile, plasma atherogenic index, brain derived neurotropic factor (BDNF), some serum inflammatory biomarkers and oxidative stress in patients with type 2 diabetes mellitus
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Design
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Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 50 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 50 patients based on inclusion and exclusion criteria, randomization into intervention and control groups. 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, age between 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% Non-inclusion criteria: Kidney 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, change of diet or decide to lose weight
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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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Fasting blood glucose, HbA1C, insulin resistance and insulin sensitivity indices, lipid profile, plasma atherogenic index and serum levels of IL-6, TAC, MDA, BDNF and Insulin
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:
IRCT20151128025274N5
Registration date:
2020-12-30, 1399/10/10
Registration timing:
prospective
Last update:
2021-08-21, 1400/05/30
Update count:
2
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Registration date
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2020-12-30, 1399/10/10
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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 glycemic status, lipid profile, plasma atherogenic index, brain derived neurotropic factor (BDNF), some serum inflammatory biomarkers and oxidative stress in patients with type 2 diabetes mellitus
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Public title
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The effects of rutin flavonoid on type 2 diabetes mellitus
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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:
Reluctance of patients to participate in the study
Developing complications from diabetes such as kidney failure
Diabetic patients taking insulin
Thyroid disease
Anemia
Pregnancy, lactation
Traveling more than 2 weeks
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
Change of diet or decide to lose weight
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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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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Based on inclusion criteria, 50 patients will randomly allocated to placebo (n = 25) or intervention (n = 25) groups. Block design based on the combined analysis and using packed envelopes is used for randomization. In fact, according to pattern and using two codes of A and B 6 groups with 4 blocks are selected. This work is repeated in 2 steps. At the end, two A and B codes are assigned to the 2 last patients and the randomization is completed (50 patients). (step1; AABB, BBAA, ABAB, BABA, ABBA, BABA, step2; AABB, BBAA, ABAB, BABA, ABBA, BABA and AB).
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The researchers and patients will not informed of the contents of the packets. A third person of health care does the coding. This person will not
aware of the details of the research trial.
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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.1399.758
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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Fasting blood sugar
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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 enzymatic kit method
Secondary outcomes
1
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Description
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Insulin
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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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ELISA
2
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Description
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HbA1C
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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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By HPLC method and with Ds5 device
3
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Description
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HOMA -IR
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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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[FPG (mmol / l x FPI (FIU/ml)] / 22.5
4
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Description
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QUICKi
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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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1 / [log (I0) + log (G0)] ISQUICKi
5
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Description
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Plasma atherogenic index
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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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log TG/HDL
6
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Description
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HDL-c
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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 enzymatic kit method
7
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Description
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Triglyceride
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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 enzymatic kit method
8
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Description
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LDL.C
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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 enzymatic kit method
9
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Description
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Total cholestrol
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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 enzymatic kit method
10
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Description
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IL-6
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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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ELISA
11
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Description
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TAC
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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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ELISA
12
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Description
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MDA
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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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ELISA
13
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Description
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BDNF
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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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ELISA
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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Undecided - It is not yet known if there will be 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 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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It should be send email to project manager and after reviewing the reason for requesting the data, they will be send
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Comments
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