Early diagnosis and intervention for cognitive dysfunction in diabetes patients
China Diabetes Cognitive Dysfunction Early Diagnosis and Intervention Study (China-DECODE Study)
This study is trying to find early signs of thinking problems in people over 45 with Type 2 diabetes to help them get better care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06650969 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on individuals aged 45 and older with Type 2 diabetes to assess cognitive function and identify early signs of cognitive decline. Participants will undergo a series of neuropsychological tests, laboratory examinations, brain MRI, and olfactory function measurements to gather comprehensive data on their cognitive health. The study aims to address the current limitations in diagnosing and managing cognitive dysfunction in diabetes patients by collecting and analyzing various biological samples. By enhancing understanding and early intervention strategies, the study seeks to improve outcomes for this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 45 and older who have been diagnosed with Type 2 diabetes.
Not a fit: Patients with a history of dementia or significant neurological or psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early diagnosis and intervention strategies for cognitive dysfunction in patients with Type 2 diabetes.
How similar studies have performed: While there is limited research specifically targeting cognitive dysfunction in diabetes, similar studies have shown promise in understanding the relationship between diabetes and cognitive decline.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥45 years; * Type 2 diabetes diagnosed according to the American Diabetes Association criteria; * Willingness and ability to complete systematic neuropsychological tests; * Understanding of the research procedures and methods, potential benefits and risks of the trial, and sign written informed consent. Exclusion Criteria: * Fewer than 6 years of education; * Left-handedness; * Dementia; * Acute metabolic complications such as diabetic ketoacidosis, hyperglycaemic hyperosmolar state and hypoglycaemic coma within the previous 3 months; * History or presence of neurological or psychiatric disorders; * Presence of hypothyroidism; * History of malignancy, or severe kidney or liver dysfunction.
Where this trial is running
Nanjing, Jiangsu
- Department of Endocrinology, Endocrine and Metabolic Disease Medical Center, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Yan Bi, M.D., Ph.D.
- Email: biyan@nju.edu.cn
- Phone: (86) 25-83105313
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.