Predicting cognitive impairment risk in people with type 2 diabetes
Early Diagnosis and Risk Evaluation of Mild Cognitive Impairment in Diabetes
This study is trying to see if certain tests can help predict which people with type 2 diabetes might develop mild cognitive impairment as they get older.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT05590442 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop and validate a risk model that predicts the likelihood of mild cognitive impairment in individuals diagnosed with type 2 diabetes mellitus. The study will involve cognitive assessments, including the Montreal Cognitive Assessment Scale (MoCA) and olfactory tests, to gather data on participants aged 40 to 80 years. By analyzing these assessments, researchers hope to identify key risk factors associated with cognitive decline in this population. The findings could lead to improved screening and early intervention strategies for those at risk.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 40 to 80 years with type 2 diabetes and MoCA scores between 19 and 30.
Not a fit: Patients with significant cognitive impairment (MMSE scores < 24) or other neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance early detection and management of cognitive impairment in patients with type 2 diabetes, potentially improving their quality of life.
How similar studies have performed: Other studies have explored cognitive impairment in diabetes, but this specific risk model approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with type 2 diabetes mellitus ; * Aged:40 -80 years ; * Montreal Cognitive Assessment Scale (MoCA) scores 19 - 30; Exclusion Criteria: * Mini-mental State Examination(MMSE) scores \< 24; * Other dementia related neurological diseases or depression, schizophrenia in the past 2 years; * Central nervous system diseases, including brain trauma, intracranial hemorrhage, acute cerebral infarction; * Severe sinusitis, nasal cavity and sinus polyps, skull base or nasopharyngeal tumors and other space occupying lesions, congenital diseases and traumatic history of nose, maxillofacial and skull base affecting olfaction; * Diabetic acute and chronic complications, including diabetic ketoacidosis, a hyperglycemic hyperosmolar state or severe hypoglycemic coma.
Where this trial is running
Nanjing, Jiangsu
- Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Bi Yan, MD, PhD
- Email: biyan@nju.edu.cn
- Phone: +8602583106666
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.