- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05146401
Associations of Plasma Fatty Acid Patterns With Gestational Diabetes Mellitus
Associations of Plasma Fatty Acid Patterns During Pregnancy With Gestational Diabetes Mellitus
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.
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Inclusion Criteria:
- Age ≥ 20 years;
- Gestational age at GDM screening ≥ 24 weeks;
- Singleton pregnancy;
- With enough plasma collected for fatty acids detection.
Exclusion Criteria:
- History of diabetes (including but not limited to GDM), cardiovascular disease, cancer or other systemic diseases;
- History of receiving pharmacological treatment known to affect glucose metabolism;
- Incomplete basic information.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
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Graviditetsdiabetes mellitus
Graviditetsdiabetes mellitus (GDM) diagnostiserades enligt American Diabetes Associations kriterier, som är baserad på "enstegs"-metoden som rekommenderas av International Association of Diabetes and Pregnancy Study Groups.
Alla kvinnor genomgick en 75g OGTT på morgonen efter en nattfasta, med plasmaglukosmätning fastande och vid 1 och 2 timmar.
Kriterierna för GDM-diagnos var att ha minst ett onormalt värde: Fasteglukos ≥ 5,1 mmol/L (92 mg/dL), 1 h glukos ≥ 10,0 mmol/L (180 mg/dL), 2 h glukos ≥ 8,5 mmol/ L (153 mg/dL).
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Plasma concentrations of fatty acids were measured by gas chromatography - mass spectrometry (Agilent 7890B gas chromatography coupled with an Agilent 5977A Series mass spectrometry).
Individual fatty acids with relative concentrations ≥ 0.05% were used to derive fatty acid patterns through principle components analysis.
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Healthy pregnant women
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.
Controls were randomly selected and individually matched to cases by age (± 2 years), gestational age (± 2 weeks) and parity.
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Plasma concentrations of fatty acids were measured by gas chromatography - mass spectrometry (Agilent 7890B gas chromatography coupled with an Agilent 5977A Series mass spectrometry).
Individual fatty acids with relative concentrations ≥ 0.05% were used to derive fatty acid patterns through principle components analysis.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Gestational diabetes mellitus
Tidsram: gestation age ≥ 24 weeks
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Glucose intolerance with onset or first diagnosis during pregnancy.
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.
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gestation age ≥ 24 weeks
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- PYL202111
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