Effects of Gestational Diabetes Mellitus on Children

NCT03997396 | Unknown

• 1 other identifier: LC
• Study Type: observational
• Target: 510
• Locations: 1 country
• Sites: 1

Brief Summary

Abstract Gestational diabetes mellitus (GDM) refers to different degrees of glucose intolerance or impaired glucose tolerance,which are commonly found on non-diabetic persons during pregnancy.GDM is an important public health issue that has a huge impact on children's health.According to statistics,the global occurrence of GDM in 2017 was as high as 16.2%.As well as lifestyle changes that are leading to an increased number of women with overweightness and obesity,the increasing number of"older mothers"responding to the second-child policy are raising up the percentile of GDM by the year.infancy and pre-school age are the important stages of physical growth and psychomotor development.At present,there are few domestic and International studies on the impact of GDM on the health of children,and the conclusions are not the same.There is a lack of long-term follow-up and Chinese samples. This study focuses on the current new hotspot in the research of the children's health problems, based on the 1000-day life concept and theory of DOHaD. Prospective cohort study methods and real-world studies were used. To study and clarify the effect of GDM on the neuropsychological development and physical growth indicators of children in China, and further explore the possible mechanism of action and the related indicators of predictive value, looking for possible early intervention targets. The results are expected to expand the data sources of this type of research in China, improve the data quality and clarify the characteristics of this type of population in China, and provide data support for the revision of maternal and child health related policies.

Conditions

Gestational Diabetes Mellitus; Children

Keywords

gestational diabetes mellitus; children; neuropsychological; physique growth

Outcome Measures

Primary Outcomes (2)

• Changes in Peabody Developmental Motor Scales 2(PDMS-2) test results within 6 months of age

  The PDMS-2 test performed at the age of 1 month,3 months,6 months, to compare the differences in test results between the children of the GDM group and the non-GDM group.The PDMS-2 scale included two relatively independent parts, gross motion assessment Scale and fine motion assessment scales. The gross motion assessment scale for infants younger than 1 years of age tests the ability of three areas: reflexes, stationary and locomotion,the fine motion assessment scale tests grasping,visual-motor Integration.The results are expressed in terms of gross motor quotient (GMQ),fine motor quotient (FMQ),and total motor quotient (TMQ).There are seven grades according to quotient(MQ is excellent between 131 and 165, MQ is good between 121 and 130, MQ is medium up between 111 and 120，MQ is medium between 90 and 100，MQ is medium down between 80 and 89, MQ is poor between 70 and 79, MQ is very poor between 35 and 69).

  6 months

• Changes in Gesell developmental scale test results within 6 months of age

  The Gesell developmental scale test was performed at the age of 6 months,12 months,24 months,36 months,48 months,60 months and 72 months,to compare the differences in test results between the children of the GDM group and the non-GDM group.The Gesell developmental scale mainly measures five areas:adaptive behavior, gross motor, fine motor, Language behavior,personal-social behavior, the evaluation finally calculates the developmental quotient (DQ) of each area. Diagnostic criteria: DQ is more than or equal to 86 is normal, DQ is marginal between 76 and 85, DQ is mild mental retardation between 55 and 75, DQ is moderate mental retardation between 40 and 54, DQ is severe mental retardation between 25 and 39, and DQ is less than or equal to 25 is extremely severe mental retardation.

  72 months

Secondary Outcomes (10)

• Change of weight for height Z-score(WHZ)

  72 months

• Change of the height for age Z-score(HAZ)blood routines

  72 months

• Change of the BMI for Age Z-score(BAZ)

  72 months

• Change of the weight for Age Z-score(WAZ)

  72 months

• Changes in hemoglobin

  72 months

Study Arms (2)

the DGM group

The subject recruitment was implemented in the obstetrics department of the First People's Hospital of Chongqing Liangjiang New Area, China. 255 pregnant women diagnosed with GDM by IADPSG2010 standard and their children will be enrolled into the GDM group.

the Non-GDM group

In the obstetrics department of Chongqing First People's Hospital of Liangjiang New Area,China,the healthy pregnant women and delivery children in the same period were enrolled into the non-GDM group in a 1:1 ratio.

Eligibility Criteria

• Age: 1 Month - 72 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

In the obstetrics department of the First People's Hospital of Chongqing Liangjiang New Area,China, the pregnant women diagnosed as GDM by IADPSG2010 standard and delivery children were enrolled into the GDM group, and the healthy pregnant women and delivery children in the same period were enrolled into the non-GDM group according to 1:1 ratio.

