The Sensitivity of Traditional Chinese Medical Diagnostic Tools for Diabetic Retinopathy Diabetic retinopathy-a Pilot Study

• Sponsor: China Medical University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04030611
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 9.3
• Patients Per Site Per Month: 10.8

Study Details

Study Description

Brief Summary

Diabetic retinopathy (DR) is the leading cause of impaired visual function and blindness in adults. The fundus photographs were examined to detect DR. The DR severity was graded non-proliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR) according to the International Clinical Diabetic Retinopathy and Diabetic Macular Edema Disease Severity Scales. The pathogenesis of DR is complex and not fully understood, and platelet aggregation, microvascular damage, microvascular enlargement, leakage, hemorrhage, or obstruction, resulting in retinal hypoxia and retinal neovascularization. Traditional Chinese medicine (TCM) diagnostic tools are non-invasive and convenient. This study apply TCM diagnostic tools for clinical diseases, providing objective diagnostic data for evaluation to assess the association of blood stasis and DR. Furtherly we would evaluate the sensitivity and specificity of TCM diagnostic tools.

This study is a prospective cross-sectional study. We enroll participants form the department of Chinese medicine, China Medical University Hospital. In total, 100 participants , composed of 50 of type 2 diabetes and 50 of diabetic retinopathy, whom previously had a retinal examination. We apply tongue diagnosis system, pulse wave analysis, body constitution questionnaires, and nailfold capillaroscopy to assess the differences of TCM diagnosis in DR.

This study aims to identify the clinical symptoms of DR with TCM diagnostic tools and investigate the pattern difference and treatment for DR. Furtherly, we could design a clinical trial with improving blood circulation to treat or prevent DR, and improve the health status and quality of life in patients with type 2 diabetes.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy	Diagnostic Test: tongue diagnosis system

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Assessment the Sensitivity of Traditional Chinese Medical Diagnostic Tools for Diabetic retinopathy-a Pilot Study
• Actual Study Start Date: Jan 1, 2019
• Anticipated Primary Completion Date: Sep 1, 2019
• Anticipated Study Completion Date: Oct 10, 2019

Arms and Interventions

Arm	Intervention/Treatment
control group Participants in the type 2 DM group were diagnosed with DM based on criteria recommended by the American Diabetes Association and required to have a fasting plasma glucose of ≥7mmol/L or an HbA1c of ≥6.5%, as measured on 2 separate occasions.	Diagnostic Test: tongue diagnosis system; This study apply TCM diagnostic tools for clinical diseases, providing objective diagnostic data for evaluation to assess the association of blood stasis and DR.; Other Names: pulse wave analysis body constitution questionnaires nailfold capillaroscopy
diabetic retinopahty group Participants in th ediabetic retinopahty group group were diagnosed according to the International Clinical Diabetic Retinopathy and Diabetic Macular Edema Disease Severity Scales.	Diagnostic Test: tongue diagnosis system; This study apply TCM diagnostic tools for clinical diseases, providing objective diagnostic data for evaluation to assess the association of blood stasis and DR.; Other Names: pulse wave analysis body constitution questionnaires nailfold capillaroscopy

Outcome Measures

Primary Outcome Measures

1. Automatic tongue diagnosis [12 months]

   We observe the tongue features of blood stasis, such as bluish tongue, petechiae, and engorged sublingual vessels, and compare the relationship between diabetic retinopathy and blood stasis.

2. body constitution questionnaire [12 months]

   We observe the body constitution questionnaires, such as yi deficiency, yang deficiency and phlegm-stasis, and compare the relationship between diabetic retinopathy and blood stasis.

3. Nailfold videocapillaroscopy (NVC) [12 months]

   We evaluate the capillary density, length, morphology, distribution, presence of enlarged loops or hemorrhages, and blood flow. NVC score was used to quantitate the aforementioned characteristics.

4. pulse examinatin [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• type 2 DM group were diagnosed with DM based on criteria recommended by the American Diabetes Association and required to have a fasting plasma glucose of ≥7mmol/L or an HbA1c of ≥6.5%, as measured on 2 separate occasions.

Exclusion Criteria:

• cancer, active liver disease, current pregnancy, active infection, and cerebrovascular disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	China Medical University Hospital	Taichung		Taiwan	40402

Sponsors and Collaborators

• China Medical University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: China Medical University Hospital
• ClinicalTrials.gov Identifier: NCT04030611
• Other Study ID Numbers: CMUH107-REC3--116
• First Posted: Jul 24, 2019
• Last Update Posted: Jul 24, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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 retinopathy, traditional Chinese medicine(TCM), Diagnositic tools, sensitivity, Blood stasis
• Additional relevant MeSH terms: Retinal Diseases; Diabetic Retinopathy; Hypersensitivity

Study Results

No Results Posted as of Jul 24, 2019