Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05919927
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-27
First Post:
2016-11-07
Brief Title:
Diabetes and Cognitive Functions in Middle Age
Sponsor:
Tampere University Hospital
Organization:
Tampere University Hospital
Study Overview
Official Title:
Effects of Type II Diabetes on Cognitive Functions in Middle-aged Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DBC
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 participantsThe 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
A comprehensive neuropsychological assessment is made to all participantsThe 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None