Risk Model of Cognitive Impairment in Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Early Diagnosis and Risk Evaluation of Mild Cognitive Impairment in Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05590442
• Other study ID #: MCImodel2022
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Mild Cognitive Impairment
• Type 2 Diabetes Mellitus

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