Examining the effect of Curcumin on fasting blood sugar and insulin resistance index in prediabetic individuals
Design
Triple-blind parallel randomized clinical trial with control group, phase 2-3 on 56 patients. We will use the website (www.sealedenvelope.com) for randomization.
Settings and conduct
Prediabetic individuals with mentioned inclusion criteria that refer to endocrinology clinic of university hospitals or private clinics in Mashhad, will be enrolled to this study after informed consent. They will be divided into two groups of intervention (curcumin) and control (placebo). The study period is 3 months. Fasting Blood Sugar (FBS), HOMA-IR, HbA1C, insulin, and CRP will be assessed and compared between two groups at baseline and after 3 months.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Individuals aged 18-70 years with prediabetes status, Satisfaction for participation in research project.
Exclusion Criteria: Using anti diabetic drugs or other drugs which affect on blood sugar such as Thiazide, Glucocorticoids, and Anti-psychotics; Systemic disorders such as hepatic or renal failure; Oral intolerance; Using anti-coagulant drugs.
Intervention groups
Intervention group: Curcumin tablet daily (contains 500 mg Curcumin and 5 mg Piperine).
Control group: placebo (similar to intervention in shape, size and color)
Main outcome variables
FBS (Fasting Blood Sugar), HOMA-IR, HbA1C, insulin, CRP at baseline and after 3 months
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181022041407N2
Registration date:2023-01-28, 1401/11/08
Registration timing:prospective
Last update:2023-01-28, 1401/11/08
Update count:0
Registration date
2023-01-28, 1401/11/08
Registrant information
Name
Maryam Emadzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9262
Email address
emadzadehm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Examining the effect of Curcumin on fasting blood sugar and insulin resistance index in prediabetic individuals
Public title
Investigating the effect of Curcumin on prediabetic individuals
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals aged 18-70 years
Prediabetes status
Satisfaction for participation in research project
Exclusion criteria:
Using anti diabetic drugs or other drugs which affect on blood sugar such as Thiazide, Glucocorticoids, Anti-psychotics
Systemic disorders such as hepatic or renal failure
Oral intolerance
Using anti-coagulant drugs
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization was done using the block sizes of 4 and 6 with randomization websites such as sealedenvelope.com. After randomization, the type of treatment is written with odds and even numbers (or A/B codes) in separate papers and placed in an opaque envelope or the paper will wrap so that no one can see inside the paper (random concealment). After obtaining informed consent from the participants, one paper will be taken in order and according to the noted code, the child is place in one of the intervention or placebo groups
Blinding (investigator's opinion)
Triple blinded
Blinding description
As mentioned before, after randomization, the patients place in two groups of A/B (or odds/even codes) and received the products similar in shape, color and size (blinding of participants). The physician who will give the products to participants, received the boxes of the products with randomized codes (so the physician is blind too). The information of the patients and theirs treatment groups will be written with randomized codes (A/B) (the blinding of the assessor). Data will be entered to the SPSS software with codes (the blinding of the analyzer).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine, Mashhad University of Medical Sciences
Street address
Faculty of Medicine, University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2022-12-20, 1401/09/29
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.593
Health conditions studied
1
Description of health condition studied
Prediabetes
ICD-10 code
R73.0
ICD-10 code description
Abnormal glucose tolerance test
Primary outcomes
1
Description
FBS (Fasting Blood Sugar)
Timepoint
Baseline and after 3 months.
Method of measurement
Blood sample
2
Description
HOMA-IR (Homeostatic Model Assessment for Insulin Resistance)