Objective: The aim of this study is to determine the effects of N-acetylcysteine administration on pregnancy outcomes and metabolic profiles in women with GDM.
Design
Study design: Randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive N-acetyl cystein (n=38) or placebo (n=38).
Settings and conduct
Among patients with GDM referred to Beheshti gynecology Clinic affiliated to Kashan University of Medical Sciences, 76 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Drugs and placebos are similar. Fasting blood samples will be taken at baseline and 6 weeks after the intervention. At the beginning and the end of the intervention: 6 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with gestational diabetes aged 18 to 40 years. Exclusion criteria: Overt diabetes mellitus, taking any supplements 3 months before the intervention, needing insulin therapy, Hypo and hyperthyroidism, Smokers, and Unwillingness to cooperate.
Intervention groups
Intervention group: Tab N-acetylcysteine 600 mg three times a day (Osve Pharmaceutical Co., Tehran, Iran), for 6 weeks orally. Control group: Tab Placebo three times a day (Osve Pharmaceutical Co., Tehran, Iran), for 6 weeks orally.
Main outcome variables
Outcomes: Insulin resistance (primary outcome) and lipid profiles, biomarkers of inflammation and oxidative stress, and pregnancy outcomes (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170513033941N71
Registration date:2020-04-21, 1399/02/02
Registration timing:registered_while_recruiting
Last update:2020-04-21, 1399/02/02
Update count:1
Registration date
2020-04-21, 1399/02/02
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
2020-02-04, 1398/11/15
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
Study of the effects of N-acetylcysteine administration on pregnancy outcomes and metabolic profiles in women with gestational diabetes mellitus
Public title
Effects of N-acetylcysteine administration in treatment of women with gestational diabetes mellitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with gestational diabetes mellitus.
Individuals aged 18 to 40 years.
Exclusion criteria:
Overt diabetes mellitus
Taking any supplements 3 months before the intervention
Needing insulin therapy
Hypo and hyperthyroidism
Smokers
Unwillingness to cooperate
Age
From 18 years old to 40 years old
Gender
Female
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 were 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 Beheshti Gynecology Clinic, who is not involved in the trial and not aware of random sequences, will be assigned 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 drug. After analyzing the data, packet codes will be decoded. Participants, investigators or 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 Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2020-02-03, 1398/11/14
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1398.126
Health conditions studied
1
Description of health condition studied
Gestational diabetes mellitus
ICD-10 code
O24.9
ICD-10 code description
Unspecified diabetes mellitus in pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Insulin resistance
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Calculation using HOMA formula
Secondary outcomes
1
Description
Insulin
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Elisa kit
2
Description
Total cholesterol
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
HDL
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
Triglycerides
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
5
Description
Hs-CRP
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Elisa kit
6
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Spectrophotometry
7
Description
Glutathione
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Spectrophotometry
8
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Spectrophotometry
9
Description
Newborn's head circumference
Timepoint
Delivery time
Method of measurement
Tape
10
Description
Newborn's weight
Timepoint
Delivery time
Method of measurement
Scale
11
Description
Polyhydramnios
Timepoint
End-of-trial
Method of measurement
Sonography
12
Description
Newborn length
Timepoint
The first 24 h after birth
Method of measurement
Girth measuring tape
Intervention groups
1
Description
Intervention group: Tab N-acetylcysteine 600 mg three times a day (Osve Pharmaceutical Co., Tehran, Iran), for 6 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Tab Placebo three times a day (Osve Pharmaceutical Co., Tehran, Iran), for 6 weeks orally.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Gynecology Clinic
Full name of responsible person
Dr. Zohreh Tabasi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
Tabasi.z@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Banafsheh
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
banafshe.hr@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Dr. Susan Asadpour
Position
Resident of gynecology and obstetrics
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
Asadpou.s@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Zohreh Tabasi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
Tabasi.z@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Zohreh Tabasi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
Tabasi.z@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