Association Between Trimethylamine-N-oxide and Gestational Diabetes Mellitus

NCT ID: NCT03415295

Last Updated: 2018-01-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1694 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-08-01
• Study Completion Date: 2017-06-30

Brief Summary

Background: The microbiota-dependent metabolite trimethylamine-N-oxide (TMAO) has been reported as a novel and independent risk factor for the development of cardiovascular and metabolic diseases, but the association with gestational diabetes mellitus (GDM) remains unclear.

Objective: To investigate the association between plasma TMAO concentration and GDM in a two-phase study.

Design: The initial discovery phase included 866 pregnant women (433 GDM cases and 433 matched controls) in Wuhan China. Study participants were recruited from pregnant women who attended the outpatient clinics of the Department of Endocrinology, Tongji Hospital, to screen for GDM between August 2012 and April 2015, or pregnant women who visited the Hubei Maternal and Child Health Hospital or the Central Hospital of Wuhan for a routine antenatal checkup from May 2014 to November 2016. The inclusion criteria of participants were: age ≥ 20 years, gestational age between 24 and 32 weeks, no history of a diagnosis of diabetes or gestational diabetes, and no history of receiving pharmacological treatment known to affect glucose metabolism. An independent replication phase study was nested within an ongoing prospective cohort study, namely the Tongji Maternal and Child Health Cohort (TMCHC). Beginning in January 2013, women receiving prenatal care prior to 16 weeks of gestation were invited to join the TMCHC. Exclusion criteria included pre-pregnancy diabetes, clinically significant neurological, endocrinological or other systemic diseases and multiple pregnancies. All enrolled pregnant women received a regular prenatal checkup in hospital and underwent an oral glucose tolerance test (OGTT) during 24-32 weeks of gestation to screen for GDM. 276 members who developed GDM before May 2016 and had fasting blood collected before 20 weeks'gestation were included as cases in this analysis. Two controls were individually matched to each case from among women without GDM. These two studies were approved by the ethics committee of Tongji Medical College. All the participants gave informed written consent before they were included in the study. Plasma TMAO concentrations were determined by stable isotope dilution liquid chromatography with online electrospray ionization tandem mass spectrometry.

Conditions

Gestational Diabetes

Keywords

Trimethylamine-N-oxide; Gestational diabetes mellitus

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Gestational diabetes mellitus

Gestational diabetes mellitus (GDM) was diagnosed according to the American Diabetes Association criteria, which is based on the "one-step" approach recommended by the International Association of Diabetes and Pregnancy Study Groups. All women underwent a 75g OGTT in the morning after an overnight fast, with plasma glucose measurement fasting and at 1 and 2 hours. The criteria for GDM diagnosis was to have at least one abnormal value: Fasting glucose ≥ 5.1 mmol/L (92 mg/dL), 1 h glucose ≥ 10.0 mmol/L (180 mg/dL), 2 h glucose ≥ 8.5 mmol/L (153 mg/dL).

Plasma TMAO concentration

Intervention Type: OTHER

Plasma TMAO concentrations were determined by stable isotope dilution liquid chromatography with online electrospray ionization tandem mass spectrometry on an AB SCIEX 4500 triple quadrupole mass spectrometer

Healthy pregnant control

Pregnant women with fasting glucose \< 5.1 mmol/L (92 mg/dL), 1 h glucose \< 10.0 mmol/L (180 mg/dL) and 2 h glucose \< 8.5 mmol/L (153 mg/dL) were considered as healthy controls.

Plasma TMAO concentration

Intervention Type: OTHER

Plasma TMAO concentrations were determined by stable isotope dilution liquid chromatography with online electrospray ionization tandem mass spectrometry on an AB SCIEX 4500 triple quadrupole mass spectrometer

Interventions

Plasma TMAO concentration

Plasma TMAO concentrations were determined by stable isotope dilution liquid chromatography with online electrospray ionization tandem mass spectrometry on an AB SCIEX 4500 triple quadrupole mass spectrometer

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥ 20 years;
• Screened for GDM during 24-32 weeks of gestation;
• With fasting blood samples collected before 20 weeks of gestation (only for nested case-control subjects).

Exclusion Criteria

• History of a diagnosis of diabetes or gestational diabetes;
• History of receiving pharmacological treatment known to affect glucose metabolism;
• Clinically significant neurological, endocrinological or other systemic diseases and multiple pregnancies.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Liegang Liu

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liegang Liu

Role: STUDY_DIRECTOR

Department of Nutrition and Food Hygiene, School of Public Health, Huazhong University of Science and Technology

References

Li P, Zhong C, Li S, Sun T, Huang H, Chen X, Zhu Y, Hu X, Peng X, Zhang X, Bao W, Shan Z, Cheng J, Hu FB, Yang N, Liu L. Plasma concentration of trimethylamine-N-oxide and risk of gestational diabetes mellitus. Am J Clin Nutr. 2018 Sep 1;108(3):603-610. doi: 10.1093/ajcn/nqy116.

Reference Type: DERIVED

PMID: 30535087 (View on PubMed)

Other Identifiers

SZSM201511007

Identifier Type: -

Identifier Source: org_study_id