Neurocognitive DisordersNCT04736277
HbA1c and Neurocognitive Disorders
An observational study of Neurocognitive Disorders and HbA1c, run by University of Thessaly at 1 site in Greece.
Trial summary
Preliminary evidence suggest a possible relationship between HbA1c and perioperative neurocognitive disorders (NCD). We are going to investigate whether the preoperative value of HbA1c in patients undergoing elective non-cardiac surgery under general anesthesia, are related with increased risk of perioperative NCD. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Neurocognitive Disorders, HbA1c
- What is being tested?
- Preoperative HbA1c
- How many people
- 288 participants
- Where
- 1 siteGreece
- Study dates
- 1 Dec 2015to 1 Nov 2021
- 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 45 to 80 years
- All sexes
- Adult, Older adult
Study population: - All patients 45 - 80 years old, ASA I-III undergoing elective general, urological, gynecological and orthopedic surgery under general anesthesia
Who may be able to join
- 1) 45 - 80 years
- 2) American Society of Anesthesiologists physical status I to III
- 3) elective general, urological, gynecological and orthopedic surgery under general anesthesia
- 4) native speakers of the Greek language
Who cannot join
- 1) refused to participate or sign the informed consent form
- 2) had undergone surgery or anesthesia within the last 30 days
- 3) had any prior or current history involving an affliction of the central nervous system
- 4) were diagnosed with severe cognitive decline based on the 16 - item Informant Questionnaire on Cognitive Decline (IQCODE - 16)
- 5) suffered from severe hearing or visual impairment
- 6) any psychiatric disorder
Show all 17Show fewer
- 7) had a score >5 in the Geriatric Depression Scale (GDS - 15)
- 8) or a score in females < 4 males < 2 in the Lawton - Brody Instrumental Activities of Daily Living Scale (I.A.D.L.)
- 9) reported alcohol consumption > 35 units/week
- 10) drug dependence
- 11) had undergone previous neuropsychological testing
- 12) Diabetes Mellitus type II with > 10 years of diagnosis
- 13) Diabetes Mellitus type I
- 14) Hemoglobin A1c (HbA1c) > 7.5%
- 15) suffered from hemodynamical instability (> 20% alterations of blood pressure perioperatively)
- 16) or desaturation (one or more events of SpO2 < 80% for more than 2 minutes) peri-operatively
- 17) or blood loss of more than one unit
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
University of Thessaly
Larissa, 41335
Eleni Arnaoutoglou, MD, PhD, +306974301352, earnaout@gmail.com
Maria Ntalouka, MD, PhD, +306973688099, maria.ntalouka@icloud.com
About this study
Official title: The Effect of HbA1c on Perioperative Neurocognitive Disorders in Patients Undergoing Elective Non-cardiac Surgery Under General Anesthesia.
Preliminary evidence suggest a possible relationship between HbA1c and perioperative neurocognitive disorders (NCD). We are going to investigate whether the preoperative value of HbA1c in patients undergoing elective non-cardiac surgery under general anesthesia, are related with increased risk of perioperative NCD.
Read the detailed description
It is estimated that approximately 10% of elderly undergoing surgery will develop cognitive changes perioperatively, while in some reports the incidence rises up to 80%. Despite the reported high prevalence of perioperative neurocognitive disorders (NCD), their exact etiology is still largely unknown.
Preliminary evidence suggest a possible relationship between HbA1c and perioperative neurocognitive disorders (NCD). We are going to investigate whether the preoperative value of HbA1c in patients undergoing elective non-cardiac surgery under general anesthesia, are related with increased risk of perioperative NCD.
- Conditions
- Neurocognitive Disorders, HbA1c
- Being tested
- Preoperative HbA1c
- Medical subject headings
- Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative HbA1cOther
Documentation of the preopetative HbA1c in patients undergoing noncardiac surgery under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Noncardiac surgery | Documentation of HbA1c in patients undergoing noncardiac surgery under general anesthesia Receives: Other: Preoperative HbA1c |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Neurocognitive Disorders assessed with CAM
Screening for POD assessed with CAM
Measured: 1st postoperative day
Incidence of Postoperative Neurocognitive Disorders with IQCODE-16
Screening for POCD with IQCODE-16
Measured: 10th postoperative day
Incidence of Postoperative Neurocognitive Disorders with IQCODE-16
Screening for POCD with IQCODE-16
Measured: 3 months postoperatively
Incidence of Postoperative Neurocognitive Disorders with IQCODE-16
Screening for POCD with IQCODE-16
Measured: 6 months postoperatively
Incidence of Postoperative Neurocognitive Disorders with IQCODE-16
Screening for POCD with IQCODE-16
Measured: 9 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start1 Dec 2015
- Primary completion1 Sep 2021
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive DisordersStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ioannina, Larissa University Hospital
- Responsible party
- Principal investigator, Elena Arnaoutoglou, University of Thessaly
- Investigators
- Eleni Arnaoutoglou, MD, PhD, Study chair, Professor of AnesthesiologyMaria Ntalouka, MD, PhD, Principal investigator, Consultant of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736277
- Sponsor's protocol ID
- HbA1c and NCD
- Status last verified
- Apr 2021
- First submitted
- 24 Oct 2020
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of HbA1c on Perioperative Neurocognitive Disorders in Patients Undergoing Elective Non-cardiac Surgery Under General Anesthesia.
