Diabetes Mellitus, Type 2NCT04495114
Pre-operative Carbohydrate Loading Patients With Diabetes Undergoing Elective Colorectal Surgery
A study testing 40g carbohydrate load (Apple juice) in people with Diabetes Mellitus, Type 2, run by University of Alberta at 1 site in Canada.
Trial summary
Goal 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
- What is being tested?
- 40g carbohydrate load (Apple juice)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteCanada
- Study dates
- 31 Aug 2017to 31 Mar 2020
- 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
- Type 2 diabetes, non-insulin dependent.
- Elective colorectal surgery patient at the University of Alberta Hospital, Grey Nuns Hospital, Misericordia Hospital, Foothills Hospital, or Royal Alexandra Hospital.
Who cannot join
- Insulin dependent type 2 diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Goal 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 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.
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 to aspiration due to delayed gastric emptying.
Read the detailed description
Fasting prior to the administration of a general anesthetic has been the standard of peri-operative care for many years. The refrain of "nothing to eat or drink after midnight" has become synonymous with surgery for both clinicians and the general public. The rationale behind this practice has been to reduce the risk of regurgitation of gastric contents. In addition, this instruction is straightforward for patients and ancillary staff, and allows for easy alteration of the order of cases on the operative list. Despite the widespread nature of this practice, a 2003 Cochrane review attempted to define the optimum duration of fasting, type of fasting, and volume of intake permitted and concluded that there was no evidence to suggest a shortened fluid fast resulted in an increased risk of aspiration, regurgitation, or morbidity in healthy patients.
Pre-operative fasting leads to insulin resistance and metabolic stresses. More recently it has been suggested that a preoperative carbohydrate loading may alleviate some deleterious effects of this fast. This strategy, combined with a number of others, have been recently introduced in many Enhanced Recovery After Surgery (ERAS) programs, that have led to improved postoperative pain, faster restoration of GI function, decreased LOS and decreased complication rate after colon surgery.
Type 2 diabetes is a disease of impaired glucose tolerance. It is a common condition that affects over 15% of general surgical patients undergoing major abdominal surgery. It is well recognized that this is a high-risk surgical population that is at increased risk of perioperative complications such as anastomotic dehiscence, poor wound healing, and postoperative ileus which can lead to an increased LOS after surgery. However, there is a relative dearth of robust evidence regarding preoperative fasting in patients with type 2 diabetes so there is no consensus among professional association guidelines internationally on recommendations for carbohydrate loading in this population undergoing elective surgery. Two major concerns have been raised; first the risk of aspiration in diabetic patients with a significant neuropathy and gastroparesis, and second potential for hyperglycemia and its deleterious effects.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- 40g carbohydrate load (Apple juice)
- 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.
40g carbohydrate load (Apple juice)Other
A 40g carbohydrate drink will be administered to subjects with non-insulin dependent type 2 diabetes 3 hours prior to their operation. This is standard practice in subjects without diabetes.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Modern fasting guidelines without the carbohydrate load preoperatively. |
| Intervention Arm | Experimental | 40g carbohydrate load preoperatively. Receives: Other: 40g carbohydrate load (Apple juice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative glucose
Mean difference in preoperative glucose between the two groups
Measured: 1 to 2 hours prior to operation time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start31 Aug 2017
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
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.
- More trials run by University of AlbertaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haili Wang, MD, Principal investigator, Alberta Health services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495114
- Sponsor's protocol ID
- RES0034025
- Status last verified
- Jul 2020
- First submitted
- 23 Jul 2020
- Last updated
- 31 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative Carbohydrate Loading Patients With Diabetes Undergoing Elective Colorectal Surgery
- ClinicalTrials.gov ID
- NCT04495114
- Acronym / sponsor ID
- RES0034025
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 31 Aug 2017 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 31 Jul 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.
Goal 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 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.
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 to aspiration due to delayed gastric emptying.
Detailed description
Fasting prior to the administration of a general anesthetic has been the standard of peri-operative care for many years. The refrain of "nothing to eat or drink after midnight" has become synonymous with surgery for both clinicians and the general public. The rationale behind this practice has been to reduce the risk of regurgitation of gastric contents. In addition, this instruction is straightforward for patients and ancillary staff, and allows for easy alteration of the order of cases on the operative list. Despite the widespread nature of this practice, a 2003 Cochrane review attempted to define the optimum duration of fasting, type of fasting, and volume of intake permitted and concluded that there was no evidence to suggest a shortened fluid fast resulted in an increased risk of aspiration, regurgitation, or morbidity in healthy patients.
Pre-operative fasting leads to insulin resistance and metabolic stresses. More recently it has been suggested that a preoperative carbohydrate loading may alleviate some deleterious effects of this fast. This strategy, combined with a number of others, have been recently introduced in many Enhanced Recovery After Surgery (ERAS) programs, that have led to improved postoperative pain, faster restoration of GI function, decreased LOS and decreased complication rate after colon surgery.
Type 2 diabetes is a disease of impaired glucose tolerance. It is a common condition that affects over 15% of general surgical patients undergoing major abdominal surgery. It is well recognized that this is a high-risk surgical population that is at increased risk of perioperative complications such as anastomotic dehiscence, poor wound healing, and postoperative ileus which can lead to an increased LOS after surgery. However, there is a relative dearth of robust evidence regarding preoperative fasting in patients with type 2 diabetes so there is no consensus among professional association guidelines internationally on recommendations for carbohydrate loading in this population undergoing elective surgery. Two major concerns have been raised; first the risk of aspiration in diabetic patients with a significant neuropathy and gastroparesis, and second potential for hyperglycemia and its deleterious effects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Modern fasting guidelines without the carbohydrate load preoperatively. |
| Intervention Arm | Experimental | Other: 40g carbohydrate load (Apple juice)40g carbohydrate load preoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetes, non-insulin dependent.
- Elective colorectal surgery patient at the University of Alberta Hospital, Grey Nuns Hospital, Misericordia Hospital, Foothills Hospital, or Royal Alexandra Hospital.
Key exclusion criteria (1 listed)
- Insulin dependent type 2 diabetes
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 |
|---|---|---|
| 40g carbohydrate load (Apple juice)A 40g carbohydrate drink will be administered to subjects with non-insulin dependent type 2 diabetes 3 hours prior to their operation. This is standard practice in subjects without diabetes. | Other | Intervention Arm |
Primary outcome
Preoperative glucose
Time frame: 1 to 2 hours prior to operation time.
Mean difference in preoperative glucose between the two groups
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 31 Jul 2020.
- Individual participant dataSharing planned: Yes
Related trials for Diabetes Mellitus, Type 2
Recruiting
Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
Heart Failure, Diabetes
Recruiting
Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin
Type 2 Diabetes
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
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.
Haili Wang, MD principal investigator
Alberta Health services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 40g carbohydrate load (Apple juice) in people with Diabetes Mellitus, Type 2, 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 2 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 31 Jul 2020. 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?
Preoperative glucose (time frame: 1 to 2 hours prior to operation time.). 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 31 Jul 2020.