Clinical trial NCT05919927: Diabetes and Cognitive Functions in Middle Age
Official title: Effects of Type II Diabetes on Cognitive Functions in Middle-aged Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus, Type 2
Cognitive Impairment
Hyperglycemia
Hypoglycemia
Mood
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University
First posted: 2023-06-27
Enrollment: 120
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Type II diabetes patients and healthy controls

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.

Eligibility criteria: Inclusion Criteria:

* type II diabetes, age between 35-65 years

Exclusion Criteria:

* hypothyreosis, previous neurological diseases

Primary outcomes:
measure: Wechsler Adult Intelligence Scale-test
timeFrame: 1 day.
measure: Continuous Performance test
timeFrame: 1 day.
measure: Rey-Osterrieth Complex Figure test
timeFrame: 1 day.
measure: Sum score of the Z-scores of the performed standardized neuropsychological tests
timeFrame: 1 day.
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University
name: Mervi Jehkonen, PhD
role: PRINCIPAL_INVESTIGATOR
References: