The Application of an AI-driven Multimodal Predictive Model for Cognitive Impairment in Patients With Type 2 Diabetes Mellitus
NCT ID: NCT07128186
Last Updated: 2025-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
5000 participants
OBSERVATIONAL
2025-04-22
2028-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cognitive Normal Group
Healthy control group without significant cognitive impairment in the study
follow-up observation
In this study, no additional interventions were administered to any enrolled participants; only 3-5 years of follow-up observation were conducted, with cognitive status data collected at both baseline and endpoint.
Mild Cognitive Impairment Group
An intermediate state with subjective or objective cognitive decline (e.g., memory, executive function) that does not meet the diagnostic criteria for dementia
follow-up observation
In this study, no additional interventions were administered to any enrolled participants; only 3-5 years of follow-up observation were conducted, with cognitive status data collected at both baseline and endpoint.
Interventions
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follow-up observation
In this study, no additional interventions were administered to any enrolled participants; only 3-5 years of follow-up observation were conducted, with cognitive status data collected at both baseline and endpoint.
Eligibility Criteria
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Inclusion Criteria
2. Aged 40-75 years, with self-reported or informant-reported memory complaints.
3. Cognitive assessment scores consistent with either:
* Cognitive Normal (CN) or
* Mild Cognitive Impairment (MCI).
4. Preserved ability to perform basic activities of daily living (ADLs).
5. Memory-specific deficits only (e.g., partial forgetfulness), with intact other cognitive domains (e.g., reasoning, judgment, attention, and executive function).
Exclusion Criteria
2. Education level \<6 years.
3. Metabolic disorders that may affect cognition, including:
* Acute carbohydrate metabolism events within 3 months (e.g., severe hypoglycemia, diabetic ketoacidosis, hyperglycemic hyperosmolar state).
* Hypothyroidism or other endocrine disorders.
4. Neurological/psychiatric conditions that may impair cognition:
* History of head trauma, depression, anxiety, delirium, severe pulmonary/renal disease, heart failure, or malignancy.
5. Substance abuse (past 2 years), including nicotine/alcohol dependence.
6. Recent medication use (within 1 month):
* Anti-Parkinsonian drugs, antiepileptics, sedatives/hypnotics.
7. Cognitive-enhancing drugs (e.g., donepezil, memantine).
8. Inability to complete AI screening or follow-up due to:
* Speech/hearing/visual impairments or other disabilities
40 Years
75 Years
ALL
Yes
Sponsors
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Tongji Hospital
OTHER
Responsible Party
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Yangyan
Principal Investigator
Locations
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Minda Hospital Affiliated to Hubei Minzu University
Enshi, Hubei, China
Huanggang Central Hospital
Huanggang, Hubei, China
Huangshi Central Hospital
Huangshi, Hubei, China
Jingzhou Central Hospital
Jingzhou, Hubei, China
Sinopharm Dongfeng General Hospital
Shiyan, Hubei, China
Suizhou Central Hospital
Suizhou, Hubei, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
China Resources & WISCO General Hospital
Wuhan, Hubei, China
Hubei Provincial Hospital of Integrated Chinese & Western Medicine
Wuhan, Hubei, China
Tianyou Hospital Affiliated to Wuhan University of Science and Technology
Wuhan, Hubei, China
Wuhan Central Hospital
Wuhan, Hubei, China
Wuhan Fifth Hospital
Wuhan, Hubei, China
Wuhan Fourth Hospital
Wuhan, Hubei, China
Xiangyang Central Hospital
Xiangyang, Hubei, China
Xiangyang First People's Hospital
Xiangyang, Hubei, China
Xianning Central Hospital
Xianning, Hubei, China
Xiantao First People's Hospital
Xiantao, Hubei, China
Xiaogan Central Hospital
Xiaogan, Hubei, China
Renhe Hospital Affiliated to China Three Gorges University
Yichang, Hubei, China
Sinopharm Gezhouba Central Hospital
Yichang, Hubei, China
Yichang Central People's Hospital
Yichang, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TJ-IRB202503076
Identifier Type: -
Identifier Source: org_study_id
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