Investigating insulin resistance and cognitive function in Type 2 Diabetes
Investigating the Central and Peripheral Insulin Resistance in Individuals With Type 2 Diabetes
This study is testing how insulin resistance affects thinking skills in people with Type 2 Diabetes, including those who are middle-aged, older, or younger, while also trying a nasal insulin spray to see if it helps.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Central South University Academic / other |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT06428968 on ClinicalTrials.gov |
What this trial studies
This study examines the relationship between insulin resistance and cognitive impairments in individuals with Type 2 Diabetes Mellitus (T2DM). It involves a cross-sectional evaluation of participants who meet specific inclusion criteria, collecting demographic data, medical history, and conducting various assessments including blood tests, MRI scans, and cognitive function tests. The study aims to clarify how central insulin resistance may affect cognitive dysfunction, particularly in middle-aged and elderly individuals, as well as in younger populations diagnosed with T2DM. Participants will also receive a nasal insulin spray as part of the intervention.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with Type 2 Diabetes who meet specific blood glucose criteria.
Not a fit: Patients with significant neurological disorders, substance abuse history, or those currently taking medications affecting cognitive function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of cognitive dysfunction in patients with Type 2 Diabetes.
How similar studies have performed: While there is existing research on the cognitive impacts of Type 2 Diabetes, this specific investigation into central insulin resistance is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Changsha, Hunan
- Department of Psychiatry, National Clinical Research Center for Mental Disorders, and National Center for Mental Disorders, The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
Study contacts
- Principal investigator: Renrong Wu, PhD — Department of Psychiatry, The Second Xiangya Hospital of Central South University
- Study coordinator: Jing Huang, MD
- Email: jinghuangserena001@csu.edu.cn
- Phone: 15874290980
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.