Associations of Plasma Vanadium Concentrations With Gestational Diabetes Mellitus

Gestational Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05267457
• Other study ID #: XQL202202
• Status: Completed
• Start date: August 1, 2012
• Est. completion date: June 30, 2020

Study information

• Verified date: March 2022
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 504
• Est. completion date: June 30, 2020
• Est. primary completion date: April 30, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 43 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Intervention

Other:
• Plasma vanadium concentration
Plasma vanadium concentrations were measured using inductively coupled plasma mass spectrometry (ICP-MS) (Agilent 7700 Series, United States)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Liegang Liu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational diabetes mellitus	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.	From August 2012 to April 2015