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The effects of omega-3 supplementation on inflammatory factors, oxidative stress biomarkers, pregnancy outcomes, and gene expression related to insulin, lipid, and inflammation in women with gestational diabetes

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History
# Registration date Revision Id
2 2019-09-20, 1398/06/29 104369
1 2018-12-19, 1397/09/28 71419
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  • Protocol summary

    Inclusion criteria: Patients with gestational diabetes mellitus aged 18 to 40 years. Exclusion criteria: Taking any supplements before the intervention, Needing insulin therapy, Placenta abruption, Pre-eclampsia, Eclampsia, Hypo and hyperthyroidism, Smokers
    Inclusion criteria: Patients with gestational diabetes mellitus aged 18 to 40 years. Exclusion criteria: Kidney or liver diseases, needing insulin therapy, pre-eclampsia, eclampsia, hypo and hyperthyroidism, smokers
    معیار ورود به مطالعه: بیماران مبتلا به دیابت بارداری در محدوده سنی 18 تا 40 سال. معیار خروج از مطالعه: مصرف هر نوع مکمل قبل از مداخله، نیاز به درمان با انسولین، دکولمان جفت ، پره اکلامپسی، اکلامپسی، کم کاری و یا پر کاری تیروئید، سیگاری ها
    معیار ورود به مطالعه: بیماران مبتلا به دیابت بارداری در محدوده سنی 18 تا 40 سال. معیار خروج از مطالعه: بیماری های کلیوی یا کبدی، نیاز به درمان با انسولین، پره اکلامپسی، اکلامپسی، کم کاری و یا پر کاری تیروئید، سیگاری ها

  • General information

    2018-07-22, 1397/04/31
    2018-08-03, 1397/05/12
    Exclusion criteria: Taking any supplements before the intervention
    Needing insulin therapy
    Placenta abruption
    Pre-eclampsia
    Eclampsia
    Hypo and hyperthyroidism
    Smokers
    Exclusion criteria: Kidney or liver diseases
    Needing insulin therapy
    Pre-eclampsia
    Eclampsia
    Hypo and hyperthyroidism
    Smokers
    معیار خروج از مطالعه: مصرف هر نوع مکمل قبل از مداخله
    نیاز به درمان با انسولین
    دکولمان جفت
    پره اکلامپسی
    اکلامپسی
    کم کاری و یا پر کاری تیروئید
    سیگاری ها
    معیار خروج از مطالعه: بیماری های کبدی یا کلیوی
    نیاز به درمان با انسولین
    پره اکلامپسی
    اکلامپسی
    کم کاری و یا پر کاری تیروئید
    سیگاری ها

  • Secondary outcomes

    #1
    Expressed levels of LDL-R gene
    Expressed levels of LDLR gene
    سطوح بیان LDL-R gene
    سطوح بیان LDLR gene
    #2
    Newborn's head circumference
    Expressed levels of IL-1 gene
    دور سر نوزادان
    سطوح بیان IL-1
    Delivery time
    At the beginning of the study and after 6 weeks of intervention
    زمان زایمان
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    Tape
    PCR
    متر نواری
    PCR
    #3
    Newborn's weight
    Insulin
    وزن نوزادان
    انسولین
    Delivery time
    At the beginning of the study and after 6 weeks of intervention
    زمان زایمان
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    Scale
    Elisa kit
    ترازو
    کیت الایزا
    #4
    Polyhydramnios
    Insulin resistance
    پلی هیدروآمونیوس
    مقاومت به انسولین
    End-of-trial
    At the beginning of the study and after 6 weeks of intervention
    انتهای مداخله
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    Sonography
    Calculation using HOMA formula
    سونوگرافی
    محاسبه با استفاده از فرمول HOMA
    #5
    Newborn length
    Total cholesterol
    قد نوزادان تازه متولد شده
    توتال کلسترول
    The first 24 h after birth
    At the beginning of the study and after 6 weeks of intervention
    24 ساعت اول بعد از تولد
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    Girth measuring tape
    Enzymatic kit
    متر نواری
    کیت آنزیمی
    #6
    empty
    Triglycerides
    empty
    تری گلیسرید
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #7
    empty
    HDL
    empty
    HDL
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #8
    empty
    LDL
    empty
    LDL
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #9
    empty
    FPG
    empty
    قندخون ناشتا
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #10
    empty
    VLDL
    empty
    VLDL
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی

