Risk Model of Cognitive Impairment in Diabetes

Early Diagnosis and Risk Evaluation of Mild Cognitive Impairment in Diabetes

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

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes Mellitus; Mild Cognitive Impairment
• Intervention / Treatment: Other: Tests

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Bi Yan, MD, PhD; Phone Number: +8602583106666; Email: biyan@nju.edu.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
      • Contact: Yan Bi, MD,PhD; Email: biyan@gmail.com
      • Contact: Zhou Zhang, MD,PhD; Email: zhangzhou@smail.nju.edu.cn
      • Principal Investigator: Zhou Zhang, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Type 2 diabetes

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Cognitive assessments and olfactory tests
Validation cohort; The validation cohort will be used to validate the results obtained using the training cohort.	Other: Tests; Cognitive assessments and olfactory tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycaemic control measured by blood test.	HbA1c	1 day
Physical assessments.	BMI(body mess index) in kg/m^2	1 day
Olfactory threshold test	The same odor with 2 different concentrations are given to the participant each time to find out which one is more intense. (Olfactory software will analyse and give threshold score depending on participant's choice.)	1 day
Olfactory memory test	PART A: Participants are shown 4 pictures for each odor(10 odors in total). They select what they sniffed. 10 minutes break. PART B: Participants sniff 20 different odors , 10 of which are same odors in PART A. They select the picture and figure out whether the odor is old or new.	1 day
Montreal Cognitive Assessment (MoCA) score	The MoCA is a cognitive screening test designed to assist health professionals in detection of mild cognitive impairment.	1 day

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Cognitive Assessments; Olfactory Test; Risk Model
• Additional Relevant MeSH Terms: Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Neurocognitive Disorders; Endocrine System Diseases; Cognition Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2; Cognitive Dysfunction
• Other Study ID Numbers: MCImodel2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No