NCT02564913

Brief Summary

In traditional Chinese medicine (TCM), examination of the tongue plays an important role in diagnosis. The characteristics of the tongue(e.g., color of the tongue body, tongue fur, teeth-marked tongue) provides some clues and prognosis, which are considered a reflection of the body's internal condition. Diabetes mellitus is a metabolic disorder of hyperglycemia, which lead to damage the kidneys, eyes, nerves, blood vessels, and heart. Long standing hyperglycemia can also be associated with buccal alteration. The purpose of this study was to survey on tongue diagnosis and other examinations associated with diabetic mellitus.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2011

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2015

Completed
Last Updated

October 1, 2015

Status Verified

September 1, 2015

Enrollment Period

2.9 years

First QC Date

September 29, 2015

Last Update Submit

September 29, 2015

Conditions

Diabetes Mellitus

Keywords

tongue diagnosisheart rate variabilitynailfold videocapillaroscopy

Outcome Measures

Primary Outcomes (3)

  • tongue diagnosis

    1 year

  • heart rate variability

    1 year

  • nailfold videocapillaroscopy

    1 year

Study Arms (3)

control group

Other: clinical evaluation

pre-DM group

Other: clinical evaluation

DM group

Interventions

clinical evaluationOTHER
control grouppre-DM group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The investigators recruited the control group , the pre-DM group, and the DM group.

You may qualify if:

  • diabetic patients(ac sugar\>126mg/dl or HbA1c\>6.5, twice)
  • pre-diabetic patients(100mg/dl \<ac sugar\<126mg/dl, or 5.9\<HbA1c\<6.5)
  • non-diabetic patients(ac sugar\<100mg/dl )

You may not qualify if:

  • acute infectious disease,
  • cancer,
  • End Stage Renal Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
traditional Chinese medical doctor

Study Record Dates

First Submitted

September 29, 2015

First Posted

October 1, 2015

Study Start

December 1, 2011

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

October 1, 2015

Record last verified: 2015-09