CarbohydrateNCT06243367
Preoperative Oral Carbohydrate Loading Versus Fasting in Patients Undergoing Major Abdominal Surgery
A study testing Carbohydrate in people with Carbohydrate and Fasting, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the effect of preoperative carbohydrate load versus the fasting protocol in patients undergoing major abdominal operations. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Carbohydrate, Fasting, Major Abdominal Surgery
- What is being tested?
- Carbohydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Apr 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 21 and 70 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status l \& ll.
- Scheduled for elective major abdominal surgery
Who cannot join
- Disseminated malignant disease.
- Increased risk for gastric content aspiration.
- Body Mass Index (BMI) below 20 or above 30 kg/m2.
- Nutritional risk screening 2002 score above 3.
- Emergency surgery, diabetic patients, immunomodulatory therapy.
- Refusal of the patient.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Eman M Abo-Omar, Master, 00201090822808, emantaher6669@gmail.com
Sohair M Soliman, MD
About this study
Official title: Randomized Controlled Study of Preoperative Oral Carbohydrate Loading Versus Fasting in Patients Undergoing Major Abdominal Surgery
The aim of this study is to compare the effect of preoperative carbohydrate load versus the fasting protocol in patients undergoing major abdominal operations.
Read the detailed description
The surgical patients are influenced by many stressors during operation such as the prolonged fasting hours. Importantly, these stressors are iatrogenic and have been shown to disturb homeostasis with little benefit. Surgery itself, induces an endocrine and inflammatory stress response and contributes to postoperative insulin resistance (PIR) which increased also by Preoperative fasting.
Postoperative insulin resistance is a state of reduced insulin-mediated glucose uptake in skeletal muscles and adipose tissue, with an increased glucose release due to hepatic gluconeogenesis and hyperglycemia.
Strategies to reduce the postoperative stress response and postoperative insulin resistance include shortening the preoperative fasting time via preoperative carbohydrate oral drink administration (carbohydrate load). Preoperative fasting is the first step in postoperative insulin resistance development. The traditional fasting time of 6-8 h before elective surgery to prevent pulmonary aspiration usually extends up to 12 h in anesthetic practice. Overnight fasting is a physiological state of reduced insulin sensitivity due to the normal hormonal diurnal rhythm. If patients undergo surgery in the prolonged fasted state, insulin resistance may begin even before surgery.
A preoperative carbohydrate drink acts as a morning meal, may improve insulin sensitivity and propel the patient's metabolic state towards anabolism. The rationale of this study is to compare the differences between preoperative CHO loading and a conventional fasting protocol on the postoperative insulin resistance, Glasgow prognostic score (GPS), subjective patient well-being and surgical clinical outcome.
- Conditions
- Carbohydrate, Fasting, Major Abdominal Surgery
- Being tested
- Placebo drink, Carbohydrate
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo drinkOther
Patients were instructed to be fasting for 6 hours before surgery and received only placebo drink (200 ml clear water) two hours before surgery
CarbohydrateDietary supplement
Patients were given a meal of cup of yogurt (100 ml) with 2 spoonful of honey (42 gm) at midnight before surgery and 200 ml of a clear carbohydrate drink on the day of surgery, 2 h before anesthesia induction. This drink consisted of 200 ml water in which two spoonful of honey were dissolved.
| Study group | Role | What they receive |
|---|---|---|
| Fast (Control) group | Placebo comparator | Patients were instructed to be fasting for 6 hours before surgery and received only placebo drink (200 ml clear water) two hours before surgery Receives: Other: Placebo drink |
| Carbohydrate group | Experimental | Patients were given a meal of cup of yogurt (100 ml) with 2 spoonful of honey (42 gm) at midnight before surgery and 200 ml of a clear carbohydrate drink on the day of surgery, 2 h before anesthesia induction. This drink consisted of 200 ml water in which two spoonful of honey were dissolved. Receives: Dietary Supplement: Carbohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The metabolic response
The patient was also subjected to further assessment by bioelectrical impedence analysis for measuring of the basal body muscle mass preoperatively and 5 days postoperatively.
Measured: 5 days postoperatively
Secondary outcomes (4)
The postoperative inflammatory response
Postoperative inflammatory response was assessed at 6 o'clock A.M on the day of surgery (T1, basal value), 6 h after surgery (T2), at 6 o'clock A.M on postoperative day 1 (T3) .
Measured: First day postoperative
Complications
Complications such as nausea and vomiting were assessed preoperatively and at intervals 4, 8, 12, and 24 hours postoperatively
Measured: 24 hours postoperatively
Time of independent ambulation
Time of independent ambulation will be recorded.
