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
Early Detection of Mild Cognitive Impairment in Young Diabetes Patients Using the MoCa Test
1 other identifier
interventional
170
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 23, 2015
CompletedFirst Posted
Study publicly available on registry
September 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedSeptember 11, 2015
September 1, 2015
2.3 years
August 23, 2015
September 10, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
The differences between the MoCa test score in diabetics and in a control group of non diabetics
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
1 year
The relation between the MoCa test score and the presence of microvascular complications, retinopathy, polyneuropathy and nephropathy
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
1year
Study Arms (2)
group of type 1 and 2 diabetics
EXPERIMENTALA 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
EXPERIMENTALThe MoCa test will be done in a control group, no diabetics, that meets the inclusion criteria.
Interventions
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.
Eligibility Criteria
You may qualify if:
- type 1 and 2 diabetes meIlitus
- to 55 years old
- up to 15 years of diabetes disease duration
- fluent speech and read hebrew's language only
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Viviana Ostrovsky
Nes Tziona, Israel, 7404964, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Joel JS Singer, MD
Clalit Medical Service
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. (MD) (specialist in Internal Medicine and Endocrinology and Diabetes)
Study Record Dates
First Submitted
August 23, 2015
First Posted
September 9, 2015
Study Start
May 1, 2014
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
September 11, 2015
Record last verified: 2015-09