DiabetesShoGR-SurgNCT06334068
SHOrt-term Glycemic Control for Reducing Post-SURGical Complications
A study testing Standard-of-care group in people with Diabetes and Uncontrolled Diabtetes, run by Mansoura University at 1 site in Egypt.
Trial summary
Perioperative dysglycemia-hyperglycemia, hypoglycemia, and glycemic variability-is associated with an increased risk for adverse outcomes. Several studies have reported the association between elevated preoperative HbA1c and postoperative complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Uncontrolled Diabtetes
- What is being tested?
- Standard-of-care group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteEgypt
- Study dates
- 8 May 2024to 23 Apr 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all adult diabetic patients (≥18 years) of either sex scheduled for major abdominal surgery (estimated operative time is > 2 hours) with Hb A1c ≥7.5% (58 mmol/mol).
Who cannot join
- Patients < 18 years
- Emergency Surgery
- Elective surgery that can be postponed safely till glycemic control
- Hb A1c < 7.5%
- Pregnant patients
- Patient Refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-term Glycemic Control in Patients With Uncontrolled Diabetes Mellitus Before Major Abdominal Surgery for Reducing Morbidity and Mortality: A Randomized Controlled Trial
Perioperative dysglycemia-hyperglycemia, hypoglycemia, and glycemic variability-is associated with an increased risk for adverse outcomes. Several studies have reported the association between elevated preoperative HbA1c and postoperative complications.
There are no studies that confirm that postponing elective surgery improves patient outcomes. Likewise, no prospective trials have studied whether short-term glycemic control reduces postoperative complications and unnecessary patient delays in elective surgeries.
Consequently, this randomized controlled trial aimed to investigate the effects of short-term glycemic control before major abdominal surgery on postoperative morbidity and mortality.
Read the detailed description
Despite the limitations of measurements of HbA1c, guidelines for perioperative glycemic management suggest delaying elective surgery if HbA1c exceeds certain levels (7-8.5%) (Joshi et al., 2010; CPOC, 2022). However, no studies confirm that postponing elective surgery improves patient outcomes. Likewise, no prospective trials have studied whether short-term glycemic control reduces postoperative complications and unnecessary patient delays in elective surgeries (Duggan et al., 2017).
Consequently, this randomized controlled trial aimed to investigate the effects of short-term glycemic control before major abdominal surgery on postoperative morbidity and mortality. The study hypothesis is that in diabetic patients who are presenting for non-cardiac non-elective surgery and whose HbA1c is ≥7.5% (≥58 mmol/mol), short-term glycemic control would improve outcome compared to standard-of-care, as measured with days-at-home at 30 postoperative days (DAH-30).
The current study aims to detect the value of short-term glycemic control in uncontrolled diabetic patients (preoperative HbA1c ≥7.5% [≥58 mmol/mol]) for reducing postoperative morbidity and mortality.
The patients in the preoperative anesthesia clinic will be randomized into one of the upcoming groups:
- Short-term glycemic control group: Patients will be admitted to the hospital for 2-3 days before surgery. During this pilot study, patients will be admitted to the intermediate care unit to monitor and control preoperative blood glucose. We aim to maintain moderate glucose control (140 - 180 mg/dl) using basal-bolus insulin protocol plus correctional doses as needed.
- Standard-of-care group: Patients will be admitted the day before surgery with the usual patient treatment.
In both groups, diabetic drugs will be managed per local protocol.
- Conditions
- Diabetes, Uncontrolled Diabtetes
- Being tested
- Short-term glycemic control group, Standard-of-care group
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-term glycemic control groupOther
Also called Active Intervention
Patients will be admitted to the hospital for 2-3 days before surgery. During this pilot study, patients will be admitted to the intermediate care unit to monitor and control preoperative blood glucose. We aim to maintain moderate glucose control (140-180 mg/dl) using the basal-bolus insulin protocol, plus correctional doses as needed.
