Ignite Creation Date:
2024-05-06 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03130894
Status:
COMPLETED
Last Update Posted:
2017-04-27
First Post:
2017-04-24
Brief Title:
Association Between TMAO and Diabetes
Sponsor:
Liegang Liu
Organization:
Huazhong University of Science and Technology
Study Overview
Official Title:
Association Between Microbiota-dependent Metabolite Trimethylamine-N-oxide and Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 kgm2 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
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 kgm2 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None