Maternal Endocrine System and Metabolic Diseases and Offspring Health: Prediction Within a Birth Cohort

NCT05952739 | Unknown

• 1 other identifier: 2022-PUMCH-C-019
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of metabolic diseases in pregnant women is increasing rapidly, and the risk of metabolic diseases in children is also increasing. However, there is a lack of early predictive indicators for metabolic diseases in children, which cannot effectively prevent and treat metabolic diseases in children. This project will establish a clinical database and a long-term follow-up biological bio-bank through the follow-up of metabolic indicators before and during pregnancy, and form an early warning system for the effects of maternal endocrine and metabolic diseases on the metabolism of offspring. It will not only help to warn the impact of maternal endocrine system and metabolic diseases on the metabolism of offspring, but also build a transformation platform for the study of maternal endocrine and metabolic diseases and metabolic health of offspring, which has important clinical value for curbing the rapid growth of metabolic diseases such as diabetes and obesity in China. It is expected to provide an important theoretical basis for the window period of prevention and treatment of endocrine and metabolic diseases in China.

Conditions

Thyroid Dysfunction; Diabetes Mellitus

Keywords

Hyperglycemia during pregnancy; Thyroid Dysfunction During Pregnancy; Offspring metabolic diseases

Outcome Measures

Primary Outcomes (4)

• Gestational diabetes mellitus

  Hyperglycemia during pregnancy; 50 participants with hyperglycemia during pregnancy

  Measure blood glucose up to 28 weeks of pregnancy

• Thyroid dysfunction during pregnancy

  Slightly higher TSH or positive TPOAb; 140 participants with thyroid dysfunction during pregnancy

  Measure thyroid function up to 28 weeks of pregnancy

• Abnormal metabolism of offspring

  Abnormal birth weight，blood sugar etc; 300 participants

  1 year

• Diabetes mellitus complicating pregnancy

  Hyperglycemia during pregnancy; 50 participants with hyperglycemia during pregnancy

  Measure blood glucose up to 28 weeks of pregnancy

Study Arms (2)

Disease group

No interventions

Control group

No interventions

Eligibility Criteria

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

Study Population

Women with metabolic disease before or during pregnancy and control group

You may not qualify if:

• Twin or multiple pregnancy
• Severe pregnancy complications
• Complicated with important heart, liver, kidney, blood system and autoimmune diseases before pregnancy
• Associated with other diseases that may affect intestinal flora or metabolomics, including inflammatory bowel disease, irritable bowel syndrome, celiac disease, etc.
• Gastrointestinal and biliary surgeries, including bariatric surgery and cholecystectomy
• History of smoking, alcoholism, narcotic drug use
• For women who keep stool samples: antibiotics within 2 months of specimen collection: probiotics within 1 week of specimen collection: take oral drugs that may affect intestinal flora.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Key Laboratory of Endocrinology, Ministry of Health, Department of Endocrinology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, , China

Beijing, 100730, China

RECRUITING

Related Publications (11)

• Sun H, Saeedi P, Karuranga S, Pinkepank M, Ogurtsova K, Duncan BB, Stein C, Basit A, Chan JCN, Mbanya JC, Pavkov ME, Ramachandaran A, Wild SH, James S, Herman WH, Zhang P, Bommer C, Kuo S, Boyko EJ, Magliano DJ. IDF Diabetes Atlas: Global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045. Diabetes Res Clin Pract. 2022 Jan;183:109119. doi: 10.1016/j.diabres.2021.109119. Epub 2021 Dec 6.

  PMID: 34879977 BACKGROUND

• Osmond C, Barker DJ. Fetal, infant, and childhood growth are predictors of coronary heart disease, diabetes, and hypertension in adult men and women. Environ Health Perspect. 2000 Jun;108 Suppl 3(Suppl 3):545-53. doi: 10.1289/ehp.00108s3545.

  PMID: 10852853 BACKGROUND

• Xiao X, Zhang ZX, Cohen HJ, Wang H, Li W, Wang T, Xu T, Liu A, Gai MY, Ying S, Schmitz O, Yi Z. Evidence of a relationship between infant birth weight and later diabetes and impaired glucose regulation in a Chinese population. Diabetes Care. 2008 Mar;31(3):483-7. doi: 10.2337/dc07-1130. Epub 2007 Dec 10.

