Multicenter RCT of Eye-Brain Imaging in Diabetes Neurovascular Coupling
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: hypoglycemic treatment, Tangshen'an Granules, Ginkgo Leaf Tablets, Mecobalamin Tablets.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Diabetic Retinopathy, Cognitive Impairment, Neurovascular Coupling. Basic parameters: 18 years — 70 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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Official title
Multicenter, Double Blind, Randomized, Placebo-controlled Trial to Exploring the Role of Eye-Brain Multimodal Imaging in Diagnosing and Treating Neurovascular Coupling Impairment in Diabetes Mellitus
Overview
This study intends to take the critical pathological mechanism of diabetic neurovascular coupling injury (NCI) as the starting point and utilize multi-modal imaging (MMI) technology of the eyes and brain as a means to conduct in-depth, integrated, and interdisciplinary research with Traditional Chinese Medicine (TCM) syndrome studies. The aim is to establish diagnostic and therapeutic standards for diabetic NCI, based on Eye-Brain Multimodal Imaging technology, providing objective and quantitative evidence for early disease diagnosis and therapeutic effect evaluation. Simultaneously, investigators will conduct multicenter, randomized, placebo-controlled, double-blind clinical trials to systematically investigate the clinical efficacy and safety of Tangshen'an Granule in preventing and treating diabetic NCI. By obtaining high-quality evidence-based data on TCM, this study aims to enhance the level of prevention and treatment with TCM and clinical service capabilities, thereby providing new ideas and directions for research.
Detailed description
Diabetes mellitus(DM) is a prevalent condition that often leads to neurovascular coupling impairment (NCI), which has been shown to be intimately associated with diabetic retinopathy and cognitive decline. Given the critical need for early diagnosis and effective treatment, eye-brain multimodal imaging(MMI) technology has emerged as a promising tool in this field. This study focuses on establishing a comprehensive and standardized approach for diagnosing and treating diabetic NCI through the utilization of eye-brain MMI technology accompanied by assessing the effectiveness and potential therapeutic benefits of the traditional Chinese medicine compound, Tangshen'an Granule, in the management of diabetic NCI.
A pool of standard diagnostic and therapeutic entries for diabetic NCI syndromes using eye-brain MMI technology is planned to be established through database retrieval and refined by expert questionnaire surveys to formulate the relevant standards. A multicenter, randomized, double-blind, placebo-controlled clinical evaluation study of Tangshen'an Granules in treating diabetic NCI (kidney deficiency and blood stasis syndrome) patients from specific hospitals will be conducted. Diagnostic criteria involve diabetes diagnosis and specific requirements of multiple eye-brain imaging and cognitive assessment tools. Eligibility criteria include inclusion and exclusion conditions. Randomization and blinding are properly implemented. The intervention includes basic therapy with different drug administrations in the experimental and control groups. The trial lasts 24 weeks. Primary outcomes are evaluated by various eye-brain imaging and cognitive assessment means. Secondary outcomes involve TCM symptom scores, glycemic indicators, and quality of life questionnaire. Safety indicators are monitored. Data is analyzed using Intent-To-Treat (ITT) analysis.
The study protocol has been approved by the Ethics Committee of the Hospital of Chengdu University of Traditional Chinese Medicine(ethical approval number:2023KL-056). Informed consent is planned to be obtained from all participants. The study results will be reported in academic meetings and peer-reviewed journals to promote the development of diagnostic and treatment standards for diabetic NCI.
Interventions
- Drug hypoglycemic treatment
The diabetes management adheres to the "The 2025 Guidelines for Standards of Diabetes Care" issued by the American Diabetes Association (ADA). - Drug Tangshen'an Granules
Tangshen'an Granules comprises a meticulously blended mix of Astragalus, Prepared Rehmannia Root, Dodder Seed, Kudzu Root, Millettia Speciosa Champ, Salviae Miltiorrhizae Radix et Rhizoma, Poria Cocos, and Polygala Tenuifolia. Tangshen'an Granules is administered at a dosage of 9g, dissolved in boiling water, and taken three times daily. - Drug Ginkgo Leaf Tablets
The primary active ingredients of Ginkgo Leaf Tablets are ginkgo flavonoid glycosides and terpene lactones. The prescribed oral dosage is one tablet each time, administered three times a day. - Drug Mecobalamin Tablets
Mecobalamin Tablets primarily contain mecobalamin, which is a coenzyme-active form of vitamin B12. The prescribed oral dosage is 0.5mg, administered three times a day. - Drug placebo
The placebo contains 10% of the active ingredients in Tangshen'an Granules, formulated by controlling the concentration to mimic Tangshen'an Granules. The placebo is administered at a dosage of 9g, dissolved in boiling water, and taken three times daily.
Primary outcome measures
- Retinal Nerve Fiber Layer Thickness (RNFL) [Time frame: From the date of randomization until the end of the 24-week intervention period]
- Foveal Avascular Zone (FAZ) [Time frame: From the date of randomization until the end of the 24-week intervention period]
- Visual Evoked Potential (VEP) [Time frame: From the date of randomization until the end of the 24-week intervention period]
- Gray matter volume (GMV) [Time frame: From the date of randomization until the end of the 24-week intervention period]
- Montreal Cognitive Assessment（MoCA）score [Time frame: From the date of randomization until the end of the 24-week intervention period]
- Mini - Mental State Examination（MMSE）score [Time frame: From the date of randomization until the end of the 24-week intervention period]
Secondary outcome measures (4)
- Symptom scores in traditional Chinese medicine [Time frame: From the date of randomization until the end of the 24-week intervention period]
- Glucose metabolism indicators:Hemoglobin A1c (HbA1c) [Time frame: From the date of randomization until the end of the 24-week intervention period]
- Glucose metabolism indicators:Fasting blood glucose [Time frame: From the date of randomization until the end of the 24-week intervention period]
- Quality of Life Scale (SF-36) [Time frame: From the date of randomization until the end of the 24-week intervention period]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 3 centers
- Hospital of Chengdu University of Traditional Chinese Medicine — Chengdu
- Deyang Hospital Affiliated to Chengdu University of Traditional Chinese Medicine — Deyang
- Guangyuan North Sichuan Diabetes Specialty Hospital — Guangyuan
Publications
- Mondal R, Deb S, Chowdhury D, Sarkar S, Guha Roy A, Shome G, Sarkar V, Lahiri D, Benito-Leon J. Neurometabolic substrate transport across brain barriers in diabetes mellitus: Implications for cognitive function and neurovascular health. Neurosci Lett. 2024 Nov 20;843:138028. doi: 10.1016/j.neulet.2024.138028. Epub 2024 Oct 24. PMID 39461703
- Martins B, Pires M, Ambrosio AF, Girao H, Fernandes R. Contribution of extracellular vesicles for the pathogenesis of retinal diseases: shedding light on blood-retinal barrier dysfunction. J Biomed Sci. 2024 May 10;31(1):48. doi: 10.1186/s12929-024-01036-3. PMID 38730462
- American Diabetes Association Professional Practice Committee. 2. Diagnosis and Classification of Diabetes: Standards of Care in Diabetes-2024. Diabetes Care. 2024 Jan 1;47(Suppl 1):S20-S42. doi: 10.2337/dc24-S002. PMID 38078589
Identifiers
NCT: NCT06813274 · 2023ZD001