Association Between TMAO and Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2694 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-01

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Assessment of Metabolic Profiles of Lower Extremity Arterial Disease in Patiens Withe Type 2 Diabetes

NCT05068895

Diabetic Angiopathies Diabetes Mellitus, Type 2

UNKNOWN

Molecular and Clinical Profile of Diabetes Mellitus and Its Complications

NCT01105858

Diabetes Mellitus, Type 2 Diabetic Nephropathy Obesity

SUSPENDED

Early Changes in Pulmonary Function and Vascular Endothelial Function and the Correlation Between Them in T2DM Patients

NCT03575988

Diabetes Mellitus, Type 2

UNKNOWN

Arginase Inhibition and Microvascular Endothelial Function in Type 2 Diabetes

NCT02687152

Type 2 Diabetes Mellitus

COMPLETED PHASE1/PHASE2

Seum Bile Acid Profile in Type 2 Diabetes and Association Between Bile Cid Profile and Adipokine or Oxidative Stress

NCT02650830

Type 2 Diabetes Prediabetes Non-alcoholic Fatty Liver Disease +1 more

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Plasma TMAO concentration

Intervention Type 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.

Plasma TMAO concentration

Intervention Type OTHER

Plasma TMAO concentration

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Plasma TMAO concentration

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes