Protocol summary
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Study aim
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The aim of this study is to determine the effects of soy-protein consumption on insulin resistance, inflammatory factor, biomarkers of oxidative stress and pregnancy outcomes in gestational diabetes.
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Design
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Study design: Randomized controlled clinical trial.
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Settings and conduct
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Population and sample size: 68 patients with GDM among pregnant women of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Pregnant women with GDM at 24-28 weeks' gestation and aged 18 to 40 years will be included in this study. Exclusion criteria: History of diabetes, renal impairment, chronic hypertension, hypothyroidism, eclampsia, patients with preeclampsia, intra uterine fetal death (IUFD), placenta abruption and preterm delivery and FPG more than 105 and blood glucose 2-hour postprandial more than 120 mg/dL.
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Intervention groups
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Intervention: Patients will be assigned to receive either soy-protein (intervention group: n=34) or the standard diet (control group: n=34).
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Main outcome variables
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Insulin and insulin resistance (primary outcome) and lipid, inflammatory factors and biomarkers of oxidative stress
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201412085623N31
Registration date:
2014-12-19, 1393/09/28
Registration timing:
retrospective
Last update:
2019-09-21, 1398/06/30
Update count:
1
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Registration date
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2014-12-19, 1393/09/28
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Kashan University of Medical Sciences
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Expected recruitment start date
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2014-09-06, 1393/06/15
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Expected recruitment end date
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2014-10-03, 1393/07/11
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of soy-protein consumption on insulin resistance, inflammatory factor, biomarkers of oxidative stress and pregnancy outcomes in gestational diabetes
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Public title
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Effect of diet therapy in treatment of gestational diabetes
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Pregnant women aged 18-40 years
Diagnosed with GDM at 24-28 weeks' gestation.
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
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Age
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From 18 years old to 40 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
68
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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At study baseline and after stratification for pre-intervention BMI and weeks of gestation, subjects will be randomly divided into two groups to take either soy-protein supplements (n=34) or the standard diet (n=34).
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2014-09-05, 1393/06/14
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Ethics committee reference number
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29/5/1/4229/پ
Health conditions studied
1
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Description of health condition studied
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Diabetes mellitus in pregnancy
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ICD-10 code
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O24.9
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ICD-10 code description
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Diabetes mellitus in pregnancy, unspecified
Primary outcomes
1
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Description
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Insulin
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Elisa kit
2
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Description
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Insulin resistance
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Calculation using HOMA formula
Secondary outcomes
1
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Description
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Total antioxidant capacity
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
2
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Description
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Triglycerides
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Enzymatic
3
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Description
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Cholesterol
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Enzymatic
4
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Description
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Glutathione
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
5
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Description
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Malondialdehyde
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
6
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Description
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Hs-CRP
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Elisa
7
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Description
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HDL
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Enzymatic kit
8
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Description
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LDL cholesterol
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Enzymatic kit
9
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Description
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Nitric Oxide
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
10
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Description
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Newborn's weight
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Timepoint
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Delivery time
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Method of measurement
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Scale
11
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Description
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Newborn's head circumference
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Timepoint
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Delivery time
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Method of measurement
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Tape
12
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Description
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Polyhydramnios
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Timepoint
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End-of-trial
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Method of measurement
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Sonographic
13
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Description
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Newborn's length
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Timepoint
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Delivery time
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Method of measurement
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Tape
14
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Description
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Newborn's bilirubin
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Timepoint
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Delivery time
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Method of measurement
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Enzymatic kit
15
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Description
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Apgar score
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Timepoint
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Delivery time
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Method of measurement
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Clinical observation
16
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Description
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Newborns' hypoglycemia
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Timepoint
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After delivery
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Method of measurement
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Enzymatic kit
17
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Description
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Preterm delivery
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Timepoint
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After delivery
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Method of measurement
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Medical record
18
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Description
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Maternal pre-eclampsia
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Timepoint
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After delivery
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Method of measurement
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Medical record
19
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Description
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Maternal hospitalization
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Timepoint
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After delivery
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Method of measurement
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Medical record
20
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Description
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Newborns' hospitalization
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Timepoint
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After delivery
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Method of measurement
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Medical record
Intervention groups
1
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Description
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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
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Category
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Treatment - Drugs
2
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Description
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Control group: Standard diet, 0.8 g/kg protein (70% animal and 30% vegetable proteins), daily for 6 weeks
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available