Protocol summary

Study aim
Objective: The aim of this study is to determine the effects of omega-3 supplementation on inflammatory factors, oxidative stress biomarkers, pregnancy outcomes, and gene expression related to insulin, lipid, and inflammation in patients with gestational diabetes mellitus.
Design
Study design: Randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive omega-3 supplement (n=30) or placebo (n=30).
Settings and conduct
Among patients with gestational diabetes referred to Kosar Clinic affiliated to Arak University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with gestational diabetes mellitus aged 18 to 40 years. Exclusion criteria: Kidney or liver diseases, needing insulin therapy, pre-eclampsia, eclampsia, hypo and hyperthyroidism, smokers
Intervention groups
Intervention group: 2000 mg omega-3 daily (Barij Essence, Kashan, Iran) for 6 weeks orally. Control group: Placebo capsule (Barij Essence, Kashan, Iran), for 6 weeks orally.
Main outcome variables
Outcomes: Gene expression related to PPAR-γ (primary outcome) and pregnancy outcomes, inflammatory facors, oxidative stress biomarkers and gene expression related to inflammation and lipid (secondary outcomes) will be quantified at study baseline and end-of-trial.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170513033941N42
Registration date: 2018-12-19, 1397/09/28
Registration timing: retrospective

Last update: 2019-09-21, 1398/06/30
Update count: 1
Registration date
2018-12-19, 1397/09/28
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
2018-07-03, 1397/04/12
Expected recruitment end date
2018-08-03, 1397/05/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of omega-3 supplementation on inflammatory factors, oxidative stress biomarkers, pregnancy outcomes, and gene expression related to insulin, lipid, and inflammation in women with gestational diabetes
Public title
The effects of omega-3 supplementation in gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Patients with gestational diabetes mellitus. Individuals aged 18 to 40 years.
Exclusion criteria:
Exclusion criteria: Kidney or liver diseases Needing insulin therapy Pre-eclampsia Eclampsia Hypo and hyperthyroidism Smokers
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: 60
Randomization (investigator's opinion)
Randomized
Randomization description
To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<30 and ≥30 y). Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
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 Kosar clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Sardasht Avenue, Vice chancellor for research, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
1771844351
Approval date
2018-07-02, 1397/04/11
Ethics committee reference number
IR.ARAKMU.REC.1397.114

Health conditions studied

1

Description of health condition studied
Gestational diabetes mellitus
ICD-10 code
O24.4
ICD-10 code description
Gestational diabetes mellitus

Primary outcomes

1

Description
Expressed levels of PPAR-γ gene
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
PCR

Secondary outcomes

1

Description
Hs-CRP
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Elisa kit

2

Description
Nitric oxide
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Spectrophotometry

3

Description
Malondialdehyde
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Spectrophotometry

4

Description
Glutathione
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Spectrophotometry

5

Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Spectrophotometry

6

Description
Expressed levels of LDLR gene
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
PCR

7

Description
Expressed levels of VEGF gene
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
PCR

8

Description
Expressed levels of TGF-β gene
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
PCR

9

Description
Expressed levels of TNF gene
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
PCR

10

Description
Expressed levels of IL-1 gene
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
PCR

11

Description
Insulin
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Elisa kit

12

Description
Insulin resistance
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Calculation using HOMA formula

13

Description
Total cholesterol
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit

14

Description
Triglycerides
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit

15

Description
HDL
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit

16

Description
LDL
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit

17

Description
FPG
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit

18

Description
VLDL
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit

Intervention groups

1

Description
Intervention group: 2000 mg omega-3 daily (Barij Essence, Kashan, Iran) for 6 weeks orally.
Category
Treatment - Drugs

2

Description
Control group: Placebo capsule (Barij Essence, Kashan, Iran), for 6 weeks orally.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Kosar Clinic
Full name of responsible person
Mehri Jamilian
Street address
Emam Khomeyni Avenue, Arak
City
Arak
Province
Markazi
Postal code
1771844351
Phone
+98 31 5546 3378
Email
jamilian.m@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Mohammad Arjmandzadegan
Street address
Sardasht Avenue, Vice chancellor for research, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
1771844351
Phone
+98 31 5546 3378
Email
Arjmandzadegan.m@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
1771844351
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
1771844351
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
1771844351
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address

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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