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Protocol summary
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.
Among patients with metabolic syndrome referred to the Endocrinology Clinic at Baqiyatallah Hospital affiliated to Baqiyatallah Medical Sciences University, Tehran, Iran, 76 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.
Among patients with metabolic syndrome referred to the Endocrinology Clinic at Baqiyatallah Hospital affiliated to Baqiyatallah Medical Sciences University, Tehran, Iran, 7876 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.
از بین بیماران مبتلا به سندرم متابولیک ارجاع شده به کلینیک غدد بیمارستان بقیه الله وابسته به دانشگاه علوم پزشکی بقیه الله، تهران، ایران، 78 بیمار انتخاب خواهند شد. این مطالعه به صورت دوسویه کور است و هم شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروه های مطالعه بی اطلاعند. داروها و پلاسبو مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته.
از بین بیماران مبتلا به سندرم متابولیک ارجاع شده به کلینیک غدد بیمارستان بقیه الله وابسته به دانشگاه علوم پزشکی بقیه الله، تهران، ایران، 76 بیمار انتخاب خواهند شد. این مطالعه به صورت دوسویه کور است و هم شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروه های مطالعه بی اطلاعند. داروها و پلاسبو مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته.
از بین بیماران مبتلا به سندرم متابولیک ارجاع شده به کلینیک غدد بیمارستان بقیه الله وابسته به دانشگاه علوم پزشکی بقیه الله، تهران، ایران، 7876 بیمار انتخاب خواهند شد. این مطالعه به صورت دوسویه کور است و هم شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروه های مطالعه بی اطلاعند. داروها و پلاسبو مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته.
General information
2020-08-05, 1399/05/15
2021-12-24, 1400/10/03
20202021-0812-0524 00:00:00
empty
The updating process was done before publishing the paper to correct the registration information.
The updating process was done before publishing the paper to correct the registration information.
empty
پروسه بروزرسانی قبل از انتشار مقاله به منظور تصحیح اطلاعات ثبت انجام گرفت.
پروسه بروزرسانی قبل از انتشار مقاله به منظور تصحیح اطلاعات ثبت انجام گرفت.
Recruitment centers
#1
Name of recruitment center - English: Endocrinology Clinic of Baqiyatallah Hospital
Name of recruitment center - Persian: کلینیک غدد بیمارستان بقیه الله
Full name of responsible person - English: Dr. Yunes Panahi
Full name of responsible person - Persian: دکتر یونس پناهی
Street address - English: Baqiyatallah Medical Sciences University, Molla Sadra Avenue, Tehran
Street address - Persian: تهران، خیابان ملاصدرا، دانشگاه علوم پزشکی بقیه الله
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1435916471
Phone: +98 21 8804 0060
Fax:
Email: yunespanahi@yahoo.com
Web page address:
Name of recruitment center - English: Endocrinology Clinic of Baqiyatallah Hospital
Name of recruitment center - Persian: کلینیک غدد بیمارستان بقیه الله
Full name of responsible person - English: Dr. Yunes Panahi
Full name of responsible person - Persian: دکتر یونس پناهی
Street address - English: Baqiyatallah University of Medical Sciences, Molla Sadra Avenue, Tehran
Street address - Persian: تهران، خیابان ملاصدرا، دانشگاه علوم پزشکی بقیه الله
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1435916471
Phone: +98 21 8804 0060
Fax:
Email: yunespanahi@yahoo.com
Web page address:
Name of recruitment center - English: Endocrinology Clinic of Baqiyatallah Hospital Name of recruitment center - Persian: کلینیک غدد بیمارستان بقیه الله Full name of responsible person - English: Dr. Yunes Panahi Full name of responsible person - Persian: دکتر یونس پناهی Street address - English: Baqiyatallah University of Medical Sciences University, Molla Sadra Avenue, Tehran Street address - Persian: تهران، خیابان ملاصدرا، دانشگاه علوم پزشکی بقیه الله City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1435916471 Phone: +98 21 8804 0060 Fax: Email: yunespanahi@yahoo.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Gholamhosein Alishiri
Full name of responsible person - Persian: دکتر غلامحسین علیشیری
Street address - English: Baqiyatallah Medical Sciences University, Molla Sadra Avenue, Tehran
Street address - Persian: تهران، خیابان ملاصدرا، دانشگاه علوم پزشکی بقیه الله
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1435916471
Phone: +98 21 8804 0060
Fax:
Email: Alishiri.gh@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Gholamhosein Alishiri
Full name of responsible person - Persian: دکتر غلامحسین علیشیری
Street address - English: Baqiyatallah University of Medical Sciences, Molla Sadra Avenue, Tehran
Street address - Persian: تهران، خیابان ملاصدرا، دانشگاه علوم پزشکی بقیه الله
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1435916471
Phone: +98 21 8804 0060
Fax:
Email: Alishiri.gh@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Gholamhosein Alishiri Full name of responsible person - Persian: دکتر غلامحسین علیشیری Street address - English: Baqiyatallah University of Medical Sciences University, Molla Sadra Avenue, Tehran Street address - Persian: تهران، خیابان ملاصدرا، دانشگاه علوم پزشکی بقیه الله City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1435916471 Phone: +98 21 8804 0060 Fax: Email: Alishiri.gh@gmail.com Web page address:
