Protocol summary
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Study aim
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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.
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Design
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Randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive N-acetylcysteine (n=38) or placebo (n=38).
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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 16 weeks prior to enrollment in the study; hypersensitivity to the study medication; pregnancy or breastfeeding, diabetes mellitus.
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Intervention groups
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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.
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Main outcome variables
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Insulin resistance (primary outcome) and lipid profiles, oxidative damage biomarkers, hs-CRP, and serum adiponectin levels (secondary outcomes)
General information
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Reason for update
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The updating process was done before publishing the paper to correct the registration information.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170513033941N72
Registration date:
2020-06-23, 1399/04/03
Registration timing:
prospective
Last update:
2022-07-15, 1401/04/24
Update count:
2
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Registration date
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2020-06-23, 1399/04/03
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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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2020-06-28, 1399/04/08
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Expected recruitment end date
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2021-12-24, 1400/10/03
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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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Comparing the effects of N-acetylcysteine and placebo on metabolic profiles and serum adiponectin levels in patients with metabolic syndrome
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Public title
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N-acetylcysteine administration in treatment of metabolic syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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 16 weeks prior to enrollment in the study
Hypersensitivity to the study medication
Pregnancy or breastfeeding
Diabetes mellitus
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Age
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From 25 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:
76
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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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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2020-06-08, 1399/03/19
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Ethics committee reference number
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IR.BMSU.REC.1399.188
Health conditions studied
1
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Description of health condition studied
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Metabolic syndrome
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ICD-10 code
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E88.81
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ICD-10 code description
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Metabolic syndrome
Primary outcomes
1
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Description
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Insulin resistance
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Calculation using the Homeostasis Model Assessment (HOMA) formula
Secondary outcomes
1
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Description
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Insulin
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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ELISA kit
2
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Description
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Fasting plasma glucose
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
3
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Description
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Total cholesterol
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
4
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Description
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Triglycerides
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
5
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Description
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High-density lipoprotein (HDL)
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
6
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Description
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Low-density lipoprotein (LDL)
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
7
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Description
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High-sensitivity C-reactive Protein (hs-CRP)
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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ELISA kit
8
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Description
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Malondialdehyde
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
9
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Description
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Glutathione
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
10
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Description
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Total antioxidant capacity
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
11
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Description
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Adiponectin
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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ELISA kit
Intervention groups
1
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Description
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Intervention group: N-acetylcysteine 600 mg Tablet (Osve Pharmaceutical Co., Tehran, Iran), orally, three times a day, for 12 weeks.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo Tablet (Osve Pharmaceutical Co., Tehran, Iran), three times a day, orally, for 12 weeks.
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Category
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Placebo
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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Bagheiat-allah 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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Undecided - It is not yet known if there will be a plan to make this available
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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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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available