Protocol summary

Study aim
To assess the effect of Nano-curcumin on insulin resistance and serum levels of Afamin in patients with metabolic syndrome
Design
This is a before-after clinical trial, in which 60 eligible patients will be assigned to the intervention and control groups
Settings and conduct
The eligible patients with metabolic syndrome who will refer to Shahid Beheshti Hospital in Hamadan City during the study period will be enrolled in the trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 18 to 65 years Metabolic syndrome Exclusion criteria: Diabetes Thyroid disease Liver disease Renal disease
Intervention groups
Intervention group: Tablet Nano-curcumin 80 mg/day for 2 months Control group: In comparison with before intervention
Main outcome variables
Primary outcome: Measuring the serum levels Measuring the serum levels

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120215009014N277
Registration date: 2019-05-13, 1398/02/23
Registration timing: registered_while_recruiting

Last update: 2019-05-13, 1398/02/23
Update count: 0
Registration date
2019-05-13, 1398/02/23
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-06, 1397/12/15
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Nano-curcumin on insulin resistance and serum levels of Afamin in patients with metabolic syndrome: a before-after clinical trial
Public title
Effect of Nano-curcumin on insulin resistance and serum levels of Afamin in patients with metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years Metabolic syndrome
Exclusion criteria:
Diabetes Thyroid disease Liver disease Renal disease
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2019-02-23, 1397/12/04
Ethics committee reference number
IR.UMSHA.REC.1397.873

Health conditions studied

1

Description of health condition studied
Metabolic syndrome
ICD-10 code
E88.81
ICD-10 code description
Metabolic syndrome

Primary outcomes

1

Description
Measuring the serum levels of Afamin
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
Through laboratory test

2

Description
Measuring the serum levels of insulin
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
Through laboratory test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Tablet Nano-curcumin 80 mg/day for 2 months
Category
Treatment - Drugs

2

Description
Control group: In comparison with before intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital in Hamadan Cit
Full name of responsible person
Zahra Khodamoradi
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0283
Email
khodamoradizahra@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Zahra Khodamoradi
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
khodamoradizahra@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Akram Ranjbar
Position
Toxicologist
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
akranjbar2015@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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