Diabetes Mellitus Type 1NCT02545062
MoCa Test for the Early Detection of Mild Cognitive Impairment During Annual Assessment of Young Adults With Diabetes and in a Control Group Without Diabetes
A study testing MoCa test in people with Diabetes Mellitus Type 1 and Diabetes Mellitus Type 2, run by Clalit Health Services at 1 site in Israel.
Trial summary
T2D and cognitive impairment are two of the most common chronic condition found in persons 60 years and older. Diabetes type 2 increases with age and studies suggest that the diabetes is one of the risk factor for cognitive impairment and dementia. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus Type 1, Diabetes Mellitus Type 2, Mild Cognitive Impairment
- What is being tested?
- MoCa test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteIsrael
- Study dates
- May 2014to Aug 2016
- Phase
- Interventional
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- type 1 and 2 diabetes meIlitus
- 20 to 55 years old
- up to 15 years of diabetes disease duration
- fluent speech and read hebrew's language only
Who cannot join
- not meeting the inclusion criteria
- psychiatric disease
- dementia
- chronic use of alcohol or illegal drugs
- use of medication that can alter the attention or cognition of the participant
- active cardiovascular disease in the previous six months before the investigation
- oncology disease in the previous six months before the investigation
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Viviana Ostrovsky
Nes Tziona, Israel, 7404964
Viviana VO Ostrovsky, MD, +972503265303, vivianaos@clalit.org.il
About this study
Official title: Early Detection of Mild Cognitive Impairment in Young Diabetes Patients Using the MoCa Test
T2D and cognitive impairment are two of the most common chronic condition found in persons 60 years and older. Diabetes type 2 increases with age and studies suggest that the diabetes is one of the risk factor for cognitive impairment and dementia.
Although there is much recent research showing that diabetics at every age have more cognitive impairment and dementia than non-diabetics, relatively little attention has been paid to the implications of this complication in the management of T2D in terms of screening, prevention, education and treatment adherence.
Read more
There are now guidelines for periodic evaluation of patients with diabetes as early detection of complications of the disease, but so far there are no similar assessment and monitoring of cognitive function.
In this study the investigators examine cognitive function in young diabetic patients (from 20 to 55) using the MoCa test, that allows detection of mild cognitive impairment, and may be carried out during a visit, an annual advisory diabetes clinic.
Read the detailed description
- Patients on a routine visit to the diabetes clinic, who meet the inclusion criteria, will be recruited for the test. They will be given an explanation of the study and the questionnaire by the principal investigator.
- Sign a consent form.
- Performance and execution of MOCA test:
- Fingerstick blood glucose for pre-cognitive testing performed (to avoid testing any participant with a serum glucose < 70 mg/dl);
- In the presence of hypoglycemia, the participant should be given a snack and begin the test only after the glucose level rises. Alternatively delay executing the Test
- Details from the patient's file are registered, such as: duration of the disease, family history, presence of macro and micro vascular complications, lifestyle, years of education, and the results of relevant laboratory accuracy.
- For each patient a medical file is opened containing the initials and serial number of his research. All results are then encoded and analyzed anonymously
- Being tested
- MoCa test
- Medical subject headings
- Diabetes Mellitus, Type 1, 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.
MoCa testOther
The MoCa test is actually used for the screening of Mild Cognitive Impairment . It is a one page 30 points test that can be done in 10 minutes in a routine annual visit to the Diabetes Clinic. The MoCa assesses several cognitive domains, and it is available in hebrew language.
| Study group | Role | What they receive |
|---|---|---|
| group of type 1 and 2 diabetics | Experimental | A group of type 1 and 2 diabetes patients who meets the inclusion criteria will be done the MoCa test. A fingertip blood glucose will be made previous to the begin with the test in order to avoid doing it on a hypoglycemia event. The participants are instructed to do or respond the items in a organized manner. For each items there's a score. If the participant has 12 years of education or fewer, a point is added to his total score. At the end of the test the investigator will sum all sub items scores listed on the right side of the test paper. The maximum score is 30.
The MoCa test will be done in a control group, no diabetics, that meets the inclusion criteria. Receives: Other: MoCa test |
| control group | Experimental | The MoCa test will be done in a control group, no diabetics, that meets the inclusion criteria. Receives: Other: MoCa test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The differences between the MoCa test score in diabetics and in a control group of non diabetics
Measured: 1 year
Secondary outcomes (3)
The relation between the MoCa test score and glycemic control, in terms of HA1C value, in the past year before recruitment
Measured: 1 year
The relation between the MoCa test score and the presence of microvascular complications, retinopathy, polyneuropathy and nephropathy
Measured: 1 year
The relation between the MoCa test score and the presence of macrovascular complication, ischemic heart disease, non-fatal myocardial infarct, stable and unstable angina, heart failure, non-fatal stroke, peripheral vascular disease
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startMay 2014
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 1Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Viviana Ostrovsky, Clalit Health Services
- Investigators
- Joel JS Singer, MD, Study director, Clalit Medical Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545062
- Sponsor's protocol ID
- DM- MOCA- 1
- Status last verified
- Sep 2015
- First submitted
- 23 Aug 2015
- Last updated
- 11 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Mild Cognitive Impairment in Young Diabetes Patients Using the MoCa Test
- ClinicalTrials.gov ID
- NCT02545062
- Acronym / sponsor ID
- DM- MOCA- 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 9 Sep 2015 (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.
