NCT05590442

Brief Summary

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

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 21, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

March 28, 2024

Status Verified

March 1, 2024

Enrollment Period

2.3 years

First QC Date

September 14, 2022

Last Update Submit

March 27, 2024

Conditions

Type 2 Diabetes MellitusMild Cognitive Impairment

Keywords

Cognitive AssessmentsOlfactory TestRisk Model

Outcome Measures

Primary Outcomes (1)

  • The rate of mild cognitive impairment occurrence

    The rate of Montreal Cognitive Assessment(MoCA) scores less than 26 points after 1 year's follow-up.

    1 year

Secondary Outcomes (5)

  • Glycaemic control measured by blood test.

    1 day

  • Physical assessments.

    1 day

  • Olfactory threshold test

    1 day

  • Olfactory memory test

    1 day

  • Montreal Cognitive Assessment (MoCA) score

    1 day

Study Arms (2)

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.

Other: Tests

Validation cohort

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

Other: Tests

Interventions

TestsOTHER

Cognitive assessments and olfactory tests

Training cohortValidation cohort

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Type 2 diabetes

You may qualify if:

  • Patients with type 2 diabetes mellitus ;
  • Aged:40 -80 years ;
  • Montreal Cognitive Assessment Scale (MoCA) scores 19 - 30;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nanjing, Jiangsu, 210008, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 31221697BACKGROUND

  • 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.

    PMID: 29500313BACKGROUND

  • 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.

    PMID: 35263425BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Central Study Contacts

Bi Yan, MD, PhD

CONTACT

+8602583106666biyan@nju.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2022

First Posted

October 21, 2022

Study Start

September 1, 2022

Primary Completion

December 31, 2024

Study Completion

August 31, 2025

Last Updated

March 28, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)