NCT05146401

Associations of Plasma Fatty Acid Patterns With Gestational Diabetes Mellitus

Completed Last updated 6 December 2021

What this trial tests

trial testing Plasma fatty acid concentration in Gestational Diabetes in 434 participants. Completed in 30 June 2020.

Timeline

1 August 2012

Primary endpoint
30 April 2015

30 June 2020

Quick facts

Lead sponsor	Liegang Liu
Status	Completed
Study type	OBSERVATIONAL
Enrollment	434
Start date	1 August 2012
Primary completion	30 April 2015
Estimated completion	30 June 2020

Drugs / interventions tested

• Plasma fatty acid concentration

Conditions studied

• Gestational Diabetes — all drugs for Gestational Diabetes →

Sponsor

Liegang Liu

Who can join

Adults 21 to 43, female only, with Gestational Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Limited studies have explored the difference of fatty acid profile between women with and without gestational diabetes mellitus (GDM), and the results were inconsistent. Individual fatty acids tend to be interrelated because of the shared food sources and metabolic pathways. Thus, whether fatty acid patters during pregnancy were related to GDM odds needs further exploration.

Objective: We aim to identify plasma fatty acid patters during pregnancy and their associations with odds of gestational diabetes mellitus (GDM).

Design: A hospital-based case-control study was carried out in urban Wuhan, China from August 2012 to April 2015. Pregnant women who screened for GDM at the outpatient clinics of the Department of Endocrinology, Tongji Hospital were invited to participant in the study. The inclusion criteria were as follows: 1) age ≥ 20 years; 2) gestational age at GDM screening ≥ 24 weeks; 3) singleton pregnancy. We excluded women who met any of the following items: history of diabetes (including but not limited to GDM), cardiovascular disease, cancer or other systemic diseases; pharmacologic treatment or dietary supplement use that might influence glucose or lipids metabolism; accompanied by other pregnancy complications; blood sample hemolysis or insufficiency; incomplete basic information. The diagnosis of GDM can be made if one or more glucose values are above the cut points of 5.1, 10.0 and 8.5 mmol/L at fasting, 1 and 2 h during a 75-gram oral glucose tolerance test (OGTT). Controls were randomly selected and individually matched to cases by age (± 2 years), gestational age (± 2 weeks) and parity. Finally, 217 GDM cases and 217 matched controls were selected in this study. All participants gave written informed consent before enrolling in the study. Fasting blood samples (≥ 8 h overnight fasting) were collected using anticoagulant tubes and centrifuged at 3000 rpm for 5 min. Plasma were separated from blood cells and stored at -80 ℃ for further assay. We measured plasma concentrations of fatty acids by gas chromatography - mass spectrometry, and derived potential fatty acid patterns trough principle components analysis. Conditional logistic regression and restricted cubic spline model were used to evaluate the associations between individual fatty acids or fatty acid patterns and odds of GDM.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Associations of Plasma Fatty Acid Patterns During Pregnancy With Gestational Diabetes Mellitus.
   Li P, Hu S, Zhu Y, Sun T, et al · · 2022 · cited 5× · PMID 35600822 · DOI 10.3389/fnut.2022.836115