Measured: 27 days postoperatively
Postoperative discharge day
Postoperative discharge day will be recorded.
Measured: 27 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start1 Jan 2022
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarbohydrateStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mohammed Taher Salem Abo-Omar, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243367
- Sponsor's protocol ID
- 35129/12/21
- Status last verified
- Feb 2024
- First submitted
- 14 Jan 2024
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study of Preoperative Oral Carbohydrate Loading Versus Fasting in Patients Undergoing Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06243367
- Acronym / sponsor ID
- 35129/12/21
- Conditions
- Carbohydrate, Fasting, Major Abdominal Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 6 Feb 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.
The aim of this study is to compare the effect of preoperative carbohydrate load versus the fasting protocol in patients undergoing major abdominal operations.
Detailed description
The surgical patients are influenced by many stressors during operation such as the prolonged fasting hours. Importantly, these stressors are iatrogenic and have been shown to disturb homeostasis with little benefit. Surgery itself, induces an endocrine and inflammatory stress response and contributes to postoperative insulin resistance (PIR) which increased also by Preoperative fasting.
Postoperative insulin resistance is a state of reduced insulin-mediated glucose uptake in skeletal muscles and adipose tissue, with an increased glucose release due to hepatic gluconeogenesis and hyperglycemia.
Strategies to reduce the postoperative stress response and postoperative insulin resistance include shortening the preoperative fasting time via preoperative carbohydrate oral drink administration (carbohydrate load). Preoperative fasting is the first step in postoperative insulin resistance development. The traditional fasting time of 6-8 h before elective surgery to prevent pulmonary aspiration usually extends up to 12 h in anesthetic practice. Overnight fasting is a physiological state of reduced insulin sensitivity due to the normal hormonal diurnal rhythm. If patients undergo surgery in the prolonged fasted state, insulin resistance may begin even before surgery.
A preoperative carbohydrate drink acts as a morning meal, may improve insulin sensitivity and propel the patient's metabolic state towards anabolism. The rationale of this study is to compare the differences between preoperative CHO loading and a conventional fasting protocol on the postoperative insulin resistance, Glasgow prognostic score (GPS), subjective patient well-being and surgical clinical outcome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fast (Control) group | Placebo comparator | Other: Placebo drinkPatients were instructed to be fasting for 6 hours before surgery and received only placebo drink (200 ml clear water) two hours before surgery |
| Carbohydrate group | Experimental | Dietary Supplement: CarbohydratePatients were given a meal of cup of yogurt (100 ml) with 2 spoonful of honey (42 gm) at midnight before surgery and 200 ml of a clear carbohydrate drink on the day of surgery, 2 h before anesthesia induction. This drink consisted of 200 ml water in which two spoonful of honey were dissolved. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 21 and 70 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status l \& ll.
- Scheduled for elective major abdominal surgery
Key exclusion criteria (6 listed)
- Disseminated malignant disease.
- Increased risk for gastric content aspiration.
- Body Mass Index (BMI) below 20 or above 30 kg/m2.
- Nutritional risk screening 2002 score above 3.
- Emergency surgery, diabetic patients, immunomodulatory therapy.
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 |
|---|---|---|
| Placebo drinkPatients were instructed to be fasting for 6 hours before surgery and received only placebo drink (200 ml clear water) two hours before surgery | Other | Fast (Control) group |
| CarbohydratePatients were given a meal of cup of yogurt (100 ml) with 2 spoonful of honey (42 gm) at midnight before surgery and 200 ml of a clear carbohydrate drink on the day of surgery, 2 h before anesthesia induction. This drink consisted of 200 ml water in which two spoonful of honey were dissolved. | Dietary supplement | Carbohydrate group |
Primary outcome
The metabolic response
Time frame: 5 days postoperatively
The patient was also subjected to further assessment by bioelectrical impedence analysis for measuring of the basal body muscle mass preoperatively and 5 days postoperatively.
4 secondary outcomes
The postoperative inflammatory response
Time frame: First day postoperative
Complications
Time frame: 24 hours postoperatively
Time of independent ambulation
Time frame: 27 days postoperatively
Postoperative discharge day
Time frame: 27 days postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Carbohydrate in people with Carbohydrate and Fasting, run by Tanta 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 4 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: status not confirmed, as of the sponsor's last update on 6 Feb 2024. 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. Some participants in this study may receive a placebo. 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?
Contact Eman M AboOmar, Master (00201090822808, emantaher6669@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The metabolic response (time frame: 5 days postoperatively). 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 6 Feb 2024.