Type 2 Diabetes MellitusNCT05590442
Risk Model of Cognitive Impairment in Diabetes
An observational study of Type 2 Diabetes Mellitus and Mild Cognitive Impairment, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
Development and validation of a risk model for predicting the risk of mild cognitive impairment among individuals of type 2 diabetes. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Mild Cognitive Impairment
- What is being tested?
- Tests
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 31 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 2 diabetes
Who may be able to join
- Patients with type 2 diabetes mellitus ;
- Aged:40 -80 years ;
- Montreal Cognitive Assessment Scale (MoCA) scores 19 - 30;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, 210008
Yan Bi, MD,PhD, biyan@gmail.com
Zhou Zhang, MD,PhD, zhangzhou@smail.nju.edu.cn
About this study
Official title: Early Diagnosis and Risk Evaluation of Mild Cognitive Impairment in Diabetes
Development and validation of a risk model for predicting the risk of mild cognitive impairment among individuals of type 2 diabetes.
- Being tested
- Tests
- Keywords
- Cognitive Assessments, Olfactory Test, Risk Model
- Medical subject headings
- Diabetes Mellitus, Type 2, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestsOther
Cognitive assessments and olfactory tests
| Study group | Role | What they receive |
|---|---|---|
| Training cohort | The patients will be divided into the training and validation cohorts with a ratio of 7:3. The training cohort will be used to screen variables and construct the model. Receives: Other: Tests | |
| Validation cohort | The validation cohort will be used to validate the results obtained using the training cohort. Receives: Other: Tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (5)
Glycaemic control measured by blood test.
HbA1c
Measured: 1 day
Physical assessments.
BMI(body mess index) in kg/m^2
Measured: 1 day
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.)
Measured: 1 day
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.
Measured: 1 day
Montreal Cognitive Assessment (MoCA) score
The MoCA is a cognitive screening test designed to assist health professionals in detection of mild cognitive impairment.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start1 Sep 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590442
- Sponsor's protocol ID
- MCImodel2022
- Status last verified
- Mar 2024
- First submitted
- 14 Sep 2022
- Last updated
- 28 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31221697Zhang 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.
PubMed 29500313Cheng 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.
PubMed 35263425Tian S, Wu T, Zhang Z, Lv S, Ji X, Zhao Z, Ma X, Wang J, Bi Y. Activation of central Angiotensin-(1-7)/Mas receptor alleviates synaptic damage in diabetes-associated cognitive impairment via modulating AKT/FOXO1/PACAP axis. Int J Biol Sci. 2025 Apr 9;21(6):2824-2842. doi: 10.7150/ijbs.99617. eCollection 2025.
PubMed 40303297
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis and Risk Evaluation of Mild Cognitive Impairment in Diabetes
- ClinicalTrials.gov ID
- NCT05590442
- Acronym / sponsor ID
- MCImodel2022
- Keywords
- Cognitive Assessments, Olfactory Test, Risk Model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 21 Oct 2022 (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.
Development and validation of a risk model for predicting the risk of mild cognitive impairment among individuals of type 2 diabetes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training cohort | – | Other: TestsThe patients will be divided into the training and validation cohorts with a ratio of 7:3. The training cohort will be used to screen variables and construct the model. |
| Validation cohort | – | Other: TestsThe validation cohort will be used to validate the results obtained using the training cohort. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 diabetes
Key inclusion criteria (3 listed)
- Patients with type 2 diabetes mellitus ;
- Aged:40 -80 years ;
- Montreal Cognitive Assessment Scale (MoCA) scores 19 - 30;
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| TestsCognitive assessments and olfactory tests | Other | Training cohort, Validation cohort |
Primary outcome
The rate of mild cognitive impairment occurrence
Time frame: 1 year
The rate of Montreal Cognitive Assessment(MoCA) scores less than 26 points after 1 year's follow-up.
5 secondary outcomes
Glycaemic control measured by blood test.
Time frame: 1 day
Physical assessments.
Time frame: 1 day
Olfactory threshold test
Time frame: 1 day
Olfactory memory test
Time frame: 1 day
Montreal Cognitive Assessment (MoCA) score
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Background: PubMed 31221697Zhang 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.
- Background: PubMed 29500313Zhang 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.
- Background: PubMed 35263425Cheng 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.
- Derived from this study: PubMed 40303297Tian S, Wu T, Zhang Z, Lv S, Ji X, Zhao Z, Ma X, Wang J, Bi Y. Activation of central Angiotensin-(1-7)/Mas receptor alleviates synaptic damage in diabetes-associated cognitive impairment via modulating AKT/FOXO1/PACAP axis. Int J Biol Sci. 2025 Apr 9;21(6):2824-2842. doi: 10.7150/ijbs.99617. eCollection 2025.
- 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. This study is not recruiting at the moment.
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 Mellitus and Mild Cognitive Impairment, 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 28 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bi Yan, MD, PhD (+8602583106666, biyan@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of mild cognitive impairment occurrence (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05590442, which also lists 4 linked publications.
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 28 Mar 2024.