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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

Primary Purpose

Diabetes Mellitus Type 1, Diabetes Mellitus Type 2, Mild Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
MoCa test
Sponsored by
Clalit Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetes Mellitus Type 1

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Viviana OstrovskyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

group of type 1 and 2 diabetics

control group

Arm 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.

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

Outcomes

Primary Outcome Measures

The differences between the MoCa test score in diabetics and in a control group of non diabetics

Secondary Outcome Measures

The relation between the MoCa test score and glycemic control, in terms of HA1C value, in the past year before recruitment
The relation between the MoCa test score and the presence of microvascular complications, retinopathy, polyneuropathy and nephropathy
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

Full Information

First Posted
August 23, 2015
Last Updated
September 10, 2015
Sponsor
Clalit Health Services
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1. Study Identification

Unique Protocol Identification Number
NCT02545062
Brief Title
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

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clalit Health Services

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 1, Diabetes Mellitus Type 2, Mild Cognitive Impairment

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group of type 1 and 2 diabetics
Arm Type
Experimental
Arm 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.
Arm Title
control group
Arm Type
Experimental
Arm Description
The MoCa test will be done in a control group, no diabetics, that meets the inclusion criteria.
Intervention Type
Other
Intervention Name(s)
MoCa test
Intervention Description
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.
Primary Outcome Measure Information:
Title
The differences between the MoCa test score in diabetics and in a control group of non diabetics
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The relation between the MoCa test score and glycemic control, in terms of HA1C value, in the past year before recruitment
Time Frame
1 year
Title
The relation between the MoCa test score and the presence of microvascular complications, retinopathy, polyneuropathy and nephropathy
Time Frame
1 year
Title
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
Time Frame
1year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Viviana VO Ostrovsky, MD
Phone
+972504402029
Email
vivianaos@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel JS Singer, MD
Organizational Affiliation
Clalit Medical Service
Official's Role
Study Director
Facility Information:
Facility Name
Viviana Ostrovsky
City
Nes Tziona
ZIP/Postal Code
7404964
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Viviana VO Ostrovsky, MD
Phone
+972503265303
Email
vivianaos@clalit.org.il

12. IPD Sharing Statement

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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

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