Diabetes MellitusNIRS-DMNCT07491185
Effect of Glycemic Control on Intraoperative NIRS and Postoperative Recovery in Diabetic Patients
An observational study of Diabetes Mellitus and Glycemic Control, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate the effect of glycemic control level on intraoperative cerebral oxygenation measured by near-infrared spectroscopy (NIRS) and postoperative recovery in patients with diabetes mellitus undergoing elective urologic surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Glycemic Control, Cerebral Oxygenation
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients scheduled for elective urologic surgery under general anesthesia at a single tertiary university hospital will be included. The study population consists of patients with diabetes mellitus with different levels of glycemic control and non-diabetic control patients. Participants will be grouped according to preoperative HbA1c levels.
Who may be able to join
- Age ≥18 years
- Patients scheduled for elective urologic surgery under general anesthesia
- ASA physical status I-III
- Patients with diabetes mellitus or non-diabetic control patients
- Availability of preoperative HbA1c measurement
- Written informed consent obtained
Who cannot join
- Age <18 years
- ASA physical status >III
- Emergency surgery
- History of cerebrovascular disease or neurological disorder
- Previous brain or neurological surgery
- Inability to communicate or refusal to participate
- Intraoperative hemodynamic instability
- Inadequate NIRS monitoring data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ege University Faculty of Medicine Hospital
Izmir, 35100
Nursen Karaca, MD, +902323902142 ext. 2142, dr.nursenkaraca@hotmail.com
Işık Alper, Professor, +902323902140 ext. 2140, i.alper@yahoo.com
About this study
Official title: Effects of Intraoperative Near-Infrared Spectroscopy and Postoperative Recovery on Glycemic Control Levels in Patients With Diabetes Mellitus: A Prospective Study
This prospective observational study aims to evaluate the effect of glycemic control level on intraoperative cerebral oxygenation measured by near-infrared spectroscopy (NIRS) and postoperative recovery in patients with diabetes mellitus undergoing elective urologic surgery under general anesthesia.
Patients will be grouped according to HbA1c levels to assess the relationship between long-term glycemic control and intraoperative regional cerebral oxygen saturation, hemodynamic parameters, and postoperative recovery scores.
Read the detailed description
Diabetes mellitus is associated with increased perioperative morbidity and mortality, particularly in patients with poor long-term glycemic control. Elevated HbA1c levels may impair microcirculation and tissue oxygenation, which can affect cerebral perfusion during general anesthesia. Near-infrared spectroscopy (NIRS) is a non-invasive monitoring technique that allows continuous measurement of regional cerebral oxygen saturation and may help detect intraoperative hypoperfusion.
This prospective observational study is designed to investigate the relationship between glycemic control level and intraoperative cerebral oxygenation as well as postoperative recovery parameters in patients undergoing elective urologic surgery under general anesthesia. Patients will be divided into four groups according to preoperative HbA1c levels, including non-diabetic patients and diabetic patients with different levels of glycemic control.
Intraoperative monitoring will include standard hemodynamic parameters and bilateral regional cerebral oxygen saturation measured with near-infrared spectroscopy. The primary objective of the study is to determine whether poor glycemic control is associated with impaired cerebral oxygenation during anesthesia. Secondary objectives include evaluation of postoperative recovery parameters in relation to glycemic control level.
- Conditions
- Diabetes Mellitus, Glycemic Control, Cerebral Oxygenation, Anesthesia
- Keywords
- Diabetes Mellitus, Glycemic Control, Near-Infrared Spectroscopy, Postoperative Recovery
- Medical subject headings
- Diabetes Mellitus
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 |
|---|---|---|
| Control | Non-diabetic patients | |
| HbA1c 6-7 | Diabetic patients with HbA1c between 6% and 7% | |
| HbA1c 7-8 | Diabetic patients with HbA1c between 7% and 8% | |
| HbA1c >8 | Diabetic patients with HbA1c greater than 8% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Regional Cerebral Oxygen Saturation (rSO2)
Regional cerebral oxygen saturation measured intraoperatively using near-infrared spectroscopy and compared between groups according to HbA1c level.
