- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05267457
Associations of Plasma Vanadium Concentrations With Gestational Diabetes Mellitus
Background: Vanadium compounds have been shown to exert insulin-mimetic effects and thereby control glucose homeostasis. However, studies regarding the levels of vanadium and gestational diabetes mellitus (GDM) are limited and have inconsistent outcomes.
Objective: The aim of this study was to investigate the association of plasma vanadium concentrations with 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 and ≤ 43 years; 2) gestational age at GDM screening ≥ 24 weeks; 3) singleton pregnancy. The investigators 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; 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, 252 GDM cases and 252 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. Plasma vanadium concentrations were measured using inductively coupled plasma mass spectrometry. Conditional logistic regression and restricted cubic spline model were used to evaluate the associations between plasma vanadium and odds of GDM.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Age ≥ 20 and ≤ 43 years;
- Gestational age at GDM screening ≥ 24 weeks;
- Singleton pregnancy;
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 |
---|---|
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 vanadium concentrations were measured using inductively coupled plasma mass spectrometry (ICP-MS) (Agilent 7700 Series, United States)
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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.
|
Plasma vanadium concentrations were measured using inductively coupled plasma mass spectrometry (ICP-MS) (Agilent 7700 Series, United States)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Gestational diabetes mellitus
Tidsram: From August 2012 to April 2015
|
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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From August 2012 to April 2015
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- XQL202202
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Kliniska prövningar på Graviditetsdiabetes
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Merck KGaA, Darmstadt, GermanyMerck Serono S.A.S., an affiliate of Merck KGaA, Darmstadt, GermanyAvslutadSmall Gestational Age (SGA)
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University of Colorado, DenverEunice Kennedy Shriver National Institute of Child Health and Human Development...Avslutad
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T.C. ORDU ÜNİVERSİTESİEge UniversityAvslutadGestational viktökningKalkon
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Milton S. Hershey Medical CenterIndragen
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University of HawaiiAvslutadGestational viktökningFörenta staterna
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Helena PiccininiNova Scotia Health AuthorityIndragenGestational viktökningKanada
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West China HospitalWest China Second University HospitalAvslutad
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Technical University of MadridAvslutad
Kliniska prövningar på Plasma vanadium concentration
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Istituto Clinico HumanitasOkändKnäartros | BroskdegenerationItalien