Effect of diet therapy in treatment of gestational diabetes

Effect of soy-protein consumption on insulin resistance, inflammatory factor, biomarkers of oxidative stress and pregnancy outcomes in gestational diabetes

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201412085623N31

Enrollment

Registered

2014-12-19

Start date

2014-09-06

Completion date

Unknown

Last updated

2019-10-07

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

Conditions

Diabetes mellitus in pregnancy. Diabetes mellitus in pregnancy, unspecified

Interventions

Intervention 1: Intervention group: Soy-protein diet, 0.8 g/kg protein (35% animal protein, 35% soy protein, and 30% other vegetable proteins), daily for 6 weeks. Intervention 2: Control group: Standa

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Pregnant women aged 18-40 years Diagnosed with GDM at 24-28 weeks' gestation.

Exclusion criteria

Exclusion criteria: History of diabetes Renal impairment Chronic hypertension Hypothyroidism Eclampsia Patients with preeclampsia Intra uterine fetal death (IUFD), placenta abruption and preterm delivery. FPG more than 105 and blood glucose 2-hour postprandial more than 120 mg/dL

Design outcomes

Primary

Measure	Time frame
Insulin. Timepoint: Baseline and End-of-trial. Method of measurement: Elisa kit.;Insulin resistance. Timepoint: Baseline and End-of-trial. Method of measurement: Calculation using HOMA formula.	—

Secondary

Measure	Time frame
Total antioxidant capacity. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry.;Triglycerides. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic.;Cholesterol. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic.;Glutathione. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry.;Hs-CRP. Timepoint: Baseline and End-of-trial. Method of measurement: Elisa.;HDL. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic kit.;LDL cholesterol. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic kit.;Nitric Oxide. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry.;Newborn's weight. Timepoint: Delivery time. Method of measurement: Scale.;Newborn's head circumference. Timepoint: Delivery time. Method of measurement: Tape.;Polyhydramnios. Timepoint: End-of-trial. Method of measurement: Sonographic.;Newborn's length. Timepoint: Delivery time. Method of measurement: Tape.;Newborn's bilirubin. Timepoint: Delivery time. Method of measurement: Enzymatic kit.;Apgar score. Timepoint: Delivery time. Method of measurement: Clinical observation.;Newborns' hypoglycemia. Timepoint: After delivery. Method of measurement: Enzymatic kit.;Preterm delivery. Timepoint: After delivery. Method of measurement: Medical record.;Maternal pre-eclampsia. Timepoint: After delivery. Method of measurement: Medical record.;Maternal hospitalization. Timepoint: After delivery. Method of measurement: Medical record.;Newborns' hospitalization. Timepoint: After delivery. Method of measurement: Medical record.	—

Measure

Time frame

Total antioxidant capacity. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry.;Triglycerides. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic.;Cholesterol. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic.;Glutathione. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry.;Hs-CRP. Timepoint: Baseline and End-of-trial. Method of measurement: Elisa.;HDL. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic kit.;LDL cholesterol. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic kit.;Nitric Oxide. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry.;Newborn's weight. Timepoint: Delivery time. Method of measurement: Scale.;Newborn's head circumference. Timepoint: Delivery time. Method of measurement: Tape.;Polyhydramnios. Timepoint: End-of-trial. Method of measurement: Sonographic.;Newborn's length. Timepoint: Delivery time. Method of measurement: Tape.;Newborn's bilirubin. Timepoint: Delivery time. Method of measurement: Enzymatic kit.;Apgar score. Timepoint: Delivery time. Method of measurement: Clinical observation.;Newborns' hypoglycemia. Timepoint: After delivery. Method of measurement: Enzymatic kit.;Preterm delivery. Timepoint: After delivery. Method of measurement: Medical record.;Maternal pre-eclampsia. Timepoint: After delivery. Method of measurement: Medical record.;Maternal hospitalization. Timepoint: After delivery. Method of measurement: Medical record.;Newborns' hospitalization. Timepoint: After delivery. Method of measurement: Medical record.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZatollah Asemi

Kashan University of Medical Sciences

asemi_r@yahoo.com+98 31 5562 0608

Outcome results

None listed

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