An observational study in Diabetes Mellitus, Type 2, Cognitive Dysfunction, Cognitive Disorder and Brain Diseases, Metabolic, sponsored by Dongzhimen Hospital, Beijing. Not yet recruiting. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Dongzhimen Hospital, Beijing · Observational
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:
Participants will:
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 220 is below the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Dongzhimen Hospital, Beijing is the lead sponsor of 45 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: This study does not involve any treatment or intervention.
This study does not involve any treatment or intervention.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At enrollment (single cross-sectional assessment)
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).
Time frame: 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).
Time frame: 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.
Time frame: At enrollment (single blood draw; cross-sectional assessment)
No study locations are listed for this record.
Start is estimated for Sep 2026; primary completion for Dec 2028, 27 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Dongzhimen Hospital, Beijing