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Tongue Fur and Metabolites in Diabetes Mellitus

Primary Purpose

Diabetes Mellitus, Pre-diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Liquid chromatography-mass spectrometry (LC-MS) analysis
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetes Mellitus focused on measuring diabetic mellitus , tongue fur, metabolites, and biomarkers

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • China Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

To establish metabolite pattern and biomarkers of tongue fur in DM

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 22, 2021
Last Updated
May 26, 2021
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04909632
Brief Title
Tongue Fur and Metabolites in Diabetes Mellitus
Official Title
Correlation Between Tongue Fur and Metabolites in Diabetes Mellitus and pre-diabetes-a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Pre-diabetes
Keywords
diabetic mellitus , tongue fur, metabolites, and biomarkers

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
To establish metabolite pattern and biomarkers of tongue fur in DM
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Liquid chromatography-mass spectrometry (LC-MS) analysis
Intervention Description
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 Measure Information:
Title
The differentiation of tongue features mellitus and pre-diabetes
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
The tongue coating metabolic markers in patients with diabetes
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of type 2 DM Clinical diagnosis of pre-DM Participants in the control group had a normal fasting glucose level Exclusion Criteria: comorbidity of inadequate heart, liver, kidney, or other serious diseases. pregnancy or lactation. history of mental illness.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Po-Chi Hsu
Phone
04-22053366
Ext
3123
Email
bryanhsu0813@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lun-Chien Lo
Organizational Affiliation
China Medical University, China
Official's Role
Study Director
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40402
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Po-Chi Hsu, MD. PhD
Email
bryanhsu0813@gmail.com

12. IPD Sharing Statement

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Tongue Fur and Metabolites in Diabetes Mellitus

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