Diabetes Mellitus, Type 2NCT07837258
Serum Sulfate and Brain Function in Diabetic Encephalopathy
An observational study of Diabetes Mellitus, Type 2 and Cognitive Dysfunction, Cognitive Disorder, run by Dongzhimen Hospital, Beijing.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Cognitive Dysfunction, Cognitive Disorder, Brain Diseases, Metabolic
- What is being tested?
- This study does not involve any treatment or intervention.
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 45-75 years of either sex with T2DM for ≥6 years and diabetic encephalopathy, defined as MoCA <26 plus MRI evidence of age-inappropriate brain atrophy after excluding other structural causes. Both sexes; primary school education or above; able to complete MoCA/MRI; signed informed consent. Exclusions include type 1/gestational/other diabetes, other causes of cognitive impairment, recent severe illness/trauma/surgery, active malignancy, major psychiatric disorders, severe hepatic/renal insufficiency, and MRI contraindications. Approximately 220 participants will be enrolled.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Cross-sectional Study on the Correlation Between Serum Sulfate Ion Levels and Brain Function in Patients With 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:
- Are blood sulfate ion levels related to memory and thinking test scores?
- Are blood sulfate ion levels related to the severity of brain shrinkage (brain atrophy) seen on MRI?
- 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.
Read more
Participants will:
- Give a blood sample to measure sulfate ion levels, HbA1c, and neurofilament light chain (NfL), a marker of nerve damage.
- Complete the Montreal Cognitive Assessment (MoCA), a test of memory and thinking, and questionnaires about daily living skills.
- Have a brain MRI scan to assess brain shrinkage, unless a recent scan within the past 6 months can be used.
- 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.
- Conditions
- Diabetes Mellitus, Type 2, Cognitive Dysfunction, Cognitive Disorder, Brain Diseases, Metabolic
- Being tested
- This study does not involve any treatment or intervention.
- Keywords
- Diabetic encephalopathy, type 2 diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Cognitive Dysfunction, Brain Diseases, Metabolic, hypoglycemic encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This study does not involve any treatment or intervention.Other
This study does not involve any treatment or intervention.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic encephalopathy | Adults aged 45-75 years of either sex with type 2 diabetes mellitus for ≥6 years and diabetic encephalopathy, defined as MoCA <26 plus MRI evidence of age-inappropriate brain atrophy after excluding other structural causes. Concomitant prior cerebral infarction or small vessel disease changes are allowed. Approximately 220 participants will be enrolled and assessed once at enrollment (cross-sectional), including serum sulfate ion, NfL, HbA1c, MoCA, ADL/IADL, and brain MRI. Receives: Other: This study does not involve any treatment or intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum sulfate ion levels
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.
Measured: At enrollment (single blood draw; cross-sectional assessment)
Long-term glycemic control (HbA1c)
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.
Measured: At enrollment (reflecting glycemic control over the preceding 2-3 months)
Brain function: MoCA total score
Total score on the Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30, with higher scores indicating better cognitive function.
Measured: At enrollment (single cross-sectional assessment)
Brain atrophy assessed by cranial MRI
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).
Measured: At enrollment; baseline MRI, or prior MRI within 6 months if it meets study criteria
Montreal Cognitive Assessment (MoCA) visuospatial/executive function score
Visuospatial/executive function domain score on the MoCA. Scores range from 0 to 5, with higher scores indicating better visuospatial/executive function.
Measured: At enrollment (single cross-sectional assessment)
Montreal Cognitive Assessment (MoCA) naming score
Naming domain score on the MoCA. Scores range from 0 to 3, with higher scores indicating better naming ability.
Measured: At enrollment (single cross-sectional assessment)
Montreal Cognitive Assessment (MoCA) attention score
Attention domain score on the MoCA. Scores range from 0 to 6, with higher scores indicating better attention.
Measured: At enrollment (single cross-sectional assessment)
Montreal Cognitive Assessment (MoCA) language score
Language domain score on the MoCA. Scores range from 0 to 3, with higher scores indicating better language function.
