The aim of this study is to determine the effects of N-acetylcysteine administration on metabolic profiles and serum adiponectin levels in patients with metabolic syndrome.
Design
Randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive N-acetylcysteine (n=38) or placebo (n=38).
Settings and conduct
Among patients with metabolic syndrome referred to the Endocrinology Clinic at Baqiyatallah Hospital affiliated to Baqiyatallah Medical Sciences University, Tehran, Iran, 78 patients will be selected. The study will be double blind in which participants and investigators/the assessors of the outcomes are unaware of the study groups and drug and placebo are similar. Fasting blood samples will be taken at baseline and end of the intervention. Intervention period: 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with metabolic syndrome; aged 25 to 75 years. Non-inclusion criteria: Patients with infectious, malignant and inflammatory diseases; those taking any antioxidant and/or anti-inflammatory supplements within 3 months prior to enrollment in the study; hypersensitivity to the study medication; pregnancy or breastfeeding.
Intervention groups
Intervention group: N-acetylcysteine 600 mg Tablet (Osve Pharmaceutical Co., Tehran, Iran), orally, three times a day, for 12 weeks. Control group: Placebo Tablet (Osve Pharmaceutical Co., Tehran, Iran), three times a day, orally, for 12 weeks.
Main outcome variables
Insulin resistance (primary outcome) and lipid profiles, oxidative damage biomarkers, hs-CRP, and serum adiponectin levels (secondary outcomes)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170513033941N72
Registration date:2020-06-23, 1399/04/03
Registration timing:prospective
Last update:2020-06-23, 1399/04/03
Update count:2
Registration date
2020-06-23, 1399/04/03
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-28, 1399/04/08
Expected recruitment end date
2020-08-05, 1399/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of N-acetylcysteine and placebo on metabolic profiles and serum adiponectin levels in patients with metabolic syndrome
Public title
N-acetylcysteine administration in treatment of metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with metabolic syndrome
Individuals aged 25-75 years old
Exclusion criteria:
Patients with infectious, malignant and inflammatory diseases
Those taking any antioxidant and/or anti-inflammatory supplements within 3 months prior to enrollment in the study
Hypersensitivity to the study medication
Pregnancy or breastfeeding
Age
From 25 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 76 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients will be randomly assigned into each intervention group by their numbers. The block randomization technique with 1:1 ratio will be used to achieve balanced group sizes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Endocrinology Clinic of Baqiyatallah Hospital, who is not involved in the trial and not aware of random sequences, will assign the participants to the numbered bottles of drugs. Drugs and placebos are in the same packaging at the Osve pharmaceutical company. Only the code is written on the packages. Patients and researcher will not know the type of intervention. After analyzing the data, pocket codes will be decoded. Participants and investigators/the assessors of the outcomes are unaware of the study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Baqiyatallah Medical Sciences University
Street address
Baqiyatallah Medical Sciences University, Molla Sadra Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2020-06-08, 1399/03/19
Ethics committee reference number
IR.BMSU.REC.1399.188
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
Insulin resistance
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Calculation using the Homeostasis Model Assessment (HOMA) formula
Secondary outcomes
1
Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
ELISA kit
2
Description
Fasting plasma glucose
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
5
Description
High-density lipoprotein (HDL)
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
6
Description
Low-density lipoprotein (LDL)
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
7
Description
High-sensitivity C-reactive Protein (hs-CRP)
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
ELISA kit
8
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
9
Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
10
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
11
Description
Adiponectin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
ELISA kit
Intervention groups
1
Description
Intervention group: N-acetylcysteine 600 mg Tablet (Osve Pharmaceutical Co., Tehran, Iran), orally, three times a day, for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group: Placebo Tablet (Osve Pharmaceutical Co., Tehran, Iran), three times a day, orally, for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology Clinic of Baqiyatallah Hospital
Full name of responsible person
Dr. Yunes Panahi
Street address
Baqiyatallah Medical Sciences University, Molla Sadra Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
yunespanahi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr. Gholamhosein Alishiri
Street address
Baqiyatallah Medical Sciences University, Molla Sadra Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
Alishiri.gh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr. Vahidreza Ostadmohammadi
Position
Academic Researcher
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Baqiyatallah University of Medical Sciences, Molla Sadra Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Fax
Email
vrom.1993@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr. Yunes Panahi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Baqiyatallah University of Medical Sciences, Molla Sadra Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Fax
Email
yunespanahi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr. Vahidreza Ostadmohammadi
Position
Academic Researcher
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Baqiyatallah University of Medical Sciences, Molla Sadra Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
vrom.1993@gmail.com
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