Protocol summary
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Study aim
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Determining the effect of Crocin supplementation on glycemic indexes, oxidative stress factors and inflammation biomarkers in patients with type 2 diabetes treated by metformin
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Design
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The study was a double-blind, randomized clinical trial. Patients are divided into two groups: 1- Group of patients are prescribed metformin with a Crocin. 2. Group of patients are prescribed metformin with a placebo
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Settings and conduct
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Patients with type 2 diabetes referring to the Endocrine and Metabolism Research Center of Isfahan will be invited to participate. After assessing the entrance criteria, 10 cc blood samples are taken. Supplements are given to patients for a month.
The biochemical parameters are measured in two groups of treatment and control before and 12 weeks after treatment.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Aged 35-75 years old, type 2 diabetic patients treated by metformin. Exclusion criteria: patients with type 1 diabetes; pregnancy or lactation; taking any anti diabetic drug other than metformin; patients with other endocrine, liver, kidney, inflammatory and pulmonary disorders; take any other antioxidant supplement.
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Intervention groups
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In this study, patients with type 2 diabetes treated with metformin are divided into two groups. Intervention group: Crocin tablet; Control group: placebo tablet.
Patients in the Crocin group will receive 15 mg crocin supplement twice a day, and the control group will receive 2 tablets of placebo containing starch per day for 12 weeks. The steps of determining the dose of the patient's anti diabetic drug and the treatment process are performed under the supervision of the treating physician.
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Main outcome variables
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Glycemic indexes and lipid profiles; biomarkers of inflammation and oxidative stress factors
General information
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Reason for update
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The updating process was done to correct the registration information.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170611034458N2
Registration date:
2022-02-11, 1400/11/22
Registration timing:
registered_while_recruiting
Last update:
2024-03-27, 1403/01/08
Update count:
2
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Registration date
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2022-02-11, 1400/11/22
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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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2022-01-15, 1400/10/25
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Expected recruitment end date
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2022-08-01, 1401/05/10
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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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Exploring the effect of Crocin supplementation on glycemic indexes, oxidative stress factors and inflammation biomarkers in patients with type 2 diabetes treated by metformin
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Public title
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Effect of Crocin and Metformin in patients with type 2 diabetes
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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 2 diabetes treated by metformin
Aged 35-75 years old
Exclusion criteria:
Hypertension
Patients with other endocrine, liver, kidney, inflammatory and lung disorders
Taking metformin in combination with other anti-diabetic drugs
Take any other antioxidant supplement
Alcohol-drug abuse
Pregnant women
Patients with type 1 diabetes
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Age
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From 35 years old to 75 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
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The sixty patients with type 2 diabetes who are merely treated with metformin are selected available and easy to use. Computer-generated random numbers will be utilized for random assignment. researcher first predefined the reader for reading numbers (for example, up, down, left, or right). The second is to consider numbers for different groups (for example, pair numbers for intervention A and individual numbers for Intervention 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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This study is a double-blind (investigators and patients) trial. For double-blind implementation, at the beginning of the study, all boxes containing crocin or placebo by a third party and out of the study (someone other than the researchers) will be coded as A and B.
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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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2022-01-10, 1400/10/20
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Ethics committee reference number
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IR.MUI.RESEARCH.REC.1400.418
2
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Ethics committee
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Approval date
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2023-12-25, 1402/10/04
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Ethics committee reference number
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IR.MUI.PHANUT.REC.1402.054
3
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Ethics committee
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Approval date
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2024-01-20, 1402/10/30
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Ethics committee reference number
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IR.MUI.PHANUT.REC.1402.080
Health conditions studied
1
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Description of health condition studied
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Type 2 Diabetes
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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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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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Enzymatic assay kit
2
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Description
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Serum concentrations of insulin
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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ELISA kit
3
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Description
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Hemoglobin A1C levels
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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Enzymatic assay kit
4
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Description
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HOMA-IR
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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Using available formulas
Secondary outcomes
1
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Description
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Serum concentrations of triglyceride
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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Enzymatic assay kit
2
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Description
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HDL-C cholesterol
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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Enzymatic assay kit
3
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Description
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Total cholesterol
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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Enzymatic assay kit
4
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Description
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LDL cholesterol
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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Enzymatic assay kit
5
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Description
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Serum concentration of Total antioxidant capacity (TAC)
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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Spectrophotometry
6
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Description
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Serum concentrations of high sensitivity c-reactive protein (hs-CRP)
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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ELISA kit
7
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Description
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Malondialdehyde
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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Spectrophotometry
8
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Description
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Glutathione
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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Spectrophotometry
9
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Description
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Superoxide dismutase (SOD ) activity
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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ELISA kit
10
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Description
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Catalase activity
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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ELISA kit
11
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Description
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Protein Carbonyl Concentration
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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Spectrophotometry
12
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Description
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Advanced glycosylation end-products
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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Fluorometric method
13
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Description
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Nitric oxide
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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Spectrophotometry
14
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Description
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Expressed levels of Nrf-2 gene
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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Real-time PCR
15
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Description
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Expressed levels of NF-kB gene
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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Real-time PCR
16
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Description
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Expressed levels of AMPK gene
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Timepoint
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Real-time PCR
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Method of measurement
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Initially (before the intervention) and at the end (12 weeks after the intervention)
17
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Description
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Expressed levels of GLUT-4 gene
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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Real-time PCR
18
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Description
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Expressed levels of B-act gene
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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Real-time PCR
19
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Description
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Monocyte Chemoattractant Protein (MCP-1) plasma level
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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ELISA kit
20
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Description
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Oxidized LDL (Ox-LDL) plasma level
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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ELISA kit
21
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Description
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Vascular cell adhesion molecule 1 (VCAM-1) plasma level
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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ELISA kit
22
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Description
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Intercellular Adhesion Molecule 1 (ICAM-1) plasma level
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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ELISA kit
23
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Description
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Expressed levels of TNF-a gene
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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Real-time PCR
24
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Description
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Expressed levels of IL-6 gene
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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Real-time PCR
25
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Description
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Evaluation of atherogenic indices
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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Using available formulas
26
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Description
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Serum Creatinine
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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Enzymatic assay kit
27
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Description
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Blood Urea Nitrogen
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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Enzymatic assay kit
28
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Description
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Estimated Glomerular Filtration Rate (eGFR)
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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Using available formulas
29
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Description
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Evaluation of tubular and glomerular indices including Neutrophil gelatinase associated lipocaline (NGAL) and cystatin C
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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ELISA kit
30
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Description
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Advanced oxidation protein products (AOPP) plasma level
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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ELISA kit
31
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Description
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Expressed levels of TGF-B gene
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Timepoint
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Initially (before the intervention) and at the end (12 weeks after the intervention)
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Method of measurement
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Real-time PCR
Intervention groups
1
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Description
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Intervention group: Crocin supplementation: they will receive, for 12 weeks, two tablets of Crocin (Samisaz Company) per day, each containing 15 mg of crocin.
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Category
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Treatment - Other
2
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Description
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Control group: they will receive 2 tablets of placebo containing starch (Samisaz Company) per day for 12 weeks.
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Category
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Treatment - Other
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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Esfahan 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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Undecided - It is not yet known if there will be a plan to make this available
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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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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be 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