Early Detection of Mild Cognitive Impairment in Young Diabetes Patients Using the MoCa Test
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Clalit Health Services
- Enrollment
- 170
- Locations
- 2
- Primary Endpoint
- The differences between the MoCa test score in diabetics and in a control group of non diabetics
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •not meeting the inclusion criteria
- •psychiatric disease
- •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
Outcomes
Primary Outcomes
The differences between the MoCa test score in diabetics and in a control group of non diabetics
Time Frame: 1 year
Secondary Outcomes
- 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)
Investigators
Viviana Ostrovsky
Dr. (MD) (specialist in Internal Medicine and Endocrinology and Diabetes)
Clalit Health Services