Diabetes Mellitus, Type 2NCT04410419
Carbohydrate Loading and Diabetes in Colorectal Surgery
A study testing Pre-operative carbohydrate drink in people with Diabetes Mellitus, Type 2 and Surgery, run by University of Alberta at 1 site in Canada.
Trial summary
The goal of this study is to evaluate the feasibility of conducting a large study that would assess the safety of carbohydrate drinks (i.e. juice) prior to elective colorectal surgery in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Surgery, Surgery--Complications
- What is being tested?
- Pre-operative carbohydrate drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2018to 31 Dec 2024
- 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 (>=18 years of age) patients with an established diagnosis of type 2 diabetes mellitus undergoing elective colorectal surgery at the University of Alberta Hospital, the Grey Nuns Hospital, the Royal Alexandra Hospital or the Misericordia Hospital will be eligible. Only patients treated with diet or oral hypoglycemic agents will be included.
Who cannot join
- Subjects <18 years of age, and those on insulin therapy preoperatively will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Individuals With Diabetes Undergoing Elective Colorectal Surgery, Is Carbohydrate Loading Preoperatively Safe? A Pilot Randomized Controlled Trial
The goal of this study is to evaluate the feasibility of conducting a large study that would assess the safety of carbohydrate drinks (i.e. juice) prior to elective colorectal surgery in patients with type 2 diabetes.
Traditionally, prior to surgeries involving a general anesthetic, patients have been told not to eat or drink anything after midnight due to the risk of aspiration. More recent research have shown that it is safe to have clear fluids up to 2 hours before an operation and this is reflected in the current anesthesia clinical guidelines. Moreover, it has been shown that subjecting patients to a state of starvation causes stress on the body that may lead to complications such as poor wound healing, infections, and delayed return to bowel function. A sugar drink before surgery has been shown to be beneficial and can lead to decreased complication rates and decreased length of stay after surgery.
Read more
However, it is currently not known if it is safe for patients with type 2 diabetes to have a sugar drink before their surgery since they have trouble processing sugars and a subset of patients with diabetes are at increased risk of aspiration due to delayed stomach emptying.
This feasibility study is designed to answer the question of whether a large scale trial can be conducted examining the benefits of a pre-operative sugar drink in patients with type 2 diabetes.
- Conditions
- Diabetes Mellitus, Type 2, Surgery, Surgery--Complications
- Being tested
- Pre-operative carbohydrate drink
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-operative carbohydrate drinkDietary supplement
Carbohydrate drink containing 40g of carbohydrate to be consumed three hours prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Standard care for patients with diabetes pre-operatively . |
| Carbohydrate drink | Experimental | Carbohydrate drink containing 40g of carbohydrate to be consumed three hours prior to surgery Receives: Dietary Supplement: Pre-operative carbohydrate drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference of preoperative glucose between the two groups
Examined in a non-inferiority fashion with NI margin set as 2mmol/L
Measured: Pre-operative
Secondary outcomes (6)
Composite outcome of diabetes-related complications
hypoglycemia, DKA, cancellation of surgery, ketosis or perioperative aspiration
Measured: Within 30 days of surgery or to discharge
length of stay
How long the patient stays in hospital after surgery in days
Measured: Within 30 days of surgery or to discharge
Surgical site infection
Whether a wound infection is noted in hospital
Measured: Within 30 days of surgery or to discharge
Postoperative complications using the Clavien Dindo scale
A composite measure of post-operative complications stratified based on the Clavien Dindo scale from 1-5 with increasing severity from 1 to 5.
Measured: Within 30 days of surgery or to discharge
Post-operative serum blood glucose concentration
Serum blood glucose compiled on a daily basis
Measured: Within 30 days of surgery or to discharge
Rate of peri-operative insulin use
Whether insulin or an insulin infusion in the peri-operative period is used
Measured: Within 30 days of surgery or to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start1 Mar 2018
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410419
- Sponsor's protocol ID
- Carbs Drink in Colorectal
- Status last verified
- Aug 2025
- First submitted
- 22 May 2020
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Individuals With Diabetes Undergoing Elective Colorectal Surgery, Is Carbohydrate Loading Preoperatively Safe? A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04410419
- Acronym / sponsor ID
- Carbs Drink in Colorectal
- Conditions
- Diabetes Mellitus, Type 2, Surgery, Surgery--Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 1 Jun 2020 (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.
The goal of this study is to evaluate the feasibility of conducting a large study that would assess the safety of carbohydrate drinks (i.e. juice) prior to elective colorectal surgery in patients with type 2 diabetes.
Traditionally, prior to surgeries involving a general anesthetic, patients have been told not to eat or drink anything after midnight due to the risk of aspiration. More recent research have shown that it is safe to have clear fluids up to 2 hours before an operation and this is reflected in the current anesthesia clinical guidelines. Moreover, it has been shown that subjecting patients to a state of starvation causes stress on the body that may lead to complications such as poor wound healing, infections, and delayed return to bowel function. A sugar drink before surgery has been shown to be beneficial and can lead to decreased complication rates and decreased length of stay after surgery.
However, it is currently not known if it is safe for patients with type 2 diabetes to have a sugar drink before their surgery since they have trouble processing sugars and a subset of patients with diabetes are at increased risk of aspiration due to delayed stomach emptying.
This feasibility study is designed to answer the question of whether a large scale trial can be conducted examining the benefits of a pre-operative sugar drink in patients with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Standard care for patients with diabetes pre-operatively . |
| Carbohydrate drink | Experimental | Dietary Supplement: Pre-operative carbohydrate drinkCarbohydrate drink containing 40g of carbohydrate to be consumed three hours prior to surgery |
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 (>=18 years of age) patients with an established diagnosis of type 2 diabetes mellitus undergoing elective colorectal surgery at the University of Alberta Hospital, the Grey Nuns Hospital, the Royal Alexandra Hospital or the Misericordia Hospital will be eligible. Only patients treated with diet or oral hypoglycemic agents will be included.
Key exclusion criteria (1 listed)
- Subjects <18 years of age, and those on insulin therapy preoperatively will be excluded.
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 |
|---|---|---|
| Pre-operative carbohydrate drinkCarbohydrate drink containing 40g of carbohydrate to be consumed three hours prior to surgery | Dietary supplement | Carbohydrate drink |
Primary outcome
Mean difference of preoperative glucose between the two groups
Time frame: Pre-operative
Examined in a non-inferiority fashion with NI margin set as 2mmol/L
6 secondary outcomes
Composite outcome of diabetes-related complications
Time frame: Within 30 days of surgery or to discharge
length of stay
Time frame: Within 30 days of surgery or to discharge
Surgical site infection
Time frame: Within 30 days of surgery or to discharge
Postoperative complications using the Clavien Dindo scale
Time frame: Within 30 days of surgery or to discharge
Post-operative serum blood glucose concentration
Time frame: Within 30 days of surgery or to discharge
Rate of peri-operative insulin use
Time frame: Within 30 days of surgery or to discharge
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 Aug 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-operative carbohydrate drink in people with Diabetes Mellitus, Type 2 and Surgery, run by University of Alberta at 1 site in Canada.
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: finished, as of the sponsor's last update on 21 Aug 2025. 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 Canada. 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?
Mean difference of preoperative glucose between the two groups (time frame: Pre-operative). 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 Aug 2025.