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Tongue Fur and Metabolites in Diabetes Mellitus

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04909632
Recruitment Status : Recruiting
First Posted : June 2, 2021
Last Update Posted : June 2, 2021
Information provided by (Responsible Party):
China Medical University Hospital

Brief 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, 400 participants , composed of 100 of type 2 diabetes , 100 of pre-DM and 200 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Pre-diabetes Diagnostic Test: Liquid chromatography-mass spectrometry (LC-MS) analysis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Correlation Between Tongue Fur and Metabolites in Diabetes Mellitus and pre-diabetes-a Pilot Study
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
Experimental: To establish metabolite pattern and biomarkers of tongue fur in DM Diagnostic Test: Liquid chromatography-mass spectrometry (LC-MS) analysis
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. The tongue coating metabolic markers in patients with diabetes [ Time Frame: 2 years ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Clinical diagnosis of type 2 DM
  2. Clinical diagnosis of pre-DM
  3. Participants in the control group had a normal fasting glucose level

Exclusion Criteria:

  1. comorbidity of inadequate heart, liver, kidney, or other serious diseases.
  2. pregnancy or lactation.
  3. history of mental illness.

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 identifier (NCT number): NCT04909632

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Contact: Po-Chi Hsu 04-22053366 ext 3123

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China Medical University Hospital Recruiting
Taichung, Taiwan, 40402
Contact: Po-Chi Hsu, MD. PhD   
Sponsors and Collaborators
China Medical University Hospital
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Study Director: Lun-Chien Lo China Medical University, China
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Responsible Party: China Medical University Hospital Identifier: NCT04909632    
Other Study ID Numbers: CMUH109-REC1-138
First Posted: June 2, 2021    Key Record Dates
Last Update Posted: June 2, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by China Medical University Hospital:
diabetic mellitus , tongue fur, metabolites, and biomarkers
Additional relevant MeSH terms:
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Diabetes Mellitus
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases