Obesity, MorbidPhase 4NCT04486079
Preoperative Carbohydrate Loading in Bariatric Surgery
A Phase 4 study testing Nutricia PreOp in people with Obesity, Morbid, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
The aim of this study is to perform a randomized non-blinded clinical trial to assess influence of preoperative carbohydrates loading in patients undergoing bariatric surgery measured by changes in the course of the postoperative period, changes in body composition and changes in insulin resistance Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- Nutricia PreOp
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 sitePoland
- Study dates
- 20 Jul 2020to 31 Oct 2021
- Phase
- Phase 4
- 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
- Obtaining written and informed patient consent.
- No medical contraindications to perform a bariatric operation
- No contraindications for the use of a rich carbohydrate drink
Who cannot join
- No consent to participate in the study
- Age under 18 years
- The intolerance of the carbohydrate drink used in the test
- The contraindications to perform bioimpedance measurements of body composition
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of General, Endocrine and Transplant Surgery Medical University of Gdańsk
Gdansk, Pomeranian Voivodeship, 80-214
Maciej Wilczyński, doctor, 603383368 ext. +48, mwilczynski@gumed.edu.pl
About this study
Official title: Preoperative Carbohydrate Loading in Bariatric Surgery - Randomized Clinical Trail
The aim of this study is to perform a randomized non-blinded clinical trial to assess influence of preoperative carbohydrates loading in patients undergoing bariatric surgery measured by changes in the course of the postoperative period, changes in body composition and changes in insulin resistance
- Conditions
- Obesity, Morbid
- Being tested
- Nutricia PreOp
- Keywords
- bariatric surgery, carbohydrate loading, insulin resistance
- Medical subject headings
- Obesity, Morbid, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutricia PreOpDietary supplement
A clear, non-carbonated lemon-flavored, iso-osmolar carbohydrate drink for preoperative surgical patients. Used in studies supporting the Enhanced Recovery After Surgery (ERAS) Society Consensus Guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Carbohyrate loading | Experimental | Group A will receive 400ml of the carbohydrate rich drink, Nutricia preOp 2 hours before operation. This is the intervention group. Receives: Dietary Supplement: Nutricia PreOp |
| Fasting | No intervention | Group B will be prepared before the operation with a 24-hour fasting. This is the current clinical standard. |
What is being measured
The primary outcome is the main question the study is designed to answer.
QoR40 score
Quality of recovery after surgery will be assessed by the QoR40 survey Full scale title: Quality of Recovery 40-item questionnaires range from 40 (extremely poor. quality of recovery) to 200 (excellent quality of recovery)
Measured: 1st postoperatie day
Secondary outcomes (3)
HOMA-IR
changes in insulin resistance will be assessed with HOMA index (Homeostatic Model Assessment for Insulin Resistance)
Measured: first assay one month before the operation, the second assay on the first postoperative day
Body composition
changes in body composition will be assessed by electric bioimpedance method
Measured: first assay one month before the operation, the second assay on the first postoperative day
Length of hospital stay
length of stay record in hours
Measured: From the time of hospital admission following surgery, until the time of hospital discharge; assessed from day of hospital admision up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start20 Jul 2020 (estimated)
- Primary completion20 Jul 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obesity, MorbidStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maciej Wilczyński, Principal investigator, General Surgery Resident, PhD Fellow, Teaching Assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486079
- Sponsor's protocol ID
- PreOpxBariatric
- Status last verified
- Jul 2020
- First submitted
- 12 Jul 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Medical University of Gdańsk will be the owner of data
Publications
Knight P, Chou J, Dusseljee M, Verseman S, Elian A. Effective reduction in stress induced postoperative hyperglycemia in bariatric surgery by better carb loading. Am J Surg. 2020 Mar;219(3):396-398. doi: 10.1016/j.amjsurg.2019.10.042. Epub 2019 Nov 9.
PubMed 31757437Grant MC, Gibbons MM, Ko CY, Wick EC, Cannesson M, Scott MJ, McEvoy MD, King AB, Wu CL. Evidence Review Conducted for the Agency for Healthcare Research and Quality Safety Program for Improving Surgical Care and Recovery: Focus on Anesthesiology for Bariatric Surgery. Anesth Analg. 2019 Jul;129(1):51-60. doi: 10.1213/ANE.0000000000003696.
PubMed 30113392Amer MA, Smith MD, Herbison GP, Plank LD, McCall JL. Network meta-analysis of the effect of preoperative carbohydrate loading on recovery after elective surgery. Br J Surg. 2017 Feb;104(3):187-197. doi: 10.1002/bjs.10408. Epub 2016 Dec 21.
PubMed 28000931Thorell A, MacCormick AD, Awad S, Reynolds N, Roulin D, Demartines N, Vignaud M, Alvarez A, Singh PM, Lobo DN. Guidelines for Perioperative Care in Bariatric Surgery: Enhanced Recovery After Surgery (ERAS) Society Recommendations. World J Surg. 2016 Sep;40(9):2065-83. doi: 10.1007/s00268-016-3492-3.
