Multiomics-based Prediction Model for GDM

NCT05078697 | Unknown DMC

• 1 other identifier: HS-2297
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

GDM

Keywords

GDM; predictive model; multiotimics

Outcome Measures

Primary Outcomes (4)

• microbiota

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

  At 8 to 13 gestational weeks

• microbiota

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

  At 24 to 28 gestational weeks

• microbiota

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

  At 32-36 gestational weeks

• microbiota

  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

  At postpartum 42 days

Study Arms (1)

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.

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

60 pregnant women who has high risk for GDM and 40 normal will be enrolled in this study.

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Department of ob gyn , Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood, feces, urine, saliva samples

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

Suhan Zhang

CONTACT

18611967191; hanhan1114@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: October 14, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: March 1, 2023
• Last Updated: October 14, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)