NCT07837258Toborzás még nem indult
Serum Sulfate and Brain Function in Diabetic Encephalopathy
A Cross-sectional Study on the Correlation Between Serum Sulfate Ion Levels and Brain Function in Patients With Diabetic Encephalopathy
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 23.
Rövid összefoglaló (regiszter, angolul)
The goal of this observational study is to learn about the relationship between sulfate ion levels in the blood and brain function in people with diabetic encephalopathy, a diabetes-related brain condition that can affect thinking and memory. The main questions it aims to answer are: 1. Are blood sulfate ion levels related to memory and thinking test scores? 2. Are blood sulfate ion levels related to the severity of brain shrinkage (brain atrophy) seen on MRI? 3. Do sulfate ion levels and their relationship with thinking and memory differ among people with different levels of long-term blood sugar control? Researchers will compare participants grouped by long-term blood sugar control (based on HbA1c, a blood test that reflects average blood sugar over the past 2-3 months) to see whether sulfate ion levels and their associations with brain function differ. Participants will: 1. Give a blood sample to measure sulfate ion levels, HbA1c, and neurofilament light chain (NfL), a marker of nerve damage. 2. Complete the Montreal Cognitive Assessment (MoCA), a test of memory and thinking, and questionnaires about daily living skills. 3. Have a brain MRI scan to assess brain shrinkage, unless a recent scan within the past 6 months can be used. 4. Provide information about their diabetes and medical history. This is a cross-sectional study, so participants will be assessed once at enrollment. No treatment or intervention is given. About 220 adults aged 45-75 years with type 2 diabetes and diabetic encephalopathy will take part.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 220 (tervezett)
- Első benyújtás
- 2026. szept. 12.
- Kezdés
- 2026. szept. 20.
- Elsődleges befejezés
- 2028. dec. 31.
- Fő szponzor
- Dongzhimen Hospital, Beijing
- Betegségek
- 2-es típusú cukorbetegség
- NCT-szám
- NCT07837258
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 220
- 2026. szept. 20. és az elsődleges befejezés (2028. dec. 31.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Más betegség
- Patients with type 1 diabetes, gestational diabetes, other specific types of diabetes, or participants with unknown diabetes status.
- Cognitive impairment caused by other definite etiologies (e.g., Alzheimer's disease, Lewy body dementia, frontotemporal dementia, central nervous system infection, severe traumatic brain injury, poisoning, etc.).
- Severe infection, major trauma, or surgery within 3 months; active malignancy (except localized skin cancer); or acute or severe systemic diseases that may significantly affect metabolic status or cognitive function.
- Major depressive disorder, schizophrenia, or other psychiatric disorders or delirium that may affect the assessment of cognitive function.
- Severe hearing or visual impairment, MRI contraindications, or any other condition that prevents cooperation with the examinations.
Laborértékek
- Severe hepatic or renal insufficiency (e.g., ALT or AST > 3 times the upper limit of normal, eGFR < 30 mL/min/1.73 m²).
Kiket keres a vizsgálat
- Age 45-75 years, no restriction on sex; patients with type 2 diabetes mellitus who meet the current American Diabetes Association (ADA) Standards of Care in Diabetes or the World Health Organization (WHO) diagnostic criteria for diabetes, with a confirmed disease duration ≥ 6 years.
- Cranial plain magnetic resonance imaging (MRI; sequences including at least T1WI, T2WI, and FLAIR) with a radiological report indicating age-inappropriate brain atrophy (e.g., ventricular enlargement, widened sulci). Concomitant prior cerebral infarction or cerebral small vessel disease changes (e.g., lacunar infarction, white matter hyperintensities, etc.) are allowed. Other major structural causes that may lead to cognitive impairment, such as cerebral hemorrhage and space-occupying lesions, are excluded. Patients with acute cerebral infarction at least 2 weeks after onset, with stable vital signs and metabolic status, who are able to complete the MoCA assessment and MRI examination, are allowed.
- Montreal Cognitive Assessment (MoCA) score < 26.
- Education level of primary school or above; able to communicate well with the investigators and comply with all study requirements.
- Voluntarily participate in this study and provide signed informed consent.
Életkor a regiszterben: 45 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.