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NCT Number: NCT06650969

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

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.

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Key information

Conditions

Type 2 Diabetes Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Mental Disorders Metabolic Diseases Mild Cognitive Impairment Nervous System Diseases Neurocognitive Disorders Nutritional and Metabolic Diseases Subjective Cognitive Decline

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Nanjing, Jiangsu, 210008, China

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Naturalistic observation

Other

Naturalistic observation

Primary outcomes

  1. Prevalence, incidence of cognitive dysfunction in type 2 diabetes

    Time frame: From 2016 to 2034

    Prevalence, incidence of mild cognitive impairment in type 2 diabetes

  2. Risk factors for cognitive dysfunction in type 2 diabetes, such as diabetes duration, poor glycemic control, hypertension, obesity, dyslipidemia, and active inflammation, et al.

    Time frame: From 2016 to 2034

    Risk factors for the occurrence and progression of mild cognitive impairment in type 2 diabetes, such as diabetes duration, poor glycemic control, hypertension, obesity, dyslipidemia, and active inflammation, et al.

  3. Biomarkers of cognitive dysfunction in type 2 diabetes

    Time frame: From 2016 to 2034

    Diagnostic biomarkers, predictive biomarkers, and prognostic biomarkers of cognitive dysfunction in type 2 diabetes

  4. Glycemic control targets for cognitive dysfunction in type 2 diabetes

    Time frame: From 2016 to 2034

    Glycemic control targets (including glycated hemoglobin, glycemic fluctuations and hypoglycemic events) for slowing or reversing disease progression of cognitive dysfunction in type 2 diabetes.

Interested in participating?

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Interested in participating?

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Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Important dates

Study start
2016
Primary completion
2034
Study completion
2034
First posted
Oct 21, 2024
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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