Diabetes MellitusNCT04909632
Tongue Fur and Metabolites in Diabetes Mellitus
A study testing Liquid chromatography-mass spectrometry (LC-MS) analysis in people with Diabetes Mellitus and Pre-diabetes, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
This study is a prospective cross-sectional study. The investigators enroll participants form the department of endocrinology and of metabolism, China Medical University Hospital. In total, 300 participants , composed of 100 of type 2 diabetes , 100 of pre-DM and 100 healthy participants. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Pre-diabetes
- What is being tested?
- Liquid chromatography-mass spectrometry (LC-MS) analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2020to 31 Jul 2022
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of type 2 DM
- Clinical diagnosis of pre-DM
- Participants in the control group had a normal fasting glucose level
Who cannot join
- comorbidity of inadequate heart, liver, kidney, or other serious diseases.
- pregnancy or lactation.
- history of mental illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Tongue Fur and Metabolites in Diabetes Mellitus and pre-diabetes-a Pilot Study
This study is a prospective cross-sectional study. The investigators enroll participants form the department of endocrinology and of metabolism, China Medical University Hospital. In total, 300 participants , composed of 100 of type 2 diabetes , 100 of pre-DM and 100 healthy participants. The investigators apply tongue diagnosis system, pulse wave analysis, body constitution questionnaires, and nailfold capillaroscopy to assess the differences of TCM diagnosis. After collecting the tongue coating and analyzing the metabolite signals with a flying mass spectrometer, The investigators collect the data to establish metabolite pattern and biomarkers.
This study aims to identify the clinical symptoms of DM with TCM diagnostic tools and investigate the pattern difference and treatment for DM. Furtherly, the investigators add mass spectrometer to analyze the metabolites of tongue coating, the investigators propose to establish a metabolite pattern and biomarker to identify important biological indicators of DM.
- Conditions
- Diabetes Mellitus, Pre-diabetes
- Being tested
- Liquid chromatography-mass spectrometry (LC-MS) analysis
- Keywords
- diabetic mellitus , tongue fur, metabolites, and biomarkers
- Medical subject headings
- Diabetes Mellitus, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid chromatography-mass spectrometry (LC-MS) analysisDiagnostic test
The data were acquired by UNIFI software (Waters) and processed by UNIFI and Progenesis QI software. Omics analysis methods, such as principal component analysis (PCA), partial least squares-discriminate analysis (PLS-DA), and orthogonal partial least squares-discriminate analysis (OPLS-DA), were employed to identify the biochemical patterns in tongue coating samples and suggest variables that can be used as biomarkers for diabetes and pre-diabetes.
| Study group | Role | What they receive |
|---|---|---|
| To establish metabolite pattern and biomarkers of tongue fur in DM | Experimental | Not described Receives: Diagnostic Test: Liquid chromatography-mass spectrometry (LC-MS) analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The differentiation of tongue features mellitus and pre-diabetes
The primary outcome is the differentiation of tongue features extracted by ATDS. There are nine primary features for TCM clinical tongue diagnosis, namely, tongue shape, tongue color, fur thickness, fur color, saliva, tongue fissure, ecchymosis, teeth mark, and red dot. Features identified are further sub-divided according to the areas located, i.e., heart-lung area, left liver-gall, right liver-gall, spleen-stomach, and kidney.
Measured: 2 years
Secondary outcomes (1)
The tongue coating metabolic markers in patients with diabetes
The study researched tongue coating metabolic markers in patients with diabetes to determine any relationship between tongue diagnosis and metabolic processes. Chromatographic analysis and comparison between the diabetes group and normal controls. PCA and PLS-DA analysis of metabolic profiles of tongue coating samples from the chronic gastritis group and normal controls. To improve the accuracy of the PLS discriminated model, OPLS-DA was used to analysis the results by removing some redundant information, such as envir- onmental factors, gender, and diet. Tongue metabolic fingerprint differences between the chronic gastritis group and normal controls were compared using OPLS-DA.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start1 Mar 2020
- Primary completion31 Dec 2021
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lun-Chien Lo, Study director, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909632
- Sponsor's protocol ID
- CMUH109-REC1-138
- Status last verified
- Mar 2025
- First submitted
- 22 May 2021
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Tongue Fur and Metabolites in Diabetes Mellitus and pre-diabetes-a Pilot Study
- ClinicalTrials.gov ID
- NCT04909632
- Acronym / sponsor ID
- CMUH109-REC1-138
- Conditions
- Diabetes Mellitus, Pre-diabetes
- Keywords
- diabetic mellitus , tongue fur, metabolites, and biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 2 Jun 2021 (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.
This study is a prospective cross-sectional study. The investigators enroll participants form the department of endocrinology and of metabolism, China Medical University Hospital. In total, 300 participants , composed of 100 of type 2 diabetes , 100 of pre-DM and 100 healthy participants. The investigators apply tongue diagnosis system, pulse wave analysis, body constitution questionnaires, and nailfold capillaroscopy to assess the differences of TCM diagnosis. After collecting the tongue coating and analyzing the metabolite signals with a flying mass spectrometer, The investigators collect the data to establish metabolite pattern and biomarkers.
This study aims to identify the clinical symptoms of DM with TCM diagnostic tools and investigate the pattern difference and treatment for DM. Furtherly, the investigators add mass spectrometer to analyze the metabolites of tongue coating, the investigators propose to establish a metabolite pattern and biomarker to identify important biological indicators of DM.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| To establish metabolite pattern and biomarkers of tongue fur in DM | Experimental | Diagnostic Test: Liquid chromatography-mass spectrometry (LC-MS) analysis |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of type 2 DM
- Clinical diagnosis of pre-DM
- Participants in the control group had a normal fasting glucose level
Key exclusion criteria (3 listed)
- comorbidity of inadequate heart, liver, kidney, or other serious diseases.
- pregnancy or lactation.
- history of mental illness.
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 |
|---|---|---|
| Liquid chromatography-mass spectrometry (LC-MS) analysisThe data were acquired by UNIFI software (Waters) and processed by UNIFI and Progenesis QI software. Omics analysis methods, such as principal component analysis (PCA), partial least squares-discriminate analysis (PLS-DA), and orthogonal partial least squares-discriminate analysis (OPLS-DA), were employed to identify the biochemical patterns in tongue coating samples and suggest variables that can be used as biomarkers for diabetes and pre-diabetes. | Diagnostic test | To establish metabolite pattern and biomarkers of tongue fur in DM |
Primary outcome
The differentiation of tongue features mellitus and pre-diabetes
Time frame: 2 years
The primary outcome is the differentiation of tongue features extracted by ATDS. There are nine primary features for TCM clinical tongue diagnosis, namely, tongue shape, tongue color, fur thickness, fur color, saliva, tongue fissure, ecchymosis, teeth mark, and red dot. Features identified are further sub-divided according to the areas located, i.e., heart-lung area, left liver-gall, right liver-gall, spleen-stomach, and kidney.
1 secondary outcome
The tongue coating metabolic markers in patients with diabetes
Time frame: 2 years
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 3 Apr 2025.
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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.
Lun-Chien Lo study director
China Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liquid chromatography-mass spectrometry (LC-MS) analysis in people with Diabetes Mellitus and Pre-diabetes, run by China Medical University Hospital at 1 site in Taiwan.
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 3 inclusion and 3 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 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The differentiation of tongue features mellitus and pre-diabetes (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2025.