Effect of supplementation in treatment of women with gestational diabetes

Clinical trial of the effect of fish oil supplementation compared with the placebo on levels of gene expression related with glycemic control and inflammatory factors in women with gestational diabetes

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201610015623N90

Enrollment

Registered

2016-10-11

Start date

2016-07-26

Completion date

Unknown

Last updated

2019-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational diabetes. Diabetes mellitus in pregnancy, unspecified

Interventions

Intervention 1: Intervention group: 1000 mg fish oil (Barij Essence, Kashan, Iran), twice a day, for 6 weeks orally. Intervention 2: Control group: Placebo (Barij Essence, Kashan, Iran), twice a day,

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Patients with gestational diabetes Aged 18 to 40 years

Exclusion criteria

Exclusion criteria: Taking fish oil supplements Insulin therapy Placenta abruption Pre-eclampsia Eclampsia Hypo and hyperthyroidism Smokers

Design outcomes

Primary

Measure	Time frame
PPAR-?. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: PCR.	—

Secondary

Measure	Time frame
Gene expression of interleukin 1. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: PCR.;Gene expression of tumor necrosis factor alpha. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: PCR.;Gene expression of interleukin 8. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: PCR.;Gene expression of LDLR. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: PCR.;Fasting plasma glucose. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;Insulin. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: ELISA kit.;Insulin resistance. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Calculation using HOMA formula.;Triglycerides. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;High-sensitivity C-reactive protein. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: ELISA kit.;Newborn's head circumference. Timepoint: Delivery time. Method of measurement: Tape.;Polyhydramnios. Timepoint: End-of-trial. Method of measurement: Sonographic.;Apgar score. Timepoint: Delivery time. Method of measurement: Clinical observation.;Preterm delivery. Timepoint: After delivery. Method of measurement: Medical record.;Maternal pre-eclampsia. Timepoint: After delivery. Method of measurement: Medical record.;Newborn's length. Timepoint: Delivery time. Method of measurement: Delivery time.;Newbo	—

Measure

Time frame

Gene expression of interleukin 1. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: PCR.;Gene expression of tumor necrosis factor alpha. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: PCR.;Gene expression of interleukin 8. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: PCR.;Gene expression of LDLR. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: PCR.;Fasting plasma glucose. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;Insulin. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: ELISA kit.;Insulin resistance. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Calculation using HOMA formula.;Triglycerides. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;High-sensitivity C-reactive protein. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: ELISA kit.;Newborn's head circumference. Timepoint: Delivery time. Method of measurement: Tape.;Polyhydramnios. Timepoint: End-of-trial. Method of measurement: Sonographic.;Apgar score. Timepoint: Delivery time. Method of measurement: Clinical observation.;Preterm delivery. Timepoint: After delivery. Method of measurement: Medical record.;Maternal pre-eclampsia. Timepoint: After delivery. Method of measurement: Medical record.;Newborn's length. Timepoint: Delivery time. Method of measurement: Delivery time.;Newbo

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZatollah Asemi

Kashan University of Medical Sciences

asemi_z@kaums.ac.ir+98 31 5546 3378

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026