This study does not involve any treatment or intervention.
OtherThis study does not involve any treatment or intervention.
NCT Number: NCT07837258
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.
Trial opening soon.
Get Notified45 year–75 year
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This study does not involve any treatment or intervention.
Time frame: At enrollment (single blood draw; cross-sectional assessment)
Serum sulfate ion concentration, measured in mmol/L by ion chromatography. Analyzed as a continuous variable; no predefined minimum or maximum. Higher values indicate higher serum sulfate ion levels.
Time frame: At enrollment (reflecting glycemic control over the preceding 2-3 months)
Glycated hemoglobin (HbA1c) level, measured as a percentage (%) by a standardized assay. Reflects average blood glucose over the preceding 2-3 months. Analyzed as a continuous variable; higher values indicate poorer long-term glycemic control.
Time frame: At enrollment (single cross-sectional assessment)
Total score on the Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30, with higher scores indicating better cognitive function.
Time frame: At enrollment; baseline MRI, or prior MRI within 6 months if it meets study criteria
Brain atrophy assessed on cranial MRI (T1WI, T2WI, FLAIR) by experienced radiologists using standardized visual rating scales (e.g., MTA, GCA, and/or Evans index). Severity graded as none, mild, moderate, or severe, or per the selected validated scale; higher grades indicate more severe atrophy (worse outcome).
Time frame: At enrollment (single cross-sectional assessment)
Visuospatial/executive function domain score on the MoCA. Scores range from 0 to 5, with higher scores indicating better visuospatial/executive function.
Time frame: At enrollment (single cross-sectional assessment)
Naming domain score on the MoCA. Scores range from 0 to 3, with higher scores indicating better naming ability.
Time frame: At enrollment (single cross-sectional assessment)
Attention domain score on the MoCA. Scores range from 0 to 6, with higher scores indicating better attention.
Time frame: At enrollment (single cross-sectional assessment)
Language domain score on the MoCA. Scores range from 0 to 3, with higher scores indicating better language function.
Time frame: At enrollment (single cross-sectional assessment)
Abstraction domain score on the MoCA. Scores range from 0 to 2, with higher scores indicating better abstract reasoning.
Time frame: At enrollment (single cross-sectional assessment)
Delayed recall domain score on the MoCA. Scores range from 0 to 5, with higher scores indicating better memory.
Time frame: At enrollment (single cross-sectional assessment)
Orientation domain score on the MoCA. Scores range from 0 to 6, with higher scores indicating better orientation.
Time frame: At enrollment (single cross-sectional assessment)
Total score on the Barthel Index, a scale used to assess functional independence in basic activities of daily living (ADL). Scores range from 0 to 100, with higher scores indicating greater independence (better outcome).
Time frame: At enrollment (single cross-sectional assessment)
Total score on the Lawton Instrumental Activities of Daily Living Scale (IADL), which assesses independence in complex daily activities such as telephone use, shopping, food preparation, housekeeping, laundry, transportation, medication management, and handling finances. Scores range from 0 to 8, with higher scores indicating greater independence (better outcome).
Time frame: At enrollment (single blood draw; cross-sectional assessment)
Serum neurofilament light chain (NfL) level, measured in pg/mL by a validated immunoassay. Higher levels indicate greater neuroaxonal injury (worse outcome). Analyzed as a continuous variable.
Trial opening soon.
Get NotifiedDongzhimen Hospital, Beijing
Other
A Cross-sectional Study on the Correlation Between Serum Sulfate Ion Levels and Brain Function in Patients With Diabetic Encephalopathy
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