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Clinical Trials/NCT05919927
NCT05919927
Active, not recruiting
Not Applicable

Effects of Type II Diabetes on Cognitive Functions in Middle-aged Patients

Tampere University Hospital1 site in 1 country120 target enrollmentJune 7, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 2
Sponsor
Tampere University Hospital
Enrollment
120
Locations
1
Primary Endpoint
Sum score of the Z-scores of the performed standardized neuropsychological tests
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

This study will examine the effects of type II diabetes on cognitive functions and mood in middle-aged patients. In addition, the association between cognitive functions and glycemic controls is studied in patients. Sixty patients and sixty healthy controls will be recruited and assessed by a multiprofessional team (neuropsychologist, physician).

Detailed Description

Sixty patients with type 2 diabetes will be recruited from the Tampere Diabetes outpatient clinic. Inclusion criteria for the patients are type 2 diabetes diagnosis, diabetes medication and age 35-65. Exclusion criteria are type 1 diabetes, hypothyreosis, neurological or psychiatric disorder, substance abuse and serious diabetes complications. Sixty healthy control persons are recruited from the personnel and occupational health care. Exclusion criteria for controls are type 1 or 2 diabetes, hypothyreosis, neurological or psychiatric disease and substance abuse. A comprehensive neuropsychological assessment is made to all participants.The assessment consists of standardized neuropsychological tests, questionnaires and interview. Domains assessed include attention, executive functions, memory, information processing speed, general cognitive functioning, depressive symptoms, anxiety and fatigue. Medical information (such as glycated hemoglobin and blood pressure) from the patients is gathered from the medical records. Corresponding information from the control participants is gathered with medical examinations including laboratory tests. Informed consent is taken from all participants. This study will examine the difference in cognitive functions between healthy controls and middle-aged patients with type 2 diabetes. There is evidence from previous studies that type 2 diabetes is related to an increased risk of dementia, but the association between diabetes and cognition at younger ages is less studies. The difference in mood and fatigue is also studied between the groups. In addition, the association between glycated hemoglobin level and cognitive functions is examined in patients, as poor glycemic control has been implicated to impact on cognitive decline in previous studies. Finally, the association between history of hypoglycemic episodes and cognition is studied.

Registry
clinicaltrials.gov
Start Date
June 7, 2018
End Date
December 30, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • type II diabetes, age between 35-65 years

Exclusion Criteria

  • hypothyreosis, previous neurological diseases

Outcomes

Primary Outcomes

Sum score of the Z-scores of the performed standardized neuropsychological tests

Time Frame: 1 day.

Sum score of the Z-scores of the performed standardized neuropsychological tests (Wechsler Adult Intelligence Scale, Continuous Performance test and Rey-Osterrieth Complex Figure test). Average performances evaluated by the differences in these sum scores are compared between healthy controls and patients with type 2 diabetes using SPSS-program.

Wechsler Adult Intelligence Scale-test

Time Frame: 1 day.

Wechsler Adult Intelligence Scale-test and its z-score. Average performance differences in this cognitive test are compared between healthy controls and patients with type 2 diabetes using SPSS-program.

Rey-Osterrieth Complex Figure test

Time Frame: 1 day.

Rey-Osterrieth Complex Figure test and its z-score. Average performance differences in this cognitive test are compared between healthy controls and patients with type 2 diabetes using SPSS-program.

Continuous Performance test

Time Frame: 1 day.

Continuous Performance test and its z-score. Average performance differences in this cognitive test are compared between healthy controls and patients with type 2 diabetes using SPSS-program.

Study Sites (1)

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