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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes
• Intervention / Treatment: Other: Plasma vanadium concentration

• Study Type: Observational
• Enrollment (Actual): 504

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 43 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

All the participants enrolled were Chinese women. They gave informed written consent to the study and did not take any medication known to affect glucose tolerance or insulin secretion before participation.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Gestational diabetes mellitus; Gestational diabetes mellitus (GDM) was diagnosed according to the American Diabetes Association criteria, which is based on the "one-step" approach recommended by the International Association of Diabetes and Pregnancy Study Groups. All women underwent a 75g OGTT in the morning after an overnight fast, with plasma glucose measurement fasting and at 1 and 2 hours. The criteria for GDM diagnosis was to have at least one abnormal value: Fasting glucose ≥ 5.1 mmol/L (92 mg/dL), 1 h glucose ≥ 10.0 mmol/L (180 mg/dL), 2 h glucose ≥ 8.5 mmol/L (153 mg/dL).	Other: Plasma vanadium concentration; Plasma vanadium concentrations were measured using inductively coupled plasma mass spectrometry (ICP-MS) (Agilent 7700 Series, United States)
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.	Other: Plasma vanadium concentration; Plasma vanadium concentrations were measured using inductively coupled plasma mass spectrometry (ICP-MS) (Agilent 7700 Series, United States)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Liegang Liu

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2012
• Primary Completion (Actual): April 30, 2015
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Gestational diabetes mellitus; Vanadium
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Diabetes, Gestational; Physiological Effects of Drugs; Trace Elements; Micronutrients; Vanadium
• Other Study ID Numbers: XQL202202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No