NCT05545657

Brief Summary

This is a cross-sectional and longitudinal study to investigate the relationship and central mechanism between type 2 diabetes and cognitive impairment based on the simultaneous EEG-fMRI approach and peripheral neuropathology biomarkers assay.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

October 18, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

October 26, 2022

Status Verified

August 1, 2022

Enrollment Period

2.7 years

First QC Date

September 6, 2022

Last Update Submit

October 23, 2022

Conditions

Type 2 DiabetesAlzheimer DiseaseCognitive Impairment

Outcome Measures

Primary Outcomes (5)

  • Baseline cognitive performance

    The Montreal Cognitive Assessment (MoCA) score, ranges from 0 to 30, and higher scores mean better cognition.

    Day 1 of entry study

  • Baseline peripheral blood neuropathology biomarkers level

    Aβ40, Aβ42, P-tau 181, P-tau 231, GFAP and NfL.

    Blood samples will be collected on day 1 of the entry study and preserved at -81 °C in the Biobank of Drum Tower Hospital until examination.

  • Baseline simultaneous EEG-fMRI

    Frequency domain and spectrum domain analyses

    Within 1 week after cognitive assessments

  • Baseline brain structural MRI scan

    Cortical morphology

    Within 1 week after cognitive assessments

  • Baseline brain functional MRI scan

    Large-scale network functional connectivity

    Within 1 week after cognitive assessments

Secondary Outcomes (5)

  • Longitudinal changes of cognitive performance

    From baseline to each follow-up time points (6 months, 12 months, 18 months, 24 months, 30months, 36 months).

  • Longitudinal changes of peripheral blood neuropathology biomarkers level

    From baseline to final follow-up time points (36 months).

  • Longitudinal changes of simultaneous EEG-fMRI

    From baseline to each follow-up time points (6 months, 12 months, 18 months, 24 months, 30months, 36 months).

  • Longitudinal changes of brain structural MRI scan

    From baseline to each follow-up time points (6 months, 12 months, 18 months, 24 months, 30months, 36 months).

  • Longitudinal changes of brain functional MRI scan

    From baseline to each follow-up time points (6 months, 12 months, 18 months, 24 months, 30months, 36 months).

Study Arms (2)

Type 2 Diabetes

These patients must have a definite diagnosis of type 2 diabetes mellitus (T2DM) according to the American Diabetes Association (ADA) standards. Some of these patients have symptoms of cognitive impairment, while others have normal cognition.

Behavioral: Cognitive assessmentsOther: Simultaneous EEG-fMRI scanOther: Multimodal magnetic resonance imagingOther: Peripheral blood neuropathology biomarkers assay

Healthy Control

These participants have normal glucose tolerance and normal cognition.

Behavioral: Cognitive assessmentsOther: Simultaneous EEG-fMRI scanOther: Multimodal magnetic resonance imagingOther: Peripheral blood neuropathology biomarkers assay

Interventions

Cognitive assessmentsBEHAVIORAL

Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Rey Auditory Verbal Learning Test (RAVLT), Boston Naming Test (BNT), Digit Span Test (DST), Trail Making Test (TMT).

Healthy ControlType 2 Diabetes
Simultaneous EEG-fMRI scanOTHER

EEG recordings were conducted with a 64-channel MR-compatible EEG system (Electrical Geodesics Inc., Eugene, OR, USA) and an MR-compatible EEG cap (HydroCel Geodesic Sensor Nets), using ring-type sintered silver chloride electrodes with iron-free copper leads.

Healthy ControlType 2 Diabetes
Multimodal magnetic resonance imagingOTHER

3D T1-weighted imaging, Resting-state fMRI, Diffusion tensor imaging, Arterial spin labeling.

Healthy ControlType 2 Diabetes
Peripheral blood neuropathology biomarkers assayOTHER

Detecting the peripheral blood neuropathology biomarkers using single molecule array (Simoa) technique, including Aβ40, Aβ42, P-tau 181, P-tau 231, GFAP and NfL.

Healthy ControlType 2 Diabetes

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

T2DM patients will be recruited from the outpatient and inpatient units of the endocrinology department of the investigator's hospital. Healthy control will be recruited in the community

You may qualify if:

  • Aged 40-75 years
  • Right handedness
  • Possessed over 6-year education
  • Provision of informed consent prior to any study specific procedures

You may not qualify if:

  • Control participants would be excluded if they had a fasting blood glucose level \>7.0 mmol/L; glucose level\> 7.8 mmol/L after oral glucose tolerance test (OGTT); HbA1c\>5.7%
  • Control participants would be excluded if they had a Montreal Cognitive Assessment (MoCA, Beijing edition) score of \< 26
  • History of other dementia-related neurological or psychiatric disorders, including psychotic developmental disorders, mania, depression, and schizophrenia
  • Central neural system diseases, including traumatic brain injury, intracranial hemorrhage, and acute cerebral infarction
  • Acute complications of diabetes, including diabetic ketoacidosis, hyperglycemic hyperosmolar state, and hypoglycemic coma
  • Complicated with severe impairment of liver, kidney or heart function
  • Metal implants, unable to complete the MR scanning
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiology, the Affiliated Drum Tower Hospital of Nanjing University

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Alzheimer DiseaseCognitive Dysfunction

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Central Study Contacts

Bing Zhang, MD, PhD

CONTACT

86-15851803070zhangbing_nanjing@vip.163.com

Wen Zhang, MD, PhD

CONTACT

86-15950576908zw7830254@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2022

First Posted

September 19, 2022

Study Start

October 18, 2022

Primary Completion

June 30, 2025

Study Completion

August 31, 2025

Last Updated

October 26, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

IPD sharing will be made during the 12 months after the end of study, and the original data can be obtained from the PI if necessary.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
during the 12 months after the end of study

Locations

CN(1)