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Multiomics-based Prediction Model for GDM

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05078697
Collaborator
(none)
100
Enrollment
1
Location
23
Anticipated Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A prospective cohort study was conducted to :1. explore the relative biomarkers of related with the occurence and development; 2. develop a multiotimics prediction model for GDM.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Gestational diabetes mellitus (GDM) is one of the most complications during pregnancy and it is associated with many adverse outcomes especially when the pregnant women can't control blood glucose well. With economy develop rapidly, the occurence of GDM is about 15-20%. Recently, the research on GDM has gone into the molecular level, which is beneficial to diagnosis and treatment on GDM. Besides, the cost of hospitalization and treatment for adverse outcomes caused by GDM have caused a certain burden to pregnant women, their families and the whole country. Lifestyle management has the first-line for treatment on GDM, however, the situation of self-management on GDM isn't satisfactory. Therefore, our study aims to explore a model to predict GDM in advance and reduce the adverse outcomes and economy associated with GDM.

    The study plan to enroll 60 participants with hisk-risk of GDM and 40 normal participants. They are required sign the inform consent after deciding to participate the research. Furthermore, during early pregnancy (8-13 weeks), middle pregnancy (24-27 3 weeks) and late pregnancy (32-36 weeks), 6-8 weeks after delivery, blood, feces, urine, saliva samples were collected, and continuous blood glucose monitoring system were equipped, human component testing was performed. Follow up was performed to collect the first stool sample of the mother after delivery and faecal samples from the first to the fifth time after birth (the first five times within one week after birth, including hospitalization and discharge) .

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Exploratory Study on Gestational Diabetes Mellitus: Multiomics-based Prediction Model
    Actual Study Start Date :
    Apr 1, 2021
    Anticipated Primary Completion Date :
    Apr 1, 2022
    Anticipated Study Completion Date :
    Mar 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    early pregnancy women

    According to the 2020 high-risk population score model, participants with high risks for GDM and normal health participants will be enrolled into the study.

    Outcome Measures

    Primary Outcome Measures

    1. microbiota [At 8 to 13 gestational weeks]

      1.The composition of gut and saliva microbiota in women;2. The blood glucose level;3. The body composition value

    2. microbiota [At 24 to 28 gestational weeks]

      1.The composition of gut and saliva microbiota in women;2. The blood glucose level;3. The body composition value

    3. microbiota [At 32-36 gestational weeks]

      1.The composition of gut and saliva microbiota in women;2. The blood glucose level;3. The body composition value

    4. microbiota [At postpartum 42 days]

      1.The composition of gut and saliva microbiota in women;2. The blood glucose level;3. The body composition value; 4. The composition of gut in fetuses

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    All of following conditions must be met:

    • The range of pregnant week is between 8 to 13+6 weeks;

    • The range of age is between 20 to 45 years;

    • Pregnancy naturally and singleton pregnancy;

    • According to the 2020 GDM high-risk population scoring model, those who gets equal to or larger than 80 scores will be assigned to high-risk group and equal to or smaller than 20 scores to low-risk group;

    Exclusion Criteria:
    Meeting one of the following conditions will be excluded:

    • Smoking or drinking alcohols;

    • Pregnant women who used antibiotics before 1 month enrollment;

    • Combined with Chronic hepatitis, nephritis, chronic gastritis, gastric ulcer, chronic colitis, hyperthyroidism, hypothyroidism (except subclinical hypothyroidism) and blood diseases before pregnancy;

    • Pregnant women who has a long-term medication history;

    • Those who reject signing the inform consent;

    • Those who has participated other clinical trail in the same period

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of ob gyn , Peking Union Medical College Hospital Beijing Beijing China

    Sponsors and Collaborators

    • Peking Union Medical College Hospital

    Investigators

    • Study Chair: Liangkun Ma, Chinese Academic of Medical Science & Peking Union Medical College Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT05078697
    Other Study ID Numbers:
    • HS-2297
    First Posted:
    Oct 14, 2021
    Last Update Posted:
    Oct 14, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Peking Union Medical College Hospital
    GDM
    predictive model
    multiotimics

    Study Results

    No Results Posted as of Oct 14, 2021