Bariatric SurgeryNCT05692414
Preoperative Carbohydrate Loading in Bariatric Surgery - Clinical Trial
A study testing Preoperative carbohydrate drink in people with Bariatric Surgery and Carbohydrate Loading, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
Insulin resistance is a key feature of postoperative metabolism, leading to decreased glucose absorption in adipose tissue and skeletal muscle, with an increased glucose release due to hepatic gluconeogenesis and hyperglycemia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bariatric Surgery, Carbohydrate Loading
- What is being tested?
- Preoperative carbohydrate drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2023to May 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who will undergo surgery at the Elective Surgery Clinic of the University Clinical Centre in Gdansk, Poland.
Who cannot join
- Patients who will be unable or will refuse to express informed concern
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
University Clinical Centre in Gdansk
Gdansk, Pomeranian, 80-952
Andrii Bilyk, 576188525 ext. +48, andrii.bilyk@gumed.edu.pl
About this study
Insulin resistance is a key feature of postoperative metabolism, leading to decreased glucose absorption in adipose tissue and skeletal muscle, with an increased glucose release due to hepatic gluconeogenesis and hyperglycemia. Development of insulin resistance is associated with increased length of hospital stay (LOS), morbidity, and mortality. One of the strategies employed to reduce the postoperative stress response and perioperative insulin resistance includes the reduction of the preoperative fasting time via preoperative carbohydrate oral (CHO) drink. Preoperative carbohydrate intake is an integral part of the Enhanced Recovery After Surgery (ERAS) protocol and previous studies have shown that preoperative carbohydrate loading can increase patient comfort. Although ERAS protocols are increasingly used and implemented in bariatric surgery centres specific components of these protocols, such as preoperative oral carbohydrate nutrition, have not yet been rigorously analyzed.
The aim of this prospective study is to compare the differences in patient outcomes between preoperative CHO loading and a conventional fasting protocol. The secondary aim is to perform a subgroup analysis of Roux-en-Y bypass and sleeve gastrectomy.
- Conditions
- Bariatric Surgery, Carbohydrate Loading
- Being tested
- Preoperative carbohydrate drink
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative carbohydrate drinkDietary supplement
Allocation will be performed using an alternating weeks scheme. Patients undergoing surgery in the first week will be included in the control group and follow a conventional fasting protocol. However, patients undergoing surgery the following week will be included in the intervention group and take 800 ml of CHO drink on the day before surgery and 400 ml on the surgery day no later than 6 hours before the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative carbohydrate loaded patients | Experimental | Not described Receives: Dietary Supplement: Preoperative carbohydrate drink |
| Conventional fasting protocol | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose level
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study startJan 2023 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrii Bilyk, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692414
- Sponsor's protocol ID
- NKBBN/200/2020
- Status last verified
- Jan 2023
- First submitted
- 11 Jan 2023
- Last updated
- 20 Jan 2023
- 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 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Carbohydrate Loading in Bariatric Surgery - Clinical Trial
- ClinicalTrials.gov ID
- NCT05692414
- Acronym / sponsor ID
- NKBBN/200/2020
- Conditions
- Bariatric Surgery, Carbohydrate Loading
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 20 Jan 2023 (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.
Insulin resistance is a key feature of postoperative metabolism, leading to decreased glucose absorption in adipose tissue and skeletal muscle, with an increased glucose release due to hepatic gluconeogenesis and hyperglycemia. Development of insulin resistance is associated with increased length of hospital stay (LOS), morbidity, and mortality. One of the strategies employed to reduce the postoperative stress response and perioperative insulin resistance includes the reduction of the preoperative fasting time via preoperative carbohydrate oral (CHO) drink. Preoperative carbohydrate intake is an integral part of the Enhanced Recovery After Surgery (ERAS) protocol and previous studies have shown that preoperative carbohydrate loading can increase patient comfort. Although ERAS protocols are increasingly used and implemented in bariatric surgery centres specific components of these protocols, such as preoperative oral carbohydrate nutrition, have not yet been rigorously analyzed.
The aim of this prospective study is to compare the differences in patient outcomes between preoperative CHO loading and a conventional fasting protocol. The secondary aim is to perform a subgroup analysis of Roux-en-Y bypass and sleeve gastrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative carbohydrate loaded patients | Experimental | Dietary Supplement: Preoperative carbohydrate drink |
| Conventional fasting protocol | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who will undergo surgery at the Elective Surgery Clinic of the University Clinical Centre in Gdansk, Poland.
Key exclusion criteria (1 listed)
- Patients who will be unable or will refuse to express informed concern
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 carbohydrate drinkAllocation will be performed using an alternating weeks scheme. Patients undergoing surgery in the first week will be included in the control group and follow a conventional fasting protocol. However, patients undergoing surgery the following week will be included in the intervention group and take 800 ml of CHO drink on the day before surgery and 400 ml on the surgery day no later than 6 hours before the procedure. | Dietary supplement | Preoperative carbohydrate loaded patients |
Primary outcome
Glucose level
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative carbohydrate drink in people with Bariatric Surgery and Carbohydrate Loading, run by Medical University of Gdansk at 1 site in Poland.
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: status not confirmed, as of the sponsor's last update on 20 Jan 2023. 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 Poland. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose level (time frame: 10 days). 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 20 Jan 2023.