Diabetes and Cognitive Functions in Middle Age

Diabetes Mellitus, Type 2 Clinical Trial

— DBC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05919927
• Other study ID #: TAUCH
• Status: Active, not recruiting
• 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
• 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 30, 2024
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

Inclusion Criteria:

• type II diabetes, age between 35-65 years

Exclusion Criteria:

• hypothyreosis, previous neurological diseases

Related Conditions & MeSH terms

• Cognitive Impairment
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hyperglycemia
• Hypoglycemia
• Mood

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (2)

Lead Sponsor	Collaborator
Tampere University Hospital	Tampere University

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wechsler Adult Intelligence Scale-test	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.	1 day.
Primary	Continuous Performance test	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.	1 day.
Primary	Rey-Osterrieth Complex Figure test	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.	1 day.
Primary	Sum score of the Z-scores of the performed standardized neuropsychological tests	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.	1 day.