- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
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Gestační diabetes mellitus
Gestační diabetes mellitus (GDM) byl diagnostikován podle kritérií Americké diabetické asociace, která je založena na „jednostupňovém“ přístupu doporučeném Mezinárodní asociací pro studium diabetu a těhotenství.
Všechny ženy podstoupily 75g OGTT ráno po celonočním hladovění s měřením glukózy v plazmě nalačno a 1 a 2 hodiny.
Kritériem pro diagnózu GDM bylo mít alespoň jednu abnormální hodnotu: glukóza nalačno ≥ 5,1 mmol/l (92 mg/dl), 1 h glukóza ≥ 10,0 mmol/l (180 mg/dl), 2 h glukóza ≥ 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Gestational diabetes mellitus
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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Klinické studie na Gestační diabetes
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