Clinical trial NCT05590442: Risk Model of Cognitive Impairment in Diabetes
Official title: Early Diagnosis and Risk Evaluation of Mild Cognitive Impairment in Diabetes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 2 Diabetes Mellitus
Mild Cognitive Impairment
Keywords: Cognitive Assessments
Olfactory Test
Risk Model
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 500
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetes

Brief summary: Development and validation of a risk model for predicting the risk of mild cognitive impairment among individuals of type 2 diabetes.


Eligibility 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.

Primary outcomes:
measure: The rate of mild cognitive impairment occurrence
timeFrame: 1 year
Secondary outcomes:
measure: Glycaemic control measured by blood test.
timeFrame: 1 day
measure: Physical assessments.
timeFrame: 1 day
measure: Olfactory threshold test
timeFrame: 1 day
measure: Olfactory memory test
timeFrame: 1 day
measure: Montreal Cognitive Assessment (MoCA) score
timeFrame: 1 day
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
state: Jiangsu
Study officials:
References:
citation: Zhang Z, Zhang B, Wang X, Zhang X, Yang QX, Qing Z, Zhang W, Zhu D, Bi Y. Olfactory Dysfunction Mediates Adiposity in Cognitive Impairment of Type 2 Diabetes: Insights From Clinical and Functional Neuroimaging Studies. Diabetes Care. 2019 Jul;42(7):1274-1283. doi: 10.2337/dc18-2584. Epub 2019 May 21.
citation: Zhang Z, Zhang B, Wang X, Zhang X, Yang QX, Qing Z, Lu J, Bi Y, Zhu D. Altered Odor-Induced Brain Activity as an Early Manifestation of Cognitive Decline in Patients With Type 2 Diabetes. Diabetes. 2018 May;67(5):994-1006. doi: 10.2337/db17-1274. Epub 2018 Mar 2.
citation: Cheng H, Zhang Z, Zhang B, Zhang W, Wang J, Ni W, Miao Y, Liu J, Bi Y. Enhancement of Impaired Olfactory Neural Activation and Cognitive Capacity by Liraglutide, but Not Dapagliflozin or Acarbose, in Patients With Type 2 Diabetes: A 16-Week Randomized Parallel Comparative Study. Diabetes Care. 2022 May 1;45(5):1201-1210. doi: 10.2337/dc21-2064.