PubMed 26943657
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Carbohydrate Loading in Bariatric Surgery - Randomized Clinical Trail
- ClinicalTrials.gov ID
- NCT04486079
- Acronym / sponsor ID
- PreOpxBariatric
- Conditions
- Obesity, Morbid
- Keywords
- bariatric surgery, carbohydrate loading, insulin resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 20 Jul 2020 (estimated)
- Primary completion
- 20 Jul 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 24 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.
The aim of this study is to perform a randomized non-blinded clinical trial to assess influence of preoperative carbohydrates loading in patients undergoing bariatric surgery measured by changes in the course of the postoperative period, changes in body composition and changes in insulin resistance
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbohyrate loading | Experimental | Dietary Supplement: Nutricia PreOpGroup A will receive 400ml of the carbohydrate rich drink, Nutricia preOp 2 hours before operation. This is the intervention group. |
| Fasting | No intervention | –Group B will be prepared before the operation with a 24-hour fasting. This is the current clinical standard. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Obtaining written and informed patient consent.
- No medical contraindications to perform a bariatric operation
- No contraindications for the use of a rich carbohydrate drink
Key exclusion criteria (4 listed)
- No consent to participate in the study
- Age under 18 years
- The intolerance of the carbohydrate drink used in the test
- The contraindications to perform bioimpedance measurements of body composition
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 |
|---|---|---|
| Nutricia PreOpA clear, non-carbonated lemon-flavored, iso-osmolar carbohydrate drink for preoperative surgical patients. Used in studies supporting the Enhanced Recovery After Surgery (ERAS) Society Consensus Guidelines. | Dietary supplement | Carbohyrate loading |
Primary outcome
QoR40 score
Time frame: 1st postoperatie day
Quality of recovery after surgery will be assessed by the QoR40 survey Full scale title: Quality of Recovery 40-item questionnaires range from 40 (extremely poor. quality of recovery) to 200 (excellent quality of recovery)
3 secondary outcomes
HOMA-IR
Time frame: first assay one month before the operation, the second assay on the first postoperative day
Body composition
Time frame: first assay one month before the operation, the second assay on the first postoperative day
Length of hospital stay
Time frame: From the time of hospital admission following surgery, until the time of hospital discharge; assessed from day of hospital admision up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Results publication: PubMed 31757437Knight P, Chou J, Dusseljee M, Verseman S, Elian A. Effective reduction in stress induced postoperative hyperglycemia in bariatric surgery by better carb loading. Am J Surg. 2020 Mar;219(3):396-398. doi: 10.1016/j.amjsurg.2019.10.042. Epub 2019 Nov 9.
- Results publication: PubMed 30113392Grant MC, Gibbons MM, Ko CY, Wick EC, Cannesson M, Scott MJ, McEvoy MD, King AB, Wu CL. Evidence Review Conducted for the Agency for Healthcare Research and Quality Safety Program for Improving Surgical Care and Recovery: Focus on Anesthesiology for Bariatric Surgery. Anesth Analg. 2019 Jul;129(1):51-60. doi: 10.1213/ANE.0000000000003696.
- Results publication: PubMed 28000931Amer MA, Smith MD, Herbison GP, Plank LD, McCall JL. Network meta-analysis of the effect of preoperative carbohydrate loading on recovery after elective surgery. Br J Surg. 2017 Feb;104(3):187-197. doi: 10.1002/bjs.10408. Epub 2016 Dec 21.
- Results publication: PubMed 26943657Thorell A, MacCormick AD, Awad S, Reynolds N, Roulin D, Demartines N, Vignaud M, Alvarez A, Singh PM, Lobo DN. Guidelines for Perioperative Care in Bariatric Surgery: Enhanced Recovery After Surgery (ERAS) Society Recommendations. World J Surg. 2016 Sep;40(9):2065-83. doi: 10.1007/s00268-016-3492-3.
- Individual participant dataSharing planned: No. Medical University of Gdańsk will be the owner of data
Related trials for Obesity, Morbid
Active, not recruiting
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Bariatric Surgery Candidate, Obesity
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
RecruitingPhase 3
Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
Obesity, Childhood, Insulin Resistance
RecruitingPhase 4
Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
Liver Cirrhoses, Portal Hypertension Related to Cirrhosis
RecruitingPhase 3
A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults
Monogenic Obesity
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.
Maciej Wilczyński principal investigator
General Surgery Resident, PhD Fellow, Teaching Assistant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nutricia PreOp in people with Obesity, Morbid, 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 3 inclusion and 4 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 24 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Maciej Wilczyński (603383368, mwilczynski@gumed.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QoR40 score (time frame: 1st postoperatie day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04486079, which also lists 4 linked publications.
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 Jul 2020.