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IRCT20170513033941N42 IRCT 2018-12-19 Arak University of Medical Sciences The effects of omega-3 supplementation in gestational diabetes 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 2018-07-03 anticipated 60 Complete https://irct.ir/trial/34360 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Gestational diabetes mellitus. Intervention 1: Intervention group: 2000 mg omega-3 daily (Barij Essence, Kashan, Iran) for 6 weeks orally. Intervention 2: Control group: Placebo capsule (Barij Essence, Kashan, Iran), for 6 weeks orally. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Undecided - It is not yet known if there will be a plan to make this available
public Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 1771844351 +98 31 5546 3378 asemi_z@kaums.ac.ir Kashan University of Medical Sciences scientific Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 1771844351 +98 31 5546 3378 asemi_z@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Patients with gestational diabetes mellitus. Individuals aged 18 to 40 years. 18 years 40 years Female Exclusion criteria: Kidney or liver diseases Needing insulin therapy Pre-eclampsia Eclampsia Hypo and hyperthyroidism Smokers O24.4 Gestational diabetes mellitus Treatment - Drugs Placebo 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. Expressed levels of PPAR-γ gene. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: PCR. Hs-CRP. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Elisa kit. Nitric oxide. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry. Malondialdehyde. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry. Glutathione. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry. Total antioxidant capacity. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry. Expressed levels of LDLR gene. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: PCR. Expressed levels of VEGF gene. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: PCR. Expressed levels of TGF-β gene. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: PCR. Expressed levels of TNF gene. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: PCR. Expressed levels of IL-1 gene. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: PCR. 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. Total cholesterol. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit. Triglycerides. 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. LDL. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit. FPG. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit. VLDL. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit. Arak University of Medical Sciences Approved 2018-07-02 Ethics committee of Arak University of Medical Sciences Sardasht Avenue, Vice chancellor for research, Arak University of Medical Sciences Arak Markazi Iran (Islamic Republic of)