Tongue Fur and Metabolites in Diabetes Mellitus

NCT04909632 | Completed

• 1 other identifier: CMUH109-REC1-138
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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, 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

Keywords

diabetic mellitus , tongue fur, metabolites, and biomarkers

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (1)

• The tongue coating metabolic markers in patients with diabetes

  2 years

Study Arms (1)

To establish metabolite pattern and biomarkers of tongue fur in DM

EXPERIMENTAL

Diagnostic Test: Liquid chromatography-mass spectrometry (LC-MS) analysis

Interventions

Liquid chromatography-mass spectrometry (LC-MS) analysis DIAGNOSTIC_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.

To establish metabolite pattern and biomarkers of tongue fur in DM

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 40402, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus; Glucose Intolerance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Study Officials

• Lun-Chien Lo

  China Medical University, China

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2021
• First Posted: June 2, 2021
• Study Start: March 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: July 31, 2022
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

TW (1)