Risk Model of Cognitive Impairment in Diabetes

NCT ID: NCT05590442

Last Updated: 2024-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2025-08-31

Brief Summary

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

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus Mild Cognitive Impairment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Training cohort

The patients will be divided into the training and validation cohorts with a ratio of 7:3. The training cohort will be used to screen variables and construct the model.

Tests

Intervention Type OTHER

Cognitive assessments and olfactory tests

Validation cohort

The validation cohort will be used to validate the results obtained using the training cohort.

Tests

Intervention Type OTHER

Cognitive assessments and olfactory tests

Interventions

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Tests

Cognitive assessments and olfactory tests

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Bi Yan, MD, PhD

Role: CONTACT

+8602583106666

Facility Contacts

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Yan Bi, MD,PhD

Role: primary

Zhou Zhang, MD,PhD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 31221697 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29500313 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35263425 (View on PubMed)

Other Identifiers

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MCImodel2022

Identifier Type: -

Identifier Source: org_study_id

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