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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05590442
Other study ID # MCImodel2022
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2022
Est. completion date August 31, 2025

Study information

Verified date March 2024
Source The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Contact Bi Yan, MD, PhD
Phone +8602583106666
Email biyan@nju.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date August 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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 Design


Intervention

Other:
Tests
Cognitive assessments and olfactory tests

Locations

Country Name City State
China Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Glycaemic control measured by blood test. HbA1c 1 day
Secondary Physical assessments. BMI(body mess index) in kg/m^2 1 day
Secondary 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
Secondary 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
Secondary 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
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