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Multimodal magnetic resonance imaging study of brain structure and function in different glucose metabolism states

Magnetic resonance imaging of the brain, heart, and liver in diabetic patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300075515
Enrollment
Unknown
Registered
2023-09-07
Start date
2023-10-01
Completion date
Unknown
Last updated
2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes mellitus

Interventions

Impaired fasting glucose(IFG):NA
Impaired fasting glucose tolerance(IGT):NA
type 2 diabetes mellitus,T2DM:NA
control group:NA

Sponsors

The First Affiliated Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for the experimental group: (1) According to the World Health Organization (1999) criteria for diagnosing Type 2 diabetes, the experimental group was divided into three groups: impaired fasting glucose (IFG), impaired glucose tolerance (IGT), and diabetes mellitus (T2DM). IFG was defined as a fasting plasma glucose level of 6.1 mmol/L or higher but less than 7.0 mmol/L, and an OGTT 2-hour value of 7.8 mmol/L or lower; IGT was defined as a fasting plasma glucose level of 6.1 mmol/L or higher but less than 7.0 mmol/L, and an OGTT 2-hour value of 7.8 mmol/L to 11.1 mmol/L; T2DM was diagnosed when FPG > 7.0 mmol/L. The participants in the experimental group were not receiving medication for T2DM at the time of study. (2) Participants were between the ages of 40 and 60. (3) They were right-handed. (4) Their educational years had been = 6 years. (5) Their Hamilton Depression Scale (HAMD) scores were less than 8. (6) They did not have any eye diseases that affected their writing, nor did they have language barriers. (7) They did not have any history of cognitive impairment due to conditions such as cerebral hemorrhage, large-area stroke, tumor, brain injury, hypothyroidism, vitamin deficiency, anemia, or liver and kidney dysfunction. (8) They had a clear understanding of the study content and signed a informed consent form. (9) They did not have any contraindications for magnetic resonance imaging (MRI). The inclusion criteria for the control group were as follows: Gender, age, educational level, and dominant hand matched with volunteers who met these criteria. (1) They did not have diabetes (FPG < 3.9 mmol/L or 7.0 mmol/L, and OGTT 2h < 7.8 mmol/L). (2) They did not have subjective memory loss. (3) Their MoCA score was greater than or equal to 26. (4) Their MMSE score was greater than or equal to 24. (5) They were between the ages of 40 and 60. (6) They were right-handed. (7) They had an educational year count of at least six years. (8) Their HAMD scores were less than or equal to 8. (9) They did not have any eye diseases that affected their writing, nor did they have language barriers. (10) They did not have any history of cognitive impairment due to conditions such as cerebral hemorrhage, large-area stroke, tumor, brain injury, hypothyroidism, vitamin deficiency, anemia, or liver and kidney dysfunction. (11) They had a clear understanding of the study content and signed an informed consent form. (12) They did not have any contraindications for MRI.

Exclusion criteria

Exclusion criteria: (1) Exclude cognitive impairment caused by clear causes such as brain injury, brain tumor, cerebral hemorrhage, large-area cerebral infarction, depression/anxiety disorder, Alzheimer's disease, Parkinson's dementia, front temporal lobe dementia, Creutzfeldt-Jakob disease, taking consciousness-altering drugs, etc. (2) Exclude alcohol poisoning. (3) Exclude pulmonary heart disease, acute complications of diabetes mellitus, acute infectious diseases, primary nephropathy, and other major diseases such as hyperthyroidism, heart failure, tumors, etc. (4) Exclude white matter lesions: age-related white matter changes (ARWMC) scoring > 1 point (ARWMC standard: 0 points: no lesion, 1 point: local lesions, 2 points: lesions integrated into a patchwork pattern, 3 points: diffuse involvement throughout the region with or without subcortical U-shaped fibers involved> (5) Exclude the contraindications for magnetic resonance imaging. (6) HAMD score > 8 points.

Design outcomes

Primary

MeasureTime frame
Cortical Thickness, CT;Sulcus Depth, SD;Gyrification Index, GI;Fractal Dimension, FD;Fractional Anisotropy,FA;Mean Diffusivity,MD;Regional Homogeneity,ReHo;Amplitude of Low-frequency Fluctuation, ALFF;Fractional Amplitude of Low-frequency Fluctuation,fALFF;Functional Connectivity,FC;

Secondary

MeasureTime frame
Axial Diffusivity,AD;Radial Diffusivity,RD;

Countries

China

Contacts

Public ContactZENG ZI SAN

Department of Imaging, The First Affiliated Hospital of Guangxi Medical University

zengzisan@aliyun.com+86 133 0771 6608

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026