Association Between Trimethylamine-N-oxide and Gestational Diabetes Mellitus
- Conditions
- Gestational Diabetes
- Interventions
- Other: Plasma TMAO concentration
- Registration Number
- NCT03415295
- Lead Sponsor
- Huazhong University of Science and Technology
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1694
- 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).
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Gestational diabetes mellitus Plasma TMAO concentration 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). Healthy pregnant control Plasma TMAO concentration 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.
- Primary Outcome Measures
Name Time Method Gestational diabetes mellitus During 24-32 weeks of gestation Glucose intolerance with onset or first diagnosis during pregnancy
- Secondary Outcome Measures
Name Time Method