Diabetes Mellitus, Type 2DBCNCT05919927
Diabetes and Cognitive Functions in Middle Age
An observational study of Diabetes Mellitus, Type 2 and Cognitive Impairment, run by Tampere University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Cognitive Impairment, Hyperglycemia
- How many people
- 120 participants
- Where
- 1 siteFinland
- Study dates
- 7 Jun 2018to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Type II diabetes patients and healthy controls
Who may be able to join
- type II diabetes, age between 35-65 years
Who cannot join
- hypothyreosis, previous neurological diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Type II Diabetes on Cognitive Functions in Middle-aged Patients
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).
Read the 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.
- Medical subject headings
- Diabetes Mellitus, Type 2, Cognitive Dysfunction, Hyperglycemia, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Type II diabetes patients | Neuropsychological examination is done and medical information is gathered from the medical records. | |
| Healthy controls | Neuropsychological examination, medical examination and laboratory tests. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day.
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.
Measured: 1 day.
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.
Measured: 1 day.
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.
Measured: 1 day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start7 Jun 2018
- Primary completion31 Dec 2022
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University
- Responsible party
- Sponsor
- Investigators
- Mervi Jehkonen, PhD, Principal investigator, Tampere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919927
- Sponsor's protocol ID
- TAUCH
- Acronym
- DBC
- Status last verified
- Jun 2023
- First submitted
- 7 Nov 2016
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Type II Diabetes on Cognitive Functions in Middle-aged Patients
- ClinicalTrials.gov ID
- NCT05919927
- Acronym / sponsor ID
- DBC / TAUCH
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Tampere University
- Study start
- 7 Jun 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type II diabetes patients | – | –Neuropsychological examination is done and medical information is gathered from the medical records. |
| Healthy controls | – | –Neuropsychological examination, medical examination and laboratory tests. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Type II diabetes patients and healthy controls
Key inclusion criteria (1 listed)
- type II diabetes, age between 35-65 years
Key exclusion criteria (1 listed)
- hypothyreosis, previous neurological diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
Related trials for Diabetes Mellitus, Type 2
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mervi Jehkonen, PhD principal investigator
Tampere University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Cognitive Impairment, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wechsler Adult Intelligence Scale-test (time frame: 1 day.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.