T2D and cognitive impairment are two of the most common chronic condition found in persons 60 years and older. Diabetes type 2 increases with age and studies suggest that the diabetes is one of the risk factor for cognitive impairment and dementia.
Although there is much recent research showing that diabetics at every age have more cognitive impairment and dementia than non-diabetics, relatively little attention has been paid to the implications of this complication in the management of T2D in terms of screening, prevention, education and treatment adherence.
There are now guidelines for periodic evaluation of patients with diabetes as early detection of complications of the disease, but so far there are no similar assessment and monitoring of cognitive function.
In this study the investigators examine cognitive function in young diabetic patients (from 20 to 55) using the MoCa test, that allows detection of mild cognitive impairment, and may be carried out during a visit, an annual advisory diabetes clinic.
Detailed description
- Patients on a routine visit to the diabetes clinic, who meet the inclusion criteria, will be recruited for the test. They will be given an explanation of the study and the questionnaire by the principal investigator.
- Sign a consent form.
- Performance and execution of MOCA test:
- Fingerstick blood glucose for pre-cognitive testing performed (to avoid testing any participant with a serum glucose < 70 mg/dl);
- In the presence of hypoglycemia, the participant should be given a snack and begin the test only after the glucose level rises. Alternatively delay executing the Test
- Details from the patient's file are registered, such as: duration of the disease, family history, presence of macro and micro vascular complications, lifestyle, years of education, and the results of relevant laboratory accuracy.
- For each patient a medical file is opened containing the initials and serial number of his research. All results are then encoded and analyzed anonymously
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group of type 1 and 2 diabetics | Experimental | Other: MoCa testA group of type 1 and 2 diabetes patients who meets the inclusion criteria will be done the MoCa test. A fingertip blood glucose will be made previous to the begin with the test in order to avoid doing it on a hypoglycemia event. The participants are instructed to do or respond the items in a organized manner. For each items there's a score. If the participant has 12 years of education or fewer, a point is added to his total score. At the end of the test the investigator will sum all sub items scores listed on the right side of the test paper. The maximum score is 30. The MoCa test will be done in a control group, no diabetics, that meets the inclusion criteria. |
| control group | Experimental | Other: MoCa testThe MoCa test will be done in a control group, no diabetics, that meets the inclusion criteria. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- type 1 and 2 diabetes meIlitus
- 20 to 55 years old
- up to 15 years of diabetes disease duration
- fluent speech and read hebrew's language only
Key exclusion criteria (7 listed)
- not meeting the inclusion criteria
- psychiatric disease
- dementia
- chronic use of alcohol or illegal drugs
- use of medication that can alter the attention or cognition of the participant
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 |
|---|---|---|
| MoCa testThe MoCa test is actually used for the screening of Mild Cognitive Impairment . It is a one page 30 points test that can be done in 10 minutes in a routine annual visit to the Diabetes Clinic. The MoCa assesses several cognitive domains, and it is available in hebrew language. | Other | control group, group of type 1 and 2 diabetics |
Primary outcome
The differences between the MoCa test score in diabetics and in a control group of non diabetics
Time frame: 1 year
3 secondary outcomes
The relation between the MoCa test score and glycemic control, in terms of HA1C value, in the past year before recruitment
Time frame: 1 year
The relation between the MoCa test score and the presence of microvascular complications, retinopathy, polyneuropathy and nephropathy
Time frame: 1 year
The relation between the MoCa test score and the presence of macrovascular complication, ischemic heart disease, non-fatal myocardial infarct, stable and unstable angina, heart failure, non-fatal stroke, peripheral vascular disease
Time frame: 1year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2015.
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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.
Joel JS Singer, MD study director
Clalit Medical Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MoCa test in people with Diabetes Mellitus Type 1 and Diabetes Mellitus Type 2, run by Clalit Health Services at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 11 Sep 2015. 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 Israel. 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 Viviana VO Ostrovsky, MD (+972504402029, vivianaos@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The differences between the MoCa test score in diabetics and in a control group of non diabetics (time frame: 1 year). 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 11 Sep 2015.