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Study on neuroimaging markers of T2DM with MCI based on multivariate and multimodal images

Study on neuroimaging markers of T2DM with MCI based on multivariate and multimodal images

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100046000
Enrollment
Unknown
Registered
2021-05-02
Start date
2021-05-03
Completion date
Unknown
Last updated
2021-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus with mild cognitive impairment

Interventions

Type 2 diabetes mellitus with mild cognitive impairment group:no
Healthy subjects:no
Type 2 diabetes mellitus without cognitive dysfunction group:no
Mild cognitive impairment without Type 2 diabetes mellitus:no

Sponsors

Fujian University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria for type 2 diabetes and MCI 1. Diagnostic criteria (1) Diabetes diagnosis criteria: 2018 American Diabetes Association and World Health Organization Diabetes Diagnosis Standards: 1) FBG>7.0mmol/L (126 mg/dl); 2) 2 hours after 75g oral glucose tolerance test (OGTT) test, blood glucose> 11.1mmol/L (200mg/dl); 3) HbA1c >= 6.5% (48mmol/L); 4) Random blood glucose >= 11.1mmol/L (200mg/dl). Diabetes can be diagnosed by satisfying one of them. The type 2 diabetes was diagnosed by a medical history review and a specialist doctor. (2) The diagnostic criteria for mild cognitive impairment refer to the 2004 Petersen diagnostic criteria, which are as follows: 1) Confirm the existence of cognitive impairment by the patient, insider, or experienced clinician; 2) There are impairments in one or more cognitive domains (memory, language, visual space or executive function); 3) The functional activities are basically normal; 4) No dementia. (2) Inclusion criteria: 1) Meet the diagnostic criteria for type 2 diabetes and mild cognitive impairment at the same time; 2) Aged >= 60 years; 3) MoCA score = 60 years; 2. MoCA score >=26; 3. Does not meet the diagnostic criteria for type 2 diabetes; 4. Does not meet the diagnostic criteria of MCI; 5. Sign informed consent and participate voluntarily. Inclusion criteria for subjects with type 2 diabetes without cognitive impairment: 1. It meets the diagnostic criteria for type 2 diabetes and does not meet the MCI diagnostic criteria; 2. Aged >= 60 years; 3. MoCA score >=26; 4. Informed consent, voluntary participation. Inclusion criteria for subjects with mild cognitive impairment without type 2 diabetes 1. Meet the MCI inclusion criteria; 2. Age >= 60 years old; 3. MoCA score <26; 4. Does not meet the diagnostic criteria for type 2 diabetes; 5. Informed consent, voluntary participation.

Exclusion criteria

Exclusion criteria: Exclusion criteria for subjects with type 2 diabetes and MCI 1. Depressed patients with a simplified version of the Geriatric Depression Scale (GDS-15) score >= 9; 2. Patients with cognitive impairment caused by taking drugs (antipsychotic drugs, benzodiazepines, etc.), poisoning and other reasons; 3. Those with uncontrollable hypertension (systolic blood pressure greater than 160mmHg or diastolic blood pressure greater than 100mmHg after taking the drug); 4. Poor blood sugar control (glycated hemoglobin > 11%); 5. Diabetic foot, diabetic fundus retina disease (stage IV-VI), diabetic nephropathy (stage IV-V) and other serious complications; 6. Those who cannot complete the index evaluation, such as severe aphasia, visual and hearing impairment, illiteracy, etc.; 7. Those who are participating in other research trials that affect the results of this research. Exclusion criteria for healthy subjects: 1.Severe mental and psychological system diseases such as anxiety, depression, etc.; 2.Patients with uncontrollable hypertension (systolic blood pressure greater than 160mmHg or diastolic blood pressure greater than 100mmHg after taking the drug) or severe hyperlipidemia; 3. Diseases that seriously affect the nervous function of the central nervous system, such as stroke, dementia, epilepsy, Parkinson, cerebrovascular accident, head trauma, brain surgery, etc.; 4. Other diseases that affect cognitive function, taking drugs that affect cognition, infection, poisoning, tumor, cardiovascular disease, abnormal examination results of vitamin B12 and folic acid, and metabolic abnormalities, including serious liver, kidney, gastrointestinal tract Diseases, thyroid dysfunction, etc.; 5. Those who have bad habits that may affect cognition, such as alcohol abuse, drug abuse; 6. In addition to atrophy, lacunar or white matter lesions, infarcts of cerebral small blood vessels larger than 15mm or hemorrhages larger than 5mm are structural brain diseases; 7. Those who cannot complete the indicator evaluation, such as severe aphasia, visual and hearing impairment, illiteracy, etc.; 8. Those who have contraindications to magnetic resonance examination (such as installation of pacemakers, cardiac stents, fixed dentures, metal implants, claustrophobia, high fever, etc.); 9. Those who are participating in other research trials that affect the results of this research. Exclusion criteria for subjects with type 2 diabetes without cognitive impairment 1. Depressed patients with a simplified version of the Geriatric Depression Scale (GDS-15) score >=9; 2. Patients with cognitive impairment caused by taking drugs (antipsychotic drugs, benzodiazepines, etc.), poisoning and other reasons; 3. Those with uncontrollable hypertension (systolic blood pressure greater than 160mmHg or diastolic blood pressure greater than 100mmHg after taking the drug); 4. Poor blood sugar control (glycated hemoglobin>11%); 5. Diabetic foot, diabetic fundus retina disease (stage IV-VI), diabetic nephropathy (stage IV-V) and other serious complications; 6. Those who cannot complete the index evaluation, such as severe aphasia, visual and hearing impairment, illiteracy, etc.; 7. Those who are participating in other research trials that affect the results of this research. Exclusion criteria for subjects with mild cognitive impairment without type 2 diabetes 1. Depressed patients with a simplified version of the Geriatric Depression Scale (GDS-15) score >=9; 2.

Design outcomes

Secondary

MeasureTime frame
Balance and motor function;sensory function;Imaging Indicators;Biochemical indexes;

Primary

MeasureTime frame
cognitive function;

Countries

China

Contacts

Public ContactLiu Jiao

Fujian University of Traditional Chinese Medicine

liujiao0415@outlook.com+86 15860283226

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026