Measured: At enrollment (single cross-sectional assessment)
Montreal Cognitive Assessment (MoCA) abstraction score
Abstraction domain score on the MoCA. Scores range from 0 to 2, with higher scores indicating better abstract reasoning.
Measured: At enrollment (single cross-sectional assessment)
Montreal Cognitive Assessment (MoCA) delayed recall score
Delayed recall domain score on the MoCA. Scores range from 0 to 5, with higher scores indicating better memory.
Measured: At enrollment (single cross-sectional assessment)
Montreal Cognitive Assessment (MoCA) orientation score
Orientation domain score on the MoCA. Scores range from 0 to 6, with higher scores indicating better orientation.
Measured: At enrollment (single cross-sectional assessment)
Secondary outcomes (3)
Barthel Index total score
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).
Measured: At enrollment (single cross-sectional assessment)
Instrumental Activities of Daily Living Scale (IADL) score
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).
Measured: At enrollment (single cross-sectional assessment)
Serum neurofilament light chain (NfL) level
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.
Measured: At enrollment (single blood draw; cross-sectional assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Gao, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837258
- Sponsor's protocol ID
- 2026DZMEC-235-02
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study on the Correlation Between Serum Sulfate Ion Levels and Brain Function in Patients With Diabetic Encephalopathy
- ClinicalTrials.gov ID
- NCT07837258
- Acronym / sponsor ID
- 2026DZMEC-235-02
- Conditions
- Diabetes Mellitus, Type 2, Cognitive Dysfunction, Cognitive Disorder, Brain Diseases, Metabolic
- Keywords
- Diabetic encephalopathy, type 2 diabetes mellitus
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Are blood sulfate ion levels related to memory and thinking test scores?
- Are blood sulfate ion levels related to the severity of brain shrinkage (brain atrophy) seen on MRI?
- 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:
- Give a blood sample to measure sulfate ion levels, HbA1c, and neurofilament light chain (NfL), a marker of nerve damage.
- Complete the Montreal Cognitive Assessment (MoCA), a test of memory and thinking, and questionnaires about daily living skills.
- Have a brain MRI scan to assess brain shrinkage, unless a recent scan within the past 6 months can be used.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic encephalopathy | – | Other: This study does not involve any treatment or intervention.Adults aged 45-75 years of either sex with type 2 diabetes mellitus for ≥6 years and diabetic encephalopathy, defined as MoCA <26 plus MRI evidence of age-inappropriate brain atrophy after excluding other structural causes. Concomitant prior cerebral infarction or small vessel disease changes are allowed. Approximately 220 participants will be enrolled and assessed once at enrollment (cross-sectional), including serum sulfate ion, NfL, HbA1c, MoCA, ADL/IADL, and brain MRI. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 45-75 years of either sex with T2DM for ≥6 years and diabetic encephalopathy, defined as MoCA <26 plus MRI evidence of age-inappropriate brain atrophy after excluding other structural causes. Both sexes; primary school education or above; able to complete MoCA/MRI; signed informed consent. Exclusions include type 1/gestational/other diabetes, other causes of cognitive impairment, recent severe illness/trauma/surgery, active malignancy, major psychiatric disorders, severe hepatic/renal insufficiency, and MRI contraindications. Approximately 220 participants will be enrolled.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This study does not involve any treatment or intervention.This study does not involve any treatment or intervention. | Other | Diabetic encephalopathy |
Primary outcome
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
3 secondary outcomes
Barthel Index total score
Time frame: At enrollment (single cross-sectional assessment)
Instrumental Activities of Daily Living Scale (IADL) score
Time frame: At enrollment (single cross-sectional assessment)
Serum neurofilament light chain (NfL) level
Time frame: At enrollment (single blood draw; cross-sectional assessment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Cognitive Dysfunction, Cognitive Disorder, run by Dongzhimen Hospital, Beijing.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yifeng Rui (+8617812005760, ruiyifeng@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum sulfate ion levels (time frame: At enrollment (single blood draw; cross-sectional assessment)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.