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

Clalit Health Services

Status: Unknown

Conditions: Mild Cognitive Impairment; Diabetes Mellitus Type 2; Diabetes Mellitus Type 1

Treatments: Other: MoCa test

Study type: Interventional

Funder types: Other

Identifiers

NCT02545062

DM- MOCA- 1

Details and patient eligibility

About

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.

Full 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

Enrollment: 170 estimated patients

Sex: All

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

170 participants in 2 patient groups

group of type 1 and 2 diabetics

Experimental group

Description:

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.

Treatment:

Other: MoCa test

control group

Experimental group

Description:

The MoCa test will be done in a control group, no diabetics, that meets the inclusion criteria.

Treatment:

Other: MoCa test