Association Between TMAO and Diabetes

Type2 Diabetes Clinical Trial

Official title:

Association Between Microbiota-dependent Metabolite Trimethylamine-N-oxide and Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03130894
• Other study ID #: 2012BAI02B02
• Status: Completed
• Phase: N/A
• First received: April 24, 2017
• Last updated: April 25, 2017
• Start date: January 1, 2012
• Est. completion date: June 30, 2016

Study information

• Verified date: April 2017
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2694
• Est. completion date: June 30, 2016
• Est. primary completion date: December 30, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Other:
• Plasma TMAO concentration
Plasma TMAO concentration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Liegang Liu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	type 2 diabetes	odd ratio (OR) for type 2 diabetes	through recruitment completion, an average of 3 years