NCT05267457

Associations of Plasma Vanadium Concentrations With Gestational Diabetes Mellitus

Completed Last updated 18 March 2022

What this trial tests

trial testing Plasma vanadium concentration in Gestational Diabetes in 504 participants. Completed in 30 June 2020.

Timeline

1 August 2012

Primary endpoint
30 April 2015

30 June 2020

Quick facts

Lead sponsor	Liegang Liu
Status	Completed
Study type	OBSERVATIONAL
Enrollment	504
Start date	1 August 2012
Primary completion	30 April 2015
Estimated completion	30 June 2020

Drugs / interventions tested

• Plasma vanadium concentration

Conditions studied

• Gestational Diabetes — all drugs for Gestational Diabetes →

Sponsor

Liegang Liu

Who can join

Adults 20 to 43, female only, with Gestational Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Inverse Association of Plasma Vanadium Concentrations with Gestational Diabetes Mellitus.
   Li X, Zhu Y, Yin J, Li B, et al · · 2022 · cited 6× · PMID 35406027 · DOI 10.3390/nu14071415