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Vahidreza Ostadmohammadi
Full name of responsible person - Persian: دکتر وحیدرضا استادمحمدی
Position - English: Academic Researcher
Position - Persian: محقق آکادمیک
Latest degree: med_doctor
Area of specialty/work: 30
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Baqiyatallah University of Medical Sciences, Molla Sadra Avenue, Tehran
Street address - Persian: تهران، خیابان ملاصدرا، دانشگاه علوم پزشکی بقیه الله
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1435916471
Phone: +98 21 8804 0060
Mobile: +98 912 633 9401
Fax:
Email: vrom.1993@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Yunes Panahi
Full name of responsible person - Persian: دکتر یونس پناهی
Position - English: Academic Researcher
Position - Persian: محقق آکادمیک
Latest degree: specialist
Area of specialty/work: 41
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Baqiyatallah University of Medical Sciences, Molla Sadra Avenue, Tehran
Street address - Persian: تهران، خیابان ملاصدرا، دانشگاه علوم پزشکی بقیه الله
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1435916471
Phone: +98 21 8804 0060
Mobile: +98 912 327 0993
Fax:
Email: yunespanahi@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Vahidreza OstadmohammadiYunes Panahi Full name of responsible person - Persian: دکتر وحیدرضا استادمحمدییونس پناهی Position - English: Academic Researcher Position - Persian: محقق آکادمیک Latest degree: med_doctorspecialist Area of specialty/work: 3041 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Baqiyatallah University of Medical Sciences, Molla Sadra Avenue, Tehran Street address - Persian: تهران، خیابان ملاصدرا، دانشگاه علوم پزشکی بقیه الله City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1435916471 Phone: +98 21 8804 0060 Mobile: +98 912 633 9401327 0993 Fax: Email: vrom.1993yunespanahi@gmail.comyahoo.com Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Vahidreza Ostadmohammadi
Full name of responsible person - Persian: دکتر وحیدرضا استادمحمدی
Position - English: Academic Researcher
Position - Persian: محقق آکادمیک
Latest degree: med_doctor
Area of specialty/work: 30
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Baqiyatallah University of Medical Sciences, Molla Sadra Avenue, Tehran
Street address - Persian: تهران، خیابان ملاصدرا، دانشگاه علوم پزشکی بقیه الله
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1435916471
Phone: +98 21 8804 0060
Mobile: +98 912 633 9401
Fax:
Email: vrom.1993@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Yunes Panahi
Full name of responsible person - Persian: دکتر یونس پناهی
Position - English: Academic Researcher
Position - Persian: محقق آکادمیک
Latest degree: specialist
Area of specialty/work: 41
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Baqiyatallah University of Medical Sciences, Molla Sadra Avenue, Tehran
Street address - Persian: تهران، خیابان ملاصدرا، دانشگاه علوم پزشکی بقیه الله
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1435916471
Phone: +98 21 8804 0060
Mobile: +98 912 327 0993
Fax:
Email: yunespanahi@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Vahidreza OstadmohammadiYunes Panahi Full name of responsible person - Persian: دکتر وحیدرضا استادمحمدییونس پناهی Position - English: Academic Researcher Position - Persian: محقق آکادمیک Latest degree: med_doctorspecialist Area of specialty/work: 3041 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Baqiyatallah University of Medical Sciences, Molla Sadra Avenue, Tehran Street address - Persian: تهران، خیابان ملاصدرا، دانشگاه علوم پزشکی بقیه الله City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1435916471 Phone: +98 21 8804 0060 Mobile: +98 912 633 9401327 0993 Fax: Email: vrom.1993yunespanahi@gmail.comyahoo.com Web page address:
Protocol summary
Study aim
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, 76 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
The updating process was done before publishing the paper to correct the registration information.
Acronym
IRCT registration information
IRCT registration number:IRCT20170513033941N72
Registration date:2020-06-23, 1399/04/03
Registration timing:prospective
Last update:2022-07-11, 1401/04/20
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
2021-12-24, 1400/10/03
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 University of Medical Sciences
Street address
Baqiyatallah University of Medical Sciences, 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 University of Medical Sciences, 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 University of Medical Sciences, 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. Yunes Panahi
Position
Academic Researcher
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 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. Yunes Panahi
Position
Academic Researcher
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
Email
yunespanahi@yahoo.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