  PMID: 18070988 BACKGROUND

• Rawal S, Olsen SF, Grunnet LG, Ma RC, Hinkle SN, Granstrom C, Wu J, Yeung E, Mills JL, Zhu Y, Bao W, Ley SH, Hu FB, Damm P, Vaag A, Tsai MY, Zhang C. Gestational Diabetes Mellitus and Renal Function: A Prospective Study With 9- to 16-Year Follow-up After Pregnancy. Diabetes Care. 2018 Jul;41(7):1378-1384. doi: 10.2337/dc17-2629. Epub 2018 May 4.

  PMID: 29728364 BACKGROUND

• Kooijman MN, Kruithof CJ, van Duijn CM, Duijts L, Franco OH, van IJzendoorn MH, de Jongste JC, Klaver CC, van der Lugt A, Mackenbach JP, Moll HA, Peeters RP, Raat H, Rings EH, Rivadeneira F, van der Schroeff MP, Steegers EA, Tiemeier H, Uitterlinden AG, Verhulst FC, Wolvius E, Felix JF, Jaddoe VW. The Generation R Study: design and cohort update 2017. Eur J Epidemiol. 2016 Dec;31(12):1243-1264. doi: 10.1007/s10654-016-0224-9. Epub 2017 Jan 9.

  PMID: 28070760 BACKGROUND

• Lv H, Diao F, Du J, Chen T, Meng Q, Ling X, Li H, Song C, Xi Q, Jiang Y, Xu Y, Tao S, Huang L, Wen M, Peng M, Liu C, Lu Q, He Y, Yin Y, Liu X, Xu B, Han X, Zhou K, Jiang T, Zhao Y, Ma H, Jin G, Xia Y, Liu J, Lin Y, Hu Z, Shen H. Assisted reproductive technology and birth defects in a Chinese birth cohort study. Lancet Reg Health West Pac. 2021 Jan 22;7:100090. doi: 10.1016/j.lanwpc.2020.100090. eCollection 2021 Feb.

  PMID: 34327418 BACKGROUND

• Wang YY, Li Q, Guo Y, Zhou H, Wang QM, Shen HP, Zhang YP, Yan DH, Li S, Chen G, Zhou S, He Y, Yang Y, Peng ZQ, Wang HJ, Ma X. Ambient temperature and the risk of preterm birth: A national birth cohort study in the mainland China. Environ Int. 2020 Sep;142:105851. doi: 10.1016/j.envint.2020.105851. Epub 2020 Jun 22.

  PMID: 32585501 BACKGROUND

• Zhou L, Li S, Zhang Q, Yu M, Xiao X. Maternal Exercise Programs Glucose and Lipid Metabolism and Modulates Hepatic miRNAs in Adult Male Offspring. Front Nutr. 2022 Mar 1;9:853197. doi: 10.3389/fnut.2022.853197. eCollection 2022.

  PMID: 35299765 BACKGROUND

• Liu J, Ding L, Zhai X, Wang D, Xiao C, Hui X, Sun T, Yu M, Zhang Q, Li M, Xiao X. Maternal Dietary Betaine Prevents High-Fat Diet-Induced Metabolic Disorders and Gut Microbiota Alterations in Mouse Dams and Offspring From Young to Adult. Front Microbiol. 2022 Apr 5;13:809642. doi: 10.3389/fmicb.2022.809642. eCollection 2022.

  PMID: 35479641 BACKGROUND

• Zhang Q, Sun X, Xiao X, Zheng J, Li M, Yu M, Ping F, Wang Z, Qi C, Wang T, Wang X. The effect of maternal chromium status on lipid metabolism in female elderly mice offspring and involved molecular mechanism. Biosci Rep. 2017 Apr 28;37(2):BSR20160362. doi: 10.1042/BSR20160362. Print 2017 Apr 30.

  PMID: 28320771 BACKGROUND

• Zhou L, Xiao X, Li M, Zhang Q, Yu M, Zheng J, Deng M. Maternal Exercise Improves High-Fat Diet-Induced Metabolic Abnormalities and Gut Microbiota Profiles in Mouse Dams and Offspring. Front Cell Infect Microbiol. 2020 Jun 17;10:292. doi: 10.3389/fcimb.2020.00292. eCollection 2020.

  PMID: 32626663 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Mother's blood, milk, urine, feces, placenta, fetal umbilical cord blood, and offspring's urine, feces

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Xinhua Xiao

  Key Laboratory of Endocrinology, Ministry of Health, Department of Endocrinology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100730, China

  STUDY DIRECTOR

Central Study Contacts

Xinhua Xiao

CONTACT

+86-10-139 1183 0085; xiaoxh2014@vip.163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 19, 2023
• Study Start: August 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)