Clinical trial NCT06428968: Investigating the Insulin Resistance in Individuals With Type 2 Diabetes
Official title: Investigating the Central and Peripheral Insulin Resistance in Individuals With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Insulin resistance
Cognitive impairments
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Numerous studies have provided evidence of a correlation between Type 2 Diabetes Mellitus (T2DM) and cognitive dysfunction, specifically in the realms of complex attention, information processing, and executive function. These impairments have been observed in middle-aged and elderly individuals with T2DM, with longer diabetes duration, suboptimal glycemic control, and the presence of diabetic complications being contributing factors. Recent research in young adults and adolescents diagnosed with T2DM has revealed cognitive and brain structural alterations in this growing demographic, suggesting that early disease mechanisms, rather than solely vascular and age-related neurodegeneration, contribute to pathogenesis. However, there remains uncertainty regarding the interplay between central and peripheral insulin resistance and its impact on cognitive dysfunction in individuals with T2DM. This study aims to investigate central insulin resistance in T2DM, elucidating its association with peripheral insulin resistance and the effects on cognitive impairments.

Detailed description: Participants screened through inclusion and exclusion criteria will accept cross-sectional evaluation. The information of demographic data, medical history, previous and current medication regimen, details of complications, and family history regarding metabolic diseases will be collected. The assessments includes physical examination, anthropometry, blood test(blood routine, liver function, renal function, blood lipids, fasting blood glucose, serum insulin，thyroid function and glycosylated hemoglobin A 1c), MRI scan( High-resolution T1-weighted Anatomical Images, Diffusion Tensor Imaging, Resting-state functional MRI and Arterial Spin Labeling) and psychiatry scales(Hamilton Depression Scale, Young Mania Rating Scale and Self-reporting Inventory-90); cognitive function will be assessed by the Measurement and Treatment Research to Improve Cognition in Schizophrenia(MATRICS) Consensus Cognitive Battery; biological samples also will be collected and stored to explore related mechanisms.

Eligibility criteria: Inclusion Criteria:

* Meeting the diagnostic criteria for Type 2 diabetes: typical symptoms of diabetes plus random blood glucose level of ≥11.1 mmol/l, or fasting blood glucose level of ≥7.0 mmol/l, or 2-hour post-OGTT (Oral Glucose Tolerance Test) blood glucose level of ≥11.1 mmol/l, or HbA1c level of ≥6.5%; for those without typical symptoms of diabetes, re-examination on a different day is required for confirmation.

Exclusion Criteria:

* Having history of substance dependence or abuse or whose symptoms are caused by diagnosable mental disorders;
* Having history of traumatic brain injury, seizures or other known neurological or organic diseases of the central nervous system;
* Having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be manage in an inpatient setting;
* Taking drugs that could affect cognitive function.
* The routine blood tests showing significant abnormal renal, liver function or other somatic disease.
* Pregnant or lactating women.

Primary outcomes:
measure: The difference of changes of brain cerebral blood flow by arterial spin labeling between type 2 diabetes and healthy volunteers.
timeFrame: Baseline
measure: The difference of the level of insulin signaling in Extracellular Vesicles of neuronal origin isolated from blood between type 2 diabetes and healthy volunteers.
timeFrame: Baseline
measure: The difference of the score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery between type 2 diabetes and healthy volunteers.
timeFrame: Baseline
measure: The difference of c-fMRI between type 2 diabetes and healthy volunteers.
timeFrame: Baseline
Secondary outcomes:
measure: The difference of Diffusion Tensor Imaging scanned by MRI between type 2 diabetes and healthy volunteers
timeFrame: Baseline
Other outcomes:
Locations:
city: Changsha
country: China
facility: Department of Psychiatry, National Clinical Research Center for Mental Disorders, and National Center for Mental Disorders, The Second Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: Department of Psychiatry, The Second Xiangya Hospital of Central South University
name: Renrong Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References: