Type 2 DiabetesNCT06650969
China Diabetes Cognitive Dysfunction Early Diagnosis and Intervention Study (China-DECODE Study)
An observational study of Type 2 Diabetes and Subjective Cognitive Decline, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Subjective Cognitive Decline, Mild Cognitive Impairment
- What is being tested?
- Naturalistic observation
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2016to 1 Oct 2034
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study is a dynamic prospective cohort study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Endocrinology, Endocrine and Metabolic Disease Medical Center, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, 210008
Yan Bi, M.D., Ph.D., (86) 25-83105313, biyan@nju.edu.cn
Zhou Zhang, M.D., Ph.D., (86) 25-83106666, zhangzhou@smail.nju.edu.cn
About this 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.
Read the 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
- Being tested
- Naturalistic observation
- Medical subject headings
- Diabetes Mellitus, Type 2, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naturalistic observationOther
Naturalistic observation
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence, incidence of cognitive dysfunction in type 2 diabetes
Prevalence, incidence of mild cognitive impairment in type 2 diabetes
Measured: From 2016 to 2034
Risk factors for cognitive dysfunction in type 2 diabetes, such as diabetes duration, poor glycemic control, hypertension, obesity, dyslipidemia, and active inflammation, et al.
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.
Measured: From 2016 to 2034
Biomarkers of cognitive dysfunction in type 2 diabetes
Diagnostic biomarkers, predictive biomarkers, and prognostic biomarkers of cognitive dysfunction in type 2 diabetes
Measured: From 2016 to 2034
Glycemic control targets for cognitive dysfunction in type 2 diabetes
Glycemic control targets (including glycated hemoglobin, glycemic fluctuations and hypoglycemic events) for slowing or reversing disease progression of cognitive dysfunction in type 2 diabetes.
Measured: From 2016 to 2034
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start1 Oct 2016
- Primary completion1 Oct 2034 (estimated)
- Study completion1 Oct 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Bi, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Yan Bi, M.D., Ph.D., Study director, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650969
- Sponsor's protocol ID
- DECODE2024
- Status last verified
- Oct 2024
- First submitted
- 15 Oct 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Diabetes Cognitive Dysfunction Early Diagnosis and Intervention Study (China-DECODE Study)
- ClinicalTrials.gov ID
- NCT06650969
- Acronym / sponsor ID
- DECODE2024
- Conditions
- Type 2 Diabetes, Subjective Cognitive Decline, Mild Cognitive Impairment, Dementia, Cognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Oct 2034 (estimated)
- Study completion
- 1 Oct 2034 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study is a dynamic prospective cohort study.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naturalistic observationNaturalistic observation | Other | – |
Primary outcome
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
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.
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yan Bi, M.D., Ph.D. study director
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Subjective Cognitive Decline, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Bi, M.D., Ph.D. ((86) 25-83105313, biyan@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence, incidence of cognitive dysfunction in type 2 diabetes (time frame: From 2016 to 2034). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024; AzTrials last refreshed its copy on 26 Oct 2026.