Type2 Diabetes Clinical Trial
Official title:
Association Between Microbiota-dependent Metabolite Trimethylamine-N-oxide and Type 2 Diabetes
Background: The association of trimethylamine-N-oxide (TMAO), a microbiota dependent
metabolite from dietary choline and carnitine, with type 2 diabetes was inconsistent.
Objective: The investigators planned to investigate the association between plasma TMAO and
newly diagnosed type 2 diabetes as well as whether the association could be modified by the
TMAO-generating enzyme flavin monooxygenase 3 (FMO3) polymorphisms.
Design: This is an age- and sex-matched case-control study of 2694 participants: 1346 newly
diagnosed cases of type 2 diabetes and 1348 controls. The patients of newly diagnosed type 2
diabetes were consecutively recruited from those attending for the first time the outpatient
clinics of Department of Endocrinology, Tongji Medical College Hospital, Wuhan, China, from
2012 January to December 2014. Concomitantly, the investigators recruited healthy
individuals who were frequency-matched by age (±5 years) and sex to patients from an
unselected population undergoing a routine health check-up in the same hospital. The
inclusion criteria for controls and newly diagnosed type 2 diabetes were: age ≥ 30 years,
body mass index (BMI) < 40 kg/m2, no history of a diagnosis of diabetes and no history of
receiving pharmacological treatment for hyperlipidaemia or hypertension. Patients with
clinically significant neurological, endocrinological or other systemic diseases, as well as
acute illness or chronic inflammatory or infective diseases, were excluded from the study.
All the participants enrolled were of Chinese Han ethnicity. All the participants gave
informed written consent to the study and did not take any medication known to affect
glucose tolerance or insulin secretion before participation. The study was approved by the
ethics committee of the Tongji Medical College. Concentrations of plasma TMAO were measured,
and FMO3 E158K polymorphism (rs2266782) were genotyped.
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