Association Between TMAO and Diabetes

Sponsor
Liegang Liu (Other)
Overall Status
Completed
CT.gov ID
NCT03130894
Collaborator
(none)
2,694
53.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Plasma TMAO concentration

Study Design

Study Type:
Observational
Actual Enrollment :
2694 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Association Between Microbiota-dependent Metabolite Trimethylamine-N-oxide and Type 2 Diabetes
Actual Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Dec 30, 2014
Actual Study Completion Date :
Jun 30, 2016

Arms and Interventions

Arm Intervention/Treatment
Healthy control

A FPG concentration < 6.1 mmol/l, and a 2-h oral glucose tolerance test (OGTT) plasma glucose concentration < 7.8 mmol/l was considered normal glucose tolerance.

Other: Plasma TMAO concentration
Plasma TMAO concentration

Type 2 diabetes

Type 2 diabetes was diagnosed when fasting plasma glucose (FPG) ≥ 7.0 mmol/l, and/or 2-h post-glucose load ≥ 11.1 mmol/l.

Other: Plasma TMAO concentration
Plasma TMAO concentration

Outcome Measures

Primary Outcome Measures

  1. type 2 diabetes [through recruitment completion, an average of 3 years]

    odd ratio (OR) for type 2 diabetes

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Concomitantly, we 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.

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Liegang Liu

Investigators

  • Study Director: Liegang Liu, PhD, Huazhong University of Science and Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Liegang Liu, Professor, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT03130894
Other Study ID Numbers:
  • 2012BAI02B02
First Posted:
Apr 27, 2017
Last Update Posted:
Apr 27, 2017
Last Verified:
Apr 1, 2017
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Liegang Liu, Professor, Huazhong University of Science and Technology
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2017