- ClinicalTrials.gov ID
- NCT04736277
- Acronym / sponsor ID
- HbA1c and NCD
- Conditions
- Neurocognitive Disorders, HbA1c
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Collaborators
- University Hospital, Ioannina, Larissa University Hospital
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 3 Feb 2021 (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.
Preliminary evidence suggest a possible relationship between HbA1c and perioperative neurocognitive disorders (NCD). We are going to investigate whether the preoperative value of HbA1c in patients undergoing elective non-cardiac surgery under general anesthesia, are related with increased risk of perioperative NCD.
Detailed description
It is estimated that approximately 10% of elderly undergoing surgery will develop cognitive changes perioperatively, while in some reports the incidence rises up to 80%. Despite the reported high prevalence of perioperative neurocognitive disorders (NCD), their exact etiology is still largely unknown.
Preliminary evidence suggest a possible relationship between HbA1c and perioperative neurocognitive disorders (NCD). We are going to investigate whether the preoperative value of HbA1c in patients undergoing elective non-cardiac surgery under general anesthesia, are related with increased risk of perioperative NCD.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Noncardiac surgery | – | Other: Preoperative HbA1cDocumentation of HbA1c in patients undergoing noncardiac surgery under general anesthesia |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- - All patients 45 - 80 years old, ASA I-III undergoing elective general, urological, gynecological and orthopedic surgery under general anesthesia
Key inclusion criteria (4 listed)
- 1) 45 - 80 years
- 2) American Society of Anesthesiologists physical status I to III
- 3) elective general, urological, gynecological and orthopedic surgery under general anesthesia
- 4) native speakers of the Greek language
Key exclusion criteria (17 listed)
- 1) refused to participate or sign the informed consent form
- 2) had undergone surgery or anesthesia within the last 30 days
- 3) had any prior or current history involving an affliction of the central nervous system
- 4) were diagnosed with severe cognitive decline based on the 16 - item Informant Questionnaire on Cognitive Decline (IQCODE - 16)
- 5) suffered from severe hearing or visual impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative HbA1cDocumentation of the preopetative HbA1c in patients undergoing noncardiac surgery under general anesthesia | Other | Noncardiac surgery |
Primary outcome
Incidence of Postoperative Neurocognitive Disorders assessed with CAM
Time frame: 1st postoperative day
Screening for POD assessed with CAM
Incidence of Postoperative Neurocognitive Disorders with IQCODE-16
Time frame: 10th postoperative day
Screening for POCD with IQCODE-16
Incidence of Postoperative Neurocognitive Disorders with IQCODE-16
Time frame: 3 months postoperatively
Screening for POCD with IQCODE-16
Incidence of Postoperative Neurocognitive Disorders with IQCODE-16
Time frame: 6 months postoperatively
Screening for POCD with IQCODE-16
Incidence of Postoperative Neurocognitive Disorders with IQCODE-16
Time frame: 9 months postoperatively
Screening for POCD with IQCODE-16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Individual participant dataSharing planned: Undecided
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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.
Eleni Arnaoutoglou, MD, PhD study chair
Professor of Anesthesiology
Maria Ntalouka, MD, PhD principal investigator
Consultant of Anesthesiology
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 Neurocognitive Disorders and HbA1c, run by University of Thessaly at 1 site in Greece.
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 4 inclusion and 17 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 11 Oct 2021. 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 Greece. 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?
Contact Maria Ntalouka, MD, PhD (+306973688099, maria.ntalouka@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Neurocognitive Disorders assessed with CAM (time frame: 1st postoperative day). The study lists 5 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 11 Oct 2021; AzTrials last refreshed its copy on 2 Nov 2026.