Postoperative Oral CarbohydratesEarly Phase 1NCT05867264
Effect of Early Postoperative Oral Carbohydrate on Postoperative Recovery of the Unilateral Knee Arthroplasty
A Early Phase 1 study testing Early drinking water, Early consumption of carbohydrates and Late feeding group in people with Postoperative Oral Carbohydrates and Postoperative Recovery, run by Hongwei Shi.
Trial summary
To evaluate the effect of early postoperative oral carbohydrate on postoperative recovery of the unilateral knee arthroplasty Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Oral Carbohydrates, Postoperative Recovery, Unilateral Knee Arthroplasty
- What is being tested?
- Early drinking water, Early consumption of carbohydrates and Late feeding group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 672 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2023to 30 Dec 2024
- Phase
- Early Phase 1
- 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 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-79 years.
- Patients undergoing unilateral total knee arthroplasty or unicondylar joint replacement.
- Normal diet.
- ASA grade I~Ⅲ;
- BMI 18-30kg /m2.
- No intraspinal anesthesia contraindications.
Who cannot join
- Preoperative existence of gastric emptying disorders, such as gastrointestinal obstruction, gastroesophageal reflux, or previous gastrointestinal surgery.
- Patients with diabetes mellitus, severe renal dysfunction, or other severe metabolic diseases.
- History of motion sickness.
- Mental disorder, alcoholism, or a history of substance abuse.
- Patients with abnormal swallowing function.
- The operation time is greater than 3 hours.
- Maltodextrin fructose allergy or intolerance.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Early Postoperative Oral Carbohydrate on Postoperative Recovery of the Unilateral Knee Arthroplasty: a Randomized, Single-blind, Parallel-controlled, Multicenter Study
To evaluate the effect of early postoperative oral carbohydrate on postoperative recovery of the unilateral knee arthroplasty
Read the detailed description
Currently, most clinical studies on the impact of oral carbohydrates on postoperative recovery are focused on the preoperative stage, with only a few small sample studies indicating that postoperative oral carbohydrates can improve patient comfort. Orthopedic surgery, especially joint surgery, requires patients to start functional exercise as soon as possible after surgery. Joint replacement surgery requires reducing the consumption of muscle tissue caused by protein breakdown. Perioperative nutritional support for patients is of great significance for postoperative muscle function recovery and good functional exercise. However, further systematic research on the impact of early postoperative oral carbohydrates on postoperative recovery is still lacking.
This study selected patients who underwent unilateral total knee arthroplasty or single condylar arthroplasty. All surgical patients undergo homogenized preoperative preparation and intraoperative anesthesia management. Eligible patients were screened before surgery, and an informed consent form was signed. Patients enrolled in the experiment were randomly assigned into one of the three groups. They are the early feeding group (EOF1, EOF2group) and the late feeding group （control group）. Evaluate the effectiveness and safety of early postoperative feeding （EOF） in orthopedic surgery patients by measuring indicators such as insulin resistance index, QoR-15, and prealbumin and retinol binding protein.
- Being tested
- Early drinking water, Early consumption of carbohydrates, Late feeding group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early drinking waterOther
After passing the evaluation by the anesthesiologist team in PACU, the EOF1 group drank 200ml of water.
The evaluation criteria for the anesthesiologist team are:
- Steward's awakening score is ≥ 6 points.
- Level of sobriety ≥ 3.
- There is no need to wait for intestinal peristalsis, based on the patient's wishes, and the feeding should be completed within 2 hours after the surgery.
Early consumption of carbohydratesCombination product
After passing the evaluation by the anesthesiologist team in PACU, the EOF2 group had a drinking capacity of 200ml of 12.5% carbohydrates (100ml containing 12.5g of maltodextrin, fructose, and glucose).
The evaluation criteria for the anesthesiologist team are:
- Steward's awakening score is 6 points.
- Level of sobriety ≥ 3.
- There is no need to wait for intestinal peristalsis, based on the patient's wishes, and the feeding should be completed within 2 hours after the surgery.
Late feeding groupOther
After observing the vital signs for 30 minutes after surgery, patients in Group C were sent back to the ward to continue fasting and drinking for at least 6 hours. After the anus exhausts, they began to gradually drink and eat
| Study group | Role | What they receive |
|---|---|---|
| EOF 1 group：Early drinking water group | Placebo comparator | After passing the evaluation by the anesthesiologist team in PACU, the EOF1 group drank 200ml of water. Receives: Other: Early drinking water |
| EOF 2 group: Early oral carbohydrate group | Experimental | After passing the evaluation by the anesthesiologist team in PACU, the EOF2 group had a drinking capacity of 200ml of 12.5% carbohydrates (100ml containing 12.5g of maltodextrin, fructose, and glucose). Receives: Combination Product: Early consumption of carbohydrates |
| Control group: Late feeding group | Placebo comparator | After observing the vital signs for 30 minutes after surgery, patients in Group C were sent back to the ward to continue fasting and drinking for at least 6 hours. After the anus exhausts, they began to gradually drink and eat Receives: Other: Late feeding group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin resistance index at fasting
In the venous blood in an early morning fasting state, the change in the insulin resistance index can reflect whether the carbohydrate administration is favorable in the early postoperative period.
Measured: 1 day after surgery
Secondary outcomes (14)
Insulin resistance index at fasting
In the venous blood in an early morning fasting state, the change in the insulin resistance index can reflect whether the carbohydrate administration is favorable in the early postoperative period.
Measured: on the day of the surgery
Insulin resistance index at fasting
In the venous blood in an early morning fasting state, the change in the insulin resistance index can reflect whether the carbohydrate administration is favorable in the early postoperative period.
Measured: 3 days after surgery
Pre albumin levels and retinol binding protein levels
The change in prealbumin levels and retinol-binding protein levels in venous blood in a fasting state in the early morning can reflect whether carbohydrate administration is favorable in the early postoperative period. Three of the eight test centers examined the pre-albumin levels and retinol-binding protein levels.
Measured: on the day of surgery, 1 day and 3 days after surgery.
The 15-item recovery quality rating scale （QoR-15）
QoR-15 was used to assess five aspects of postoperative recovery quality (physical comfort, physical