China Diabetes Cognitive Dysfunction Early Diagnosis and Intervention Study (China-DECODE Study)

NCT ID: NCT06650969

Last Updated: 2024-10-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-01
• Study Completion Date: 2034-10-01

Brief Summary

Type 2 diabetes (T2D) and dementia are both diseases with increasing incidence and prevalence globally, leading to substantial economic burdens for families and society. Notably, diabetes significantly increases the risk of cognitive dysfunction, which is classified into preclinical stage, mild cognitive impairment and dementia based on the disease severity. Cognitive dysfunction is a critical contributor to disability and mortality in elderly diabetes patients. Early diagnosis and intervention are crucial for delaying disease progression, enhancing treatment efficacy, and mitigating the impact of dementia. Currently, research and clinical management of cognitive dysfunction in individuals with diabetes are in their infancy, characterized by limitations such as single-center studies, limited sample sizes, inconsistent diagnostic criteria, and insufficient data sharing. Consequently, clinical diagnosis and treatment strategies are underdeveloped, medical staff's related knowledge is lacking, and potential therapeutic targets remain unexplored. In view of these problems and shortcomings, the population cohort study is supposed to be carried out based on accurate diagnosis and constructed the high standard information and sample bank. The study will establish the standard and quality system of T2D with cognitive dysfunction cohort study (unified standards and norms). The study will integrate the standard biological samples stratified acquisition function module (homogeneity and precision) of cognitive dysfunction in T2D, and complete the construction of biological samples bank and clinical diagnosis and treatment information database. The study will apply and develop brain structural and functional imaging technology to support precision diagnosis of cognitive dysfunction in T2D.

Detailed Description

The neuropsychological test battery are used to access the cognitive function of subjects in the study. The laboratory examinations, brain MRI and olfactory function measurements will be done in the screening period. The samples such as plasma, serum, urine and faeces et al. of the subjects will be collected in the study.

Conditions

Type 2 Diabetes; Subjective Cognitive Decline; Mild Cognitive Impairment; Dementia; Cognitive Dysfunction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Naturalistic observation

Naturalistic observation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥45 years;
• Type 2 diabetes diagnosed according to the American Diabetes Association criteria;
• Willingness and ability to complete systematic neuropsychological tests;
• Understanding of the research procedures and methods, potential benefits and risks of the trial, and sign written informed consent.

Exclusion Criteria

• Fewer than 6 years of education;
• Left-handedness;
• Dementia;
• Acute metabolic complications such as diabetic ketoacidosis, hyperglycaemic hyperosmolar state and hypoglycaemic coma within the previous 3 months;
• History or presence of neurological or psychiatric disorders;
• Presence of hypothyroidism;
• History of malignancy, or severe kidney or liver dysfunction.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: lead

Responsible Party

Yan Bi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yan Bi, M.D., Ph.D.

Role: STUDY_DIRECTOR

Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

Locations

Department of Endocrinology, Endocrine and Metabolic Disease Medical Center, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yan Bi, M.D., Ph.D.

Role: CONTACT

biyan@nju.edu.cn

(86) 25-83105313

Zhou Zhang, M.D., Ph.D.

Role: CONTACT

zhangzhou@smail.nju.edu.cn

(86) 25-83106666

Facility Contacts

Yan Bi, M.D., Ph.D.

Role: primary

biyan@nju.edu.cn

(86) 25-83105313

Zhou Zhang, M.D., Ph.D.

Role: backup

zhangzhou@smail.nju.edu.cn

(86) 25-83106666

Other Identifiers

DECODE2024

Identifier Type: -

Identifier Source: org_study_id