Measured: Intraoperative period (from anesthesia induction to extubation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 Nov 2025
- Primary completionSep 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe 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
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nursen Karaca, Ege University
- Investigators
- NURSEN KARACA, MD, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491185
- Sponsor's protocol ID
- 25-10.2T/45
- Other IDs
- 25-10.2T/45
- Acronym
- NIRS-DM
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional regulations and privacy restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intraoperative Near-Infrared Spectroscopy and Postoperative Recovery on Glycemic Control Levels in Patients With Diabetes Mellitus: A Prospective Study
- ClinicalTrials.gov ID
- NCT07491185
- Acronym / sponsor ID
- NIRS-DM / 25-10.2T/45
- Conditions
- Diabetes Mellitus, Glycemic Control, Cerebral Oxygenation, Anesthesia
- Keywords
- Diabetes Mellitus, Glycemic Control, Near-Infrared Spectroscopy, Postoperative Recovery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 24 Mar 2026 (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 prospective observational study aims to evaluate the effect of glycemic control level on intraoperative cerebral oxygenation measured by near-infrared spectroscopy (NIRS) and postoperative recovery in patients with diabetes mellitus undergoing elective urologic surgery under general anesthesia.
Patients will be grouped according to HbA1c levels to assess the relationship between long-term glycemic control and intraoperative regional cerebral oxygen saturation, hemodynamic parameters, and postoperative recovery scores.
Detailed description
Diabetes mellitus is associated with increased perioperative morbidity and mortality, particularly in patients with poor long-term glycemic control. Elevated HbA1c levels may impair microcirculation and tissue oxygenation, which can affect cerebral perfusion during general anesthesia. Near-infrared spectroscopy (NIRS) is a non-invasive monitoring technique that allows continuous measurement of regional cerebral oxygen saturation and may help detect intraoperative hypoperfusion.
This prospective observational study is designed to investigate the relationship between glycemic control level and intraoperative cerebral oxygenation as well as postoperative recovery parameters in patients undergoing elective urologic surgery under general anesthesia. Patients will be divided into four groups according to preoperative HbA1c levels, including non-diabetic patients and diabetic patients with different levels of glycemic control.
Intraoperative monitoring will include standard hemodynamic parameters and bilateral regional cerebral oxygen saturation measured with near-infrared spectroscopy. The primary objective of the study is to determine whether poor glycemic control is associated with impaired cerebral oxygenation during anesthesia. Secondary objectives include evaluation of postoperative recovery parameters in relation to glycemic control level.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Non-diabetic patients |
| HbA1c 6-7 | – | –Diabetic patients with HbA1c between 6% and 7% |
| HbA1c 7-8 | – | –Diabetic patients with HbA1c between 7% and 8% |
| HbA1c >8 | – | –Diabetic patients with HbA1c greater than 8% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled for elective urologic surgery under general anesthesia at a single tertiary university hospital will be included. The study population consists of patients with diabetes mellitus with different levels of glycemic control and non-diabetic control patients. Participants will be grouped according to preoperative HbA1c levels.
Key inclusion criteria (6 listed)
- Age ≥18 years
- Patients scheduled for elective urologic surgery under general anesthesia
- ASA physical status I-III
- Patients with diabetes mellitus or non-diabetic control patients
- Availability of preoperative HbA1c measurement
Key exclusion criteria (8 listed)
- Age <18 years
- ASA physical status >III
- Emergency surgery
- History of cerebrovascular disease or neurological disorder
- Previous brain or neurological surgery
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
Change in Regional Cerebral Oxygen Saturation (rSO2)
Time frame: Intraoperative period (from anesthesia induction to extubation)
Regional cerebral oxygen saturation measured intraoperatively using near-infrared spectroscopy and compared between groups according to HbA1c level.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional regulations and privacy restrictions.
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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.
NURSEN KARACA, MD principal investigator
Ege 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 and Glycemic Control, run by Ege University at 1 site in Turkey (Türkiye).
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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 24 Mar 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nursen Karaca, MD (+902323902142 ext. 2142, dr.nursenkaraca@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Regional Cerebral Oxygen Saturation (rSO2) (time frame: Intraoperative period (from anesthesia induction to extubation)). 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 24 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.