We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 11 of 7520 for:    Type 2 Diabetes

Association Between TMAO and Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03130894
Recruitment Status : Completed
First Posted : April 27, 2017
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):

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
Type2 Diabetes 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 : January 1, 2012
Primary Completion Date : December 30, 2014
Study Completion Date : June 30, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort 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 [ Time Frame: through recruitment completion, an average of 3 years ]
    odd ratio (OR) for type 2 diabetes


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03130894


Sponsors and Collaborators
Liegang Liu
Investigators
Study Director: Liegang Liu, PhD Huazhong University of Science and Technology
More Information

Responsible Party: Liegang Liu, Professor, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT03130894     History of Changes
Other Study ID Numbers: 2012BAI02B02
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Liegang Liu, Huazhong University of Science and Technology:
trimethylamine-N-oxide
type2 Diabetes
enzyme flavin monooxygenase 3 polymorphisms

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases