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NCT Number: NCT07837258

Serum Sulfate and Brain Function in Diabetic Encephalopathy

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 hepatic or renal insufficiency (e.g., ALT or AST > 3 times the upper limit of normal, eGFR < 30 mL/min/1.73 m²).
  • Severe hearing or visual impairment, MRI contraindications, or any other condition that prevents cooperation with the examinations.

Treatment and study plan

This study does not involve any treatment or intervention.

Other

This study does not involve any treatment or intervention.

Primary outcomes

  1. Serum sulfate ion levels

    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.

  2. Long-term glycemic control (HbA1c)

    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.

  3. Brain function: MoCA total score

    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.

  4. Brain atrophy assessed by cranial MRI

    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).

  5. Montreal Cognitive Assessment (MoCA) visuospatial/executive function score

    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.

  6. Montreal Cognitive Assessment (MoCA) naming score

    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.

  7. Montreal Cognitive Assessment (MoCA) attention score

    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.

  8. Montreal Cognitive Assessment (MoCA) language score

    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.

  9. Montreal Cognitive Assessment (MoCA) abstraction score

    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.

  10. Montreal Cognitive Assessment (MoCA) delayed recall score

    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.

  11. Montreal Cognitive Assessment (MoCA) orientation score

    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.

Secondary outcomes

  1. Barthel Index total score

    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).

  2. Instrumental Activities of Daily Living Scale (IADL) score

    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).

  3. Serum neurofilament light chain (NfL) level

    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.

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Sponsors and collaborators

Lead sponsor

Dongzhimen Hospital, Beijing

Other

Registry information

Official study title

A Cross-sectional Study on the Correlation Between Serum Sulfate Ion Levels and Brain Function in Patients With Diabetic Encephalopathy

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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