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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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ClinicalTrials.gov Identifier: NCT02545062
Recruitment Status : Unknown
Verified September 2015 by Viviana Ostrovsky, Clalit Health Services.
Recruitment status was:  Recruiting
First Posted : September 9, 2015
Last Update Posted : September 11, 2015
Sponsor:
Information provided by (Responsible Party):
Viviana Ostrovsky, Clalit Health Services

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 1 Diabetes Mellitus Type 2 Mild Cognitive Impairment Other: MoCa test Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Early Detection of Mild Cognitive Impairment in Young Diabetes Patients Using the MoCa Test
Study Start Date : May 2014
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: group of type 1 and 2 diabetics

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.

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.

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




Primary Outcome Measures :
  1. The differences between the MoCa test score in diabetics and in a control group of non diabetics [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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 ]
  2. The relation between the MoCa test score and the presence of microvascular complications, retinopathy, polyneuropathy and nephropathy [ Time Frame: 1 year ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02545062


Contacts
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Contact: Viviana VO Ostrovsky, MD +972504402029 vivianaos@clalit.org.il

Locations
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Israel
Viviana Ostrovsky Recruiting
Nes Tziona, Israel, 7404964
Contact: Viviana VO Ostrovsky, MD    +972503265303    vivianaos@clalit.org.il   
Sponsors and Collaborators
Clalit Health Services
Investigators
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Study Director: Joel JS Singer, MD Clalit Medical Service
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Responsible Party: Viviana Ostrovsky, Dr. (MD) (specialist in Internal Medicine and Endocrinology and Diabetes), Clalit Health Services
ClinicalTrials.gov Identifier: NCT02545062    
Other Study ID Numbers: DM- MOCA- 1
First Posted: September 9, 2015    Key Record Dates
Last Update Posted: September 11, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Cognitive Dysfunction
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Autoimmune Diseases
Immune System Diseases