Optimization and Evaluation of the Diagnosis and Treatment System for Diabetic Retinopathy in Type 2 Diabetes Mellitus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fundus Examination, Metabolomics analysis.
- Who it may be relevant to
- Registry conditions: Diabetes, Diabetic Retinopathy, Type 2 Diabetes Mellitus (T2DM). Basic parameters: 20 years — 79 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study aims to integrate clinical indicators and features of fundus images, combined with metabolomics, to construct an early warning model for diabetic retinopathy (DR) in type 2 diabetes. By combining clinical indicators with metabolomics, the investigators aim to establish a precise DR typing model based on the age of diabetes onset (early-onset diabetes, late-onset diabetes) and based on the coexistence with two types of diabetic macrovascular complications. A multidisciplinary collaboration will be conducted for comprehensive management of DR to control the progression of moderate-stage DR. Cloud-based patient rooms combined with continuous glucose monitoring (CGM) will further explore the role of integrated diabetes retinopathy ward management models in the management of patients undergoing diabetes retinopathy surgery, pioneering a new model for the management of advanced DR.
Interventions
- Diagnostic test Fundus Examination
Performing fundus photography on patients to assess the progression of diabetic retinopathy (DR). - Diagnostic test Metabolomics analysis
Conduct metabolomics testing at enrollment.
Primary outcome measures
- Fundus examination [Time frame: Conduct examinations at enrollment and twelve months after enrollment.]
Secondary outcome measures (5)
- Metabolomics analysis [Time frame: at enrollment]
- Triglycerides [Time frame: Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.]
- Glycated Hemoglobin [Time frame: Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.]
- Insulin levels [Time frame: Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.]
- Total Cholesterol [Time frame: Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.]
Eligibility criteria
Inclusion criteria
- Meets the diagnostic criteria for type 2 diabetes in the "China Type 2 Diabetes Prevention and Treatment Guidelines (2020 Edition)";
- Aged between 20 and 79 years old, without other severe underlying diseases; ③ Possesses full cognitive and literacy abilities; ④ Volunteers to participate in this study and are willing to sign an informed consent form.
Exclusion criteria
- Those who have been diagnosed with type 1 or other types of diabetes;
- Those with severe cardiac, pulmonary, hepatic, or renal insufficiency;
- Those with mental confusion, speech disorders, or dementia, etc.;
- Those who are unable to take care of themselves, bedridden, or have mobility impairments; ⑤ Women who are breastfeeding or pregnant;
- Those with a recent history of surgery, trauma, acute major vascular complications, or infectious diseases.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 3 centers
- The first hosptial of lanzhou university — Lanzhou
- Shanghai general hosptial — Shanghai
- The forth people's hosptial of shenyang — Shenyang
Identifiers
NCT: NCT06821399 · 2023ZD0508104