Diet-glucose-gut Microbiome Net in Women With GDM

NCT04930276 | Unknown DMC

• 1 other identifier: JS-2842
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective cohort study was conducted to :1. explore the effective of diet intervention on blood glucose control; 2. observe the changeable composition of microbiota; 3. seek the possible microbiome intervened to prevent GDM.

Conditions

GDM; Blood Glucose; Pregnancy Outcome; Microbiota

Keywords

GDM; diet intervention; microbiome

Outcome Measures

Primary Outcomes (3)

• blood glucose

  Fast blood glucose and glycemic albumin will be combined to evaluate the efficiency of blood glucose control

  From enrollment to delivery

• the composition of gut microbiome

  the composition of gut microbiome in women with GDM and non-GDM

  From enrollment to delivery

• the glycemic qualification rate

  the frequency of ideal blood glucose values when participants monitor blood glucose by themselves every during every two weeks

  From enrollment to delivery

Secondary Outcomes (1)

• pregnancy outcome

  during delivery

Study Arms (2)

GDM group

EXPERIMENTAL

After participants are enrolled, they would be given medical nutrient treatment. Besides, they need have a follow-up visit every two weeks. Blood glucose, body weight, lifestyle and clinical information are collected. Blood samples and stool samples are collected in 28 and 32 pregnant weeks, respectively.

Other: Diet intervention

non-GDM group

OTHER

After participants enrollment, they also would be given medical nutrient treatment. And the other conditions are same as the group of GDM.

Other: Diet intervention

Interventions

Diet intervention OTHER

Professionals will guide participants to have a standard diet and require them to monitor blood glucose by themselves.

GDM group; non-GDM group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women who can have a regular labor inspection and delivery in the labor inspection hospital;
• The range of age is between 18 to 45 years;
• Pregnancy naturally and singleton pregnancy;
• Pregnant women with or without gestational diabetes diagnosed by oral glucose tolerance test at 24 to 28 weeks of pregnancy;
• Those who can skillfully use social software in mobile phones and obey the plan of follow-ups;
• Those who voluntary signing of informing consent.

You may not qualify if:

• Patients with pre-pregnancy diabetes or abnormal oral glucose tolerance test screening in early resulting from high risks or known pre-pregnancy glucose intolerance;
• Those who were estimated by endocrinology that their value of blood glucose is controlled by not only diet interventions but also drugs;
• Pregnant women who used antibiotics before 1 month enrollment ;
• Those who combined some metabolic diseases, such as hematological system diseases and nervous system diseases;
• Those who reject signing inform consent.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Department of ob gyn , Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Study Officials

• Liangkun Ma

  Chinese Academic of Medical Science & Peking Union Medical College Hospital

  STUDY CHAIR

Central Study Contacts

Liangkun Ma

CONTACT

13021961166; MaLiangKun@pumch.cn

Ying Tian

CONTACT

13121591988; 1220325578@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: June 18, 2021
• Study Start: March 5, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: June 18, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)