Multicenter RCT of Eye-Brain Imaging in Diabetes Neurovascular Coupling

Launched by HEJIANG YE · Feb 3, 2025

Keywords

ClinConnect Summary

This clinical trial is focused on understanding and improving the health of people with diabetes, particularly those experiencing issues with their eyes and brain. Researchers will use advanced imaging technology to study how diabetes affects connections between the eyes and brain, aiming to create better ways to diagnose and treat related conditions like diabetic retinopathy (eye damage) and cognitive impairment (problems with thinking and memory). They will also evaluate the effectiveness of a Traditional Chinese Medicine treatment called Tangshen'an Granule in helping prevent and treat these complications.

To participate in this study, individuals must be between 18 and 70 years old and diagnosed with diabetes and specific types of neurovascular issues related to it. They should also have a certain level of blood sugar control, as indicated by a test called HbA1c. Participants will undergo assessments and may receive the treatment or a placebo (a substance with no active treatment) in a controlled environment, meaning neither they nor the researchers will know who is receiving what. This trial aims to gather solid evidence to enhance diabetes care and explore new treatment options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants who comply with the diagnostic criteria for DM according to the World Health Organization in 1999.
• • Participants who fulfill the diagnostic criteria for diabetic NCI.
• • ③ Participants who diagnosed with the syndrome of kidney deficiency and blood stasis according to TCM syndrome differentiation.
• • ④ Participants who have a glycated hemoglobin(HbA1c) level of ≤9%.
• • ⑤ Participants who are aged between 18 and 70 years inclusive, with no gender preference.
• • ⑥Participants who sign informed consent form.
• Exclusion Criteria:
• • Participants exhibiting retinopathy induced by alternative etiological factors (including retinal vein occlusion, age-related macular degeneration(AMD), alongside cognitive impairments stemming from endocrine-metabolic disturbances, sleep disorders.
• • Participants suffering from acute diabetic complications (such as diabetic ketoacidosis, hyperosmolar hyperglycemic state).
• • Participants with significant dysfunction in the heart, liver, kidney, or autoimmune disorders.
• • ④Participants unable to cooperate due to mental health issues, intellectual disabilities, or similar conditions that impede their participation in the trial.
• • ⑤Participants who are allergic to the intervention used in this study.
• • ⑥Participants who have engaged in other trials within the past three months or are currently enrolled in another study.
• • ⑦Female participants who are in the process of trying to conceive, are pregnant, or are lactating.