Association Between TMAO and Diabetes

NCT03130894 | Completed

• 1 other identifier: 2012BAI02B02
• Study Type: observational
• Target: 2,694
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type2 Diabetes

Keywords

trimethylamine-N-oxide; type2 Diabetes; enzyme flavin monooxygenase 3 polymorphisms

Outcome Measures

Primary Outcomes (1)

• type 2 diabetes

  odd ratio (OR) for type 2 diabetes

  through recruitment completion, an average of 3 years

Study Arms (2)

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

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

Interventions

Plasma TMAO concentration OTHER

Plasma TMAO concentration

Healthy control; Type 2 diabetes

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liegang Liu: lead

Related Publications (1)

• Shan Z, Sun T, Huang H, Chen S, Chen L, Luo C, Yang W, Yang X, Yao P, Cheng J, Hu FB, Liu L. Association between microbiota-dependent metabolite trimethylamine-N-oxide and type 2 diabetes. Am J Clin Nutr. 2017 Sep;106(3):888-894. doi: 10.3945/ajcn.117.157107. Epub 2017 Jul 19.

  PMID: 28724646 DERIVED

Study Officials

• Liegang Liu, PhD

  Huazhong University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: April 27, 2017
• Study Start: January 1, 2012
• Primary Completion: December 30, 2014
• Study Completion: June 30, 2016
• Last Updated: April 27, 2017

Record last verified: 2017-04