Clinical trial NCT02545062: 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
Official title: Early Detection of Mild Cognitive Impairment in Young Diabetes Patients Using the MoCa Test
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus Type 1
Diabetes Mellitus Type 2
Mild Cognitive Impairment
Lead sponsor: Clalit Health Services
Sponsor class: OTHER
First posted: 2015-09-09
Enrollment: 170
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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: 1. 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.
2. Sign a consent form.
3. 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
4. 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.
5. 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

Eligibility criteria: 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
* 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

Primary outcomes:
measure: The differences between the MoCa test score in diabetics and in a control group of non diabetics
timeFrame: 1 year
Secondary outcomes:
measure: The relation between the MoCa test score and glycemic control, in terms of HA1C value, in the past year before recruitment
timeFrame: 1 year
measure: The relation between the MoCa test score and the presence of microvascular complications, retinopathy, polyneuropathy and nephropathy
timeFrame: 1 year
measure: 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
timeFrame: 1year
Other outcomes:
Locations:
city: Nes Tziona
country: Israel
facility: Viviana Ostrovsky
Study officials:
affiliation: Clalit Medical Service
name: Joel JS Singer, MD
role: STUDY_DIRECTOR
References: