Type2 DiabetesNCT03130894
Association Between TMAO and Diabetes
An observational study of Type2 Diabetes, run by Liegang Liu.
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… Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Plasma TMAO concentration
- Type of treatment
- Pill or oral medicine
- How many people
- 2,694 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 30 Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Association Between Microbiota-dependent Metabolite Trimethylamine-N-oxide and Type 2 Diabetes
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
- Being tested
- Plasma TMAO concentration
- Keywords
- trimethylamine-N-oxide, type2 Diabetes, enzyme flavin monooxygenase 3 polymorphisms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma TMAO concentrationOther
Plasma TMAO concentration
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Plasma TMAO concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
type 2 diabetes
odd ratio (OR) for type 2 diabetes
Measured: through recruitment completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start1 Jan 2012
- Primary completion30 Dec 2014
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 2,694 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liegang Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liegang Liu, Huazhong University of Science and Technology
- Investigators
- Liegang Liu, PhD, Study director, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130894
- Sponsor's protocol ID
- 2012BAI02B02
- Status last verified
- Apr 2017
- First submitted
- 24 Apr 2017
- Last updated
- 27 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28724646
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Microbiota-dependent Metabolite Trimethylamine-N-oxide and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03130894
- Acronym / sponsor ID
- 2012BAI02B02
- Conditions
- Type2 Diabetes
- Keywords
- trimethylamine-N-oxide, type2 Diabetes, enzyme flavin monooxygenase 3 polymorphisms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,694 participants (actual)
- Lead sponsor
- Liegang LiuUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 30 Dec 2014 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 27 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy control | – | Other: Plasma TMAO concentrationA 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. |
| Type 2 diabetes | – | Other: Plasma TMAO concentrationType 2 diabetes was diagnosed when fasting plasma glucose (FPG) ≥ 7.0 mmol/l, and/or 2-h post-glucose load ≥ 11.1 mmol/l. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma TMAO concentrationPlasma TMAO concentration | Other | Healthy control, Type 2 diabetes |
Primary outcome
type 2 diabetes
Time frame: through recruitment completion, an average of 3 years
odd ratio (OR) for type 2 diabetes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Derived from this study: PubMed 28724646Shan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liegang Liu, PhD study director
Huazhong University of Science and Technology
Questions about this trial
What is this clinical trial studying?
An observational study of Type2 Diabetes, run by Liegang Liu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
type 2 diabetes (time frame: through recruitment completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03130894, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.