Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT05919927 |
Other study ID # |
TAUCH |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
June 7, 2018 |
Est. completion date |
December 30, 2024 |
Study information
Verified date |
June 2023 |
Source |
Tampere University Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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).
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.