Tongue Fur and Metabolites in Diabetes Mellitus

China Medical University

Status: Completed

Conditions: Pre-diabetes; Diabetes Mellitus

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04909632

CMUH109-REC1-138

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 1 patient group

To establish metabolite pattern and biomarkers of tongue fur in DM

Experimental group

Treatment:

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