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

Mild Cognitive Impairment Clinical Trial

Official title:

Early Detection of Mild Cognitive Impairment in Young Diabetes Patients Using the MoCa Test

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02545062
• Other study ID #: DM- MOCA- 1
• Status: Recruiting
• Phase: N/A
• First received: August 23, 2015
• Last updated: September 10, 2015
• Start date: May 2014
• Est. completion date: August 2016

Study information

• Verified date: September 2015
• Source: Clalit Health Services
• Contact: Viviana VO Ostrovsky, MD
• Phone: +972504402029
• Email: vivianaos[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical 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.

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cognition Disorders
• Diabetes Mellitus
• Diabetes Mellitus Type 1
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Mild Cognitive Impairment

Intervention

Other:
• MoCa test
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.

Locations

Country	Name	City	State
Israel	Viviana Ostrovsky	Nes Tziona

Sponsors (1)

Lead Sponsor	Collaborator
Clalit Health Services

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The differences between the MoCa test score in diabetics and in a control group of non diabetics		1 year	No
Secondary	The relation between the MoCa test score and glycemic control, in terms of HA1C value, in the past year before recruitment		1 year	No
Secondary	The relation between the MoCa test score and the presence of microvascular complications, retinopathy, polyneuropathy and nephropathy		1 year	No
Secondary	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	No