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

NCT04030611 | Unknown

• 1 other identifier: CMUH107-REC3--116
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Retinopathy

Keywords

Diabetic retinopathy, traditional Chinese medicine(TCM), Diagnositic tools, sensitivity, Blood stasis

Outcome Measures

Primary Outcomes (4)

• Automatic tongue diagnosis

  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.

  12 months

• body constitution questionnaire

  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.

  12 months

• Nailfold videocapillaroscopy (NVC)

  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.

  12 months

• pulse examinatin

  12 months

Study Arms (2)

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

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

Interventions

tongue diagnosis system DIAGNOSTIC_TEST

This study apply TCM diagnostic tools for clinical diseases, providing objective diagnostic data for evaluation to assess the association of blood stasis and DR.

Also known as: pulse wave analysis, body constitution questionnaires, nailfold capillaroscopy

control group; diabetic retinopahty group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants in this prospective cross-sectional study were recruited from the outpatient clinic of endocrinology in China Medical University Hospital, Taichung, Taiwan.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 40402, Taiwan

RECRUITING

MeSH Terms

Conditions

Diabetic Retinopathy; Hypersensitivity

Interventions

Pulse Wave Analysis; Microscopic Angioscopy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Intravital Microscopy; Microscopy; Diagnostic Imaging; Investigative Techniques

Central Study Contacts

Po-Chi Hsu, MD. PhD

CONTACT

+88622053366; bryanhsu0813@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 24, 2019
• Study Start: January 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: October 10, 2019
• Last Updated: July 24, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)