You may qualify if:

• term infant;
• Apgar score\>=7 at birth；
• single birth;
• no obvious birth defects;
• no other perinatal diseases that seriously affecting growth and development;
• no congenital or genetic metabolic diseases that affect intelligence development;

You may not qualify if:

• mother with type 1 or type 2 diabetes before pregnancy;
• the mother had no OGTT diagnosis results and was not diagnosed in strict accordance with the diagnostic criteria of GDM;
• the mother had suffered from severe acute and chronic infectious diseases;
• the mother has other pregnancy complications during pregnancy (hypertensionkidney disease,cardiovascular disease,liver disease,thyroid-related disease,cholestasis,severe anemia,etc.);
• Mother's age\>35 years old;
• the infants developed diseases that severely affected metabolism or normal growth and development during the follow-up.

Sponsors & Collaborators

• Chen Li: lead

Study Sites (1)

Growth, Development and Mental health of Children and Adolescence Center

Chongqing, Chongqing Municipality, 400014, China

RECRUITING

Related Publications (8)

• Cho NH, Shaw JE, Karuranga S, Huang Y, da Rocha Fernandes JD, Ohlrogge AW, Malanda B. IDF Diabetes Atlas: Global estimates of diabetes prevalence for 2017 and projections for 2045. Diabetes Res Clin Pract. 2018 Apr;138:271-281. doi: 10.1016/j.diabres.2018.02.023. Epub 2018 Feb 26.

  PMID: 29496507 BACKGROUND

• Gao C, Sun X, Lu L, Liu F, Yuan J. Prevalence of gestational diabetes mellitus in mainland China: A systematic review and meta-analysis. J Diabetes Investig. 2019 Jan;10(1):154-162. doi: 10.1111/jdi.12854. Epub 2018 May 27.

  PMID: 29683557 BACKGROUND

• Xiang AH. Association of Maternal Diabetes With Autism in Offspring. JAMA. 2017 Feb 7;317(5):537-538. doi: 10.1001/jama.2016.20122. No abstract available.

  PMID: 28170476 BACKGROUND

• Torres-Espinola FJ, Berglund SK, Garcia S, Perez-Garcia M, Catena A, Rueda R, Saez JA, Campoy C; PREOBE team. Visual evoked potentials in offspring born to mothers with overweight, obesity and gestational diabetes. PLoS One. 2018 Sep 12;13(9):e0203754. doi: 10.1371/journal.pone.0203754. eCollection 2018.

  PMID: 30208080 BACKGROUND

• Lahat E, Heyman E, Livne A, Goldman M, Berkovitch M, Zachor D. Iron deficiency in children with attention deficit hyperactivity disorder. Isr Med Assoc J. 2011 Sep;13(9):530-3.

  PMID: 21991711 BACKGROUND

• Hanson M. The birth and future health of DOHaD. J Dev Orig Health Dis. 2015 Oct;6(5):434-7. doi: 10.1017/S2040174415001129. Epub 2015 May 25.

  PMID: 26004094 BACKGROUND

• Liu G, Li N, Sun S, Wen J, Lyu F, Gao W, Li L, Chen F, Baccarelli AA, Hou L, Hu G. Maternal OGTT glucose levels at 26-30 gestational weeks with offspring growth and development in early infancy. Biomed Res Int. 2014;2014:516980. doi: 10.1155/2014/516980. Epub 2014 Feb 13.

  PMID: 24689042 BACKGROUND

• Li C, Zhou P, Cai Y, Peng B, Liu Y, Yang T, Li Y, Hu Y, Fu Y, Wang Z, Peng H, Zhang Y, Chen J, Li T, Chen L. Associations between gestational diabetes mellitus and the neurodevelopment of offspring from 1 month to 72 months: study protocol for a cohort study. BMJ Open. 2020 Nov 24;10(11):e040305. doi: 10.1136/bmjopen-2020-040305.

  PMID: 33234643 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Li Chen, MD

  Children's Hospital of Chongqing Medical University

  STUDY DIRECTOR

• Chao Li, MB

  Chongqing First People's Hospital of Liangjiang New Area

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Chen, MD

CONTACT

(+86)136 7762 0103; chenli2012@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice Director,Professor

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 25, 2019
• Study Start: June 1, 2019
• Primary Completion: May 30, 2025
• Study Completion: September 30, 2025
• Last Updated: January 29, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)