Characteristic and Modulation of Gut Microbiota on the Consequences of Pregnancy

Gestational Diabetes Mellitus Clinical Trial

Official title:

Characteristic and Modulation of Gut Microbiota on the Consequences of Pregnancy-based on the Maternal and Offspring Health Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04190511
• Other study ID #: 2017-KY-015-01
• Status: Completed
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2021
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Since the incidence of maternal obesity and gestational diabetes mellitus (GDM) is on the rise globally, how to improve the intrauterine environment of the offspring and prevent obesity and metabolic diseases from the early life has become a medical research. Since 2012, journals such as Nature and Science have reported that intestinal micro-ecological environments composed of intestinal microbes and their interactions are involved in human body and energy metabolism, and a variety of metabolic diseases including obesity and type 2 diabetes mellitus (T2DM). The incidence is closely related. Although intestinal microbes have an important impact on human health, the research on intestinal microecology during pregnancy is still in its infancy. The current research is still unclear about the relationship between intestinal microecology and pregnancy outcomes and whether it can be a potential target for regulating maternal metabolism and fetal intrauterine environment. Therefore, this study aims to regulate overweight/obese pregnant women by using prebiotic-containing dairy products to explore the effects of interventions targeting intestinal microbes on glucose and lipid metabolism, insulin resistance and risk of GDM in overweight/obese pregnant women. In order to improve the intrauterine environment and reduce the risk of fetal diseases. It is of great significance and value to improve the quality of the birth population in China and to alleviate the medical economic burden caused by obesity and metabolic diseases.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Age 18 ~ 45 years

• single pregnancy

• enrollment week 8-12 + 6 weeks (based on the last menstrual period or B-ultrasound monitoring)

• BMI = 25 kg / m2

• living in Beijing for at least 5 years

Exclusion Criteria:

• Taking antibiotics, probiotics or prebiotics

• smoking regularly

• drinking alcohol

• assisted fertility technology conception

• mental illness who were unable to answer questions correctly or were unwilling to conduct questionnaire surveys

• history of bariatric surgery

• not following dietary recommendations

• Lactose intolerance

• milk protein allergy

• pre-pregnancy hypertension, diabetes, Hyperlipidemia, hepatitis, nephritis, gastrointestinal diseases (chronic gastritis, enteritis, gastric ulcer and duodenal ulcer, etc.) and a history of infectious diseases (hepatitis, tuberculosis, etc.).

Related Conditions & MeSH terms

• Adverse Pregnancy Outcomes
• Diabetes, Gestational
• Gestational Diabetes Mellitus
• Gut Microbiota
• Medical Nutrition Therapy
• Overweight
• Overweight/Obese

Intervention

Dietary Supplement:
• Prebiotic-containing dairy
The trained dietitian gives guidance on diet, exercise, and weight gain during pregnancy based on the Maternal Dietary Guidelines and Dietary Pagoda recommendations developed by the Chinese Institute of Maternal and Child Nutrition. On this basis, intervention was carried out using prebiotic-containing dairy products (200g/day).
• Dietary intervention
The trained dietitian gives guidance on diet, exercise, and weight gain during pregnancy based on the Maternal Dietary Guidelines and Dietary Pagoda recommendations developed by the Chinese Institute of Maternal and Child Nutrition.

Locations

Country	Name	City	State
China	Beijing Obstetrics and Gynecology Hospital,Capital Medical University	Beijing	Chaoyang

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of gestational diabetes mellitus	The diagnose of GDM based on the result of OGTT according to IADPSG criterion in 24 to 28 weeks. We will compare the incidence of GDM in these three groups.	Up to 28 weeks
Primary	Weight change during pregnancy	We asked pregnant woman to weigh their weight using the same weighing scale in the morning of the inspection day after urinating and tell the obstetrician to record. Compare the weight gain during pregnancy among three groups.	During pregnancy, an average of 38 weeks