Standard-of-care groupOther
Also called Control group
Patients will be admitted the day before surgery with the usual patient treatment.
| Study group | Role | What they receive |
|---|---|---|
| Short-term glycemic control group | Experimental | Patients will be admitted to the hospital for 2-3 days before surgery. During this pilot study, patients will be admitted to the intermediate care unit to monitor and control preoperative blood glucose. We aim to maintain moderate glucose control (140-180 mg/dl) using the basal-bolus insulin protocol, plus correctional doses as needed. Receives: Other: Short-term glycemic control group |
| Standard-of-care group | Active comparator | Patients will be admitted the day before surgery with the usual patient treatment. Receives: Other: Standard-of-care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days at home after surgery (DAH-30).
Continuous outcome as the number of days over the 30 days after surgery.
Measured: 30 days after surgery
Secondary outcomes (7)
Loss of follow-up after surgery
Incidence (yes/no) outcome
Measured: 30 days after Surgery
Loss of follow up after the clinic preoperative assessment
incidence (yes/no) outcome
Measured: 30 days after initial assessment
30-day mortality
incidence (yes/no) outcome
Measured: 30 days after surgery
Length of hospital stay
continuous outcome: number of days untill discharge from hospital after surgery
Measured: 30 days after surgery
incidence of postoperative complications
according to the comprehensive complications index (Kalt et al., 2023)
Measured: 30 days after surgery
Quality of Recovery15 (QoR-15)
a score of 15 items
Measured: after 24 hours of surgery
clinic-to-admission and clinic-to-surgery intervals
The time interval between the preoperative anesthesia clinic and admission or surgery in days, respectively.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start8 May 2024
- Primary completion23 Feb 2025
- Study completion23 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients in the preoperative anesthesia clinic are divided into one of the following groups: 1. Short-term glycemic control group: Patients will be admitted to the hospital for 2-3 days before surgery. During this pilot study, patients will be admitted to the intermediate care unit to monitor and control preoperative blood glucose. We aim to maintain moderate glucose control (140 - 180 mg/dl) using basal-bolus insulin protocol plus correctional doses as needed. 2. Standard-of-care group: Patients will be admitted the day before surgery with the usual patient treatment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moataz M Emara, MD, EDAIC, Principal investigator, Mansoura University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334068
- Sponsor's protocol ID
- MS.24.03.2725
- Acronym
- ShoGR-Surg
- Status last verified
- Jan 2026
- First submitted
- 21 Mar 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The anonymized individual data will be available with the principal investigator on reasonable request after IRB approval within two years of publication.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Glycemic Control in Patients With Uncontrolled Diabetes Mellitus Before Major Abdominal Surgery for Reducing Morbidity and Mortality: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06334068
- Acronym / sponsor ID
- ShoGR-Surg / MS.24.03.2725
- Conditions
- Diabetes, Uncontrolled Diabtetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 8 May 2024 (actual)
- Primary completion
- 23 Feb 2025 (actual)
- Study completion
- 23 Apr 2025 (actual)
- First posted
- 27 Mar 2024 (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.
Perioperative dysglycemia-hyperglycemia, hypoglycemia, and glycemic variability-is associated with an increased risk for adverse outcomes. Several studies have reported the association between elevated preoperative HbA1c and postoperative complications.
There are no studies that confirm that postponing elective surgery improves patient outcomes. Likewise, no prospective trials have studied whether short-term glycemic control reduces postoperative complications and unnecessary patient delays in elective surgeries.
Consequently, this randomized controlled trial aimed to investigate the effects of short-term glycemic control before major abdominal surgery on postoperative morbidity and mortality.
Detailed description
Despite the limitations of measurements of HbA1c, guidelines for perioperative glycemic management suggest delaying elective surgery if HbA1c exceeds certain levels (7-8.5%) (Joshi et al., 2010; CPOC, 2022). However, no studies confirm that postponing elective surgery improves patient outcomes. Likewise, no prospective trials have studied whether short-term glycemic control reduces postoperative complications and unnecessary patient delays in elective surgeries (Duggan et al., 2017).
Consequently, this randomized controlled trial aimed to investigate the effects of short-term glycemic control before major abdominal surgery on postoperative morbidity and mortality. The study hypothesis is that in diabetic patients who are presenting for non-cardiac non-elective surgery and whose HbA1c is ≥7.5% (≥58 mmol/mol), short-term glycemic control would improve outcome compared to standard-of-care, as measured with days-at-home at 30 postoperative days (DAH-30).
The current study aims to detect the value of short-term glycemic control in uncontrolled diabetic patients (preoperative HbA1c ≥7.5% [≥58 mmol/mol]) for reducing postoperative morbidity and mortality.
The patients in the preoperative anesthesia clinic will be randomized into one of the upcoming groups:
- Short-term glycemic control group: Patients will be admitted to the hospital for 2-3 days before surgery. During this pilot study, patients will be admitted to the intermediate care unit to monitor and control preoperative blood glucose. We aim to maintain moderate glucose control (140 - 180 mg/dl) using basal-bolus insulin protocol plus correctional doses as needed.
- Standard-of-care group: Patients will be admitted the day before surgery with the usual patient treatment.
In both groups, diabetic drugs will be managed per local protocol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The patients in the preoperative anesthesia clinic are divided into one of the following groups: 1. Short-term glycemic control group: Patients will be admitted to the hospital for 2-3 days before surgery. During this pilot study, patients will be admitted to the intermediate care unit to monitor and control preoperative blood glucose. We aim to maintain moderate glucose control (140 - 180 mg/dl) using basal-bolus insulin protocol plus correctional doses as needed. 2. Standard-of-care group: Patients will be admitted the day before surgery with the usual patient treatment.
| Arm | Type | Receives |
|---|---|---|
| Short-term glycemic control group | Experimental | Other: Short-term glycemic control groupPatients will be admitted to the hospital for 2-3 days before surgery. During this pilot study, patients will be admitted to the intermediate care unit to monitor and control preoperative blood glucose. We aim to maintain moderate glucose control (140-180 mg/dl) using the basal-bolus insulin protocol, plus correctional doses as needed. |
| Standard-of-care group | Active comparator | Other: Standard-of-care groupPatients will be admitted the day before surgery with the usual patient treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all adult diabetic patients (≥18 years) of either sex scheduled for major abdominal surgery (estimated operative time is > 2 hours) with Hb A1c ≥7.5% (58 mmol/mol).
Key exclusion criteria (6 listed)
- Patients < 18 years
- Emergency Surgery
- Elective surgery that can be postponed safely till glycemic control
- Hb A1c < 7.5%
- Pregnant patients
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 |
|---|---|---|
| Short-term glycemic control groupAlso: Active InterventionPatients will be admitted to the hospital for 2-3 days before surgery. During this pilot study, patients will be admitted to the intermediate care unit to monitor and control preoperative blood glucose. We aim to maintain moderate glucose control (140-180 mg/dl) using the basal-bolus insulin protocol, plus correctional doses as needed. | Other | Short-term glycemic control group |
| Standard-of-care groupAlso: Control groupPatients will be admitted the day before surgery with the usual patient treatment. | Other | Standard-of-care group |
Primary outcome
Number of days at home after surgery (DAH-30).
Time frame: 30 days after surgery
Continuous outcome as the number of days over the 30 days after surgery.
7 secondary outcomes
Loss of follow-up after surgery
Time frame: 30 days after Surgery
Loss of follow up after the clinic preoperative assessment
Time frame: 30 days after initial assessment
30-day mortality
Time frame: 30 days after surgery
Length of hospital stay
Time frame: 30 days after surgery
incidence of postoperative complications
Time frame: 30 days after surgery
Quality of Recovery15 (QoR-15)
Time frame: after 24 hours of surgery
clinic-to-admission and clinic-to-surgery intervals
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Yes. The anonymized individual data will be available with the principal investigator on reasonable request after IRB approval within two years of publication.
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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.
Moataz M Emara, MD, EDAIC principal investigator
Mansoura University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard-of-care group in people with Diabetes and Uncontrolled Diabtetes, run by Mansoura University at 1 site in Egypt.
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 6 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: finished, as of the sponsor's last update on 21 Jan 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of days at home after surgery (DAH-30). (time frame: 30 days after surgery). 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 21 Jan 2026.