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Preventive effect of fermentable fiber supplementation in the first and second trimester of pregnancy on gestational diabetes mellitus: a randomized, double-blind, controlled clinical study

Preventive effect of fermentable fiber supplementation in the first and second trimester of pregnancy on gestational diabetes mellitus: a randomized, double-blind, controlled clinical study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036575
Enrollment
Unknown
Registered
2020-08-24
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-14

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

Conditions

gestational diabetes mellitus

Interventions

experimental group:Fermented fiber, 20g / day (10g / time, twice a day), for 5 weeks
control group:Unfermented fiber, 20g / day (10g / time, twice a day), for 5 weeks

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Pregnant women with GDM high-risk factors were selected from October 2020 to May 2022 in our hospital obstetric outpatient card and regular prenatal examination. inclusion criteria: 1) Han women; 2) single pregnancy; 3) establishment of birth card before 20 weeks; 4) 75g oral glucose tolerance test (OGTT), serum insulin and glycosylated hemoglobin (A1C) were conducted at 24-28 weeks of pregnancy, HbA1c); 5) one or more of the following risk factors: older than 35 years old, overweight or obesity before pregnancy (BMI>25kg/m2), polycystic ovary syndrome, family history of diabetes, history of unexplained Intrauterine fetal death, stillbirth and abortion, history of fetal malformation, history of polyhydramnios, history of macrosomia, history of GDM, history of polyhydramnios, history of recurrent vulvovaginal candidiasis and the fetal development is greater than gestational age.

Exclusion criteria

Exclusion criteria: 1. Pre pregnancy diabetes mellitus (PGDM): including diabetes mellitus diagnosed before pregnancy, abdominal blood glucose = 7 mmol / L during the first prenatal examination, 75g OGTT for the first time, 2-hour postprandial blood glucose = 11.1mmol/l, typical hyperglycemia and hyperglycemia crisis symptoms, and at the same time, any blood glucose = 11.1mmol/l, glycosylated hemoglobin = 6.5% at the time of the first labor examination; 2. reproductive medicine means Pregnant women, including but not limited to in vitro artificial pregnancy, drug ovulation and other means; 3. chronic infectious diseases due to long-term use of antibiotics.

Design outcomes

Primary

MeasureTime frame
Incidence of GDM;

Secondary

MeasureTime frame
Incidence of insulin resistance;Incidence of adverse maternal and infant outcomes;Poor glycemic control;

Countries

China

Contacts

Public ContactXianming Xu

Shanghai General Hospital

xuxm11@163.com+86 13386259552

Outcome results

None listed

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