DementiaNCT01830998
Early Detection of Cognitive Dysfunction in Diabetes
An observational study of Dementia and DM, run by Wuhan General Hospital of Guangzhou Military Command at 3 sites in China.
Trial summary
The rate of cognitive decline due to ageing is increased 1.5-fold to 2.0-fold in individuals with type 2 diabetes.There are no established specific treatment measures to prevent or ameliorate cognitive impairments in patients with diabetes. we want to detecte early clinical dementia in diabete. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- How many people
- 400 participants
- Where
- 3 sitesChina
- Study dates
- Jan 2012to Dec 2014
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with type 2 diabetes
Who may be able to join
- Patients with type 2 diabetes(Age>50 years)
Who cannot join
- with stroke or other complications.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 2 recruiting
- Recruiting
Wuhan general hospital of Guangzhou Command
Wuhan, Hubei, 430070
xu zhi peng, doctor, 13871168392, xzhp14@sohu.com
- Enrolling by invitation
tongji Medical University
Wuhan, Hubei, 430074
- Active, not recruiting
Wuhan general hospital of Guangzhou command
Wuhan,chongqing, Hubei, 430070
About this study
Official title: Study of Cognitive Dysfunction and Diabetes
The rate of cognitive decline due to ageing is increased 1.5-fold to 2.0-fold in individuals with type 2 diabetes.There are no established specific treatment measures to prevent or ameliorate cognitive impairments in patients with diabetes. we want to detecte early clinical dementia in diabete.
Read the detailed description
Clinically relevant cognitive decrements in relation to diabetes mainly occur during two crucial periods in life: the period of brain development in childhood, and the period when the brain undergoes neurodegenerative changes associated with ageing.Potential leads for treatment are to optimise glycaemic control and avoid and treat vascular risk factors.we want to detecte early clinical dementia in diabete by MMSE and Olfactory function.
- Keywords
- Dementia, Olfactory
- Medical subject headings
- Dementia, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| control,MCI, Olfactory dsfunction | There are different groups:control,MCI, Olfactory dsfunction. | |
| control, MCI | control and MCI group.Glycaemic control | |
| control and MCI | treatment and without treatment | |
| MCI and Olfactory function | observation between MCI and Olfactory function groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMSE Olfactory function dementia
MMSE,Olfactory function and PET(fMRI) were observed.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startJan 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan General Hospital of Guangzhou Military Command
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhipeng xu, Wuhan General Hospital of Guangzhou Military Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830998
- Sponsor's protocol ID
- 20130401
- Status last verified
- Dec 2014
- First submitted
- 1 Apr 2013
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Cognitive Dysfunction and Diabetes
- ClinicalTrials.gov ID
- NCT01830998
- Acronym / sponsor ID
- 20130401
- Keywords
- Dementia, Olfactory
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Wuhan General Hospital of Guangzhou Military CommandUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 12 Apr 2013 (estimated)
- 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.
The rate of cognitive decline due to ageing is increased 1.5-fold to 2.0-fold in individuals with type 2 diabetes.There are no established specific treatment measures to prevent or ameliorate cognitive impairments in patients with diabetes. we want to detecte early clinical dementia in diabete.
Detailed description
Clinically relevant cognitive decrements in relation to diabetes mainly occur during two crucial periods in life: the period of brain development in childhood, and the period when the brain undergoes neurodegenerative changes associated with ageing.Potential leads for treatment are to optimise glycaemic control and avoid and treat vascular risk factors.we want to detecte early clinical dementia in diabete by MMSE and Olfactory function.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control,MCI, Olfactory dsfunction | – | –There are different groups:control,MCI, Olfactory dsfunction. |
| control, MCI | – | –control and MCI group.Glycaemic control |
| control and MCI | – | –treatment and without treatment |
| MCI and Olfactory function | – | –observation between MCI and Olfactory function groups. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 2 diabetes
Key inclusion criteria (1 listed)
- Patients with type 2 diabetes(Age>50 years)
Key exclusion criteria (1 listed)
- with stroke or other complications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MMSE Olfactory function dementia
Time frame: 2 years
MMSE,Olfactory function and PET(fMRI) were observed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2014.
Related trials for Dementia
Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
Active, not recruiting
Primary Care Detection of Cognitive Impairment Leveraging Health & Consumer Technologies in Underserved Communities: The MyCog Trial
Dementia, Cognitive Impairment
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
OCT-Angiography and Adaptive Optics in Patients With Memory Impairment
Amnesia, Alzheimer Disease
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and DM, run by Wuhan General Hospital of Guangzhou Military Command at 3 sites 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 1 inclusion and 1 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 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 xuzhipeng Wuqiang lihonghua, doctor (13871168392, 21823074@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMSE Olfactory function dementia (time frame: 2 years). 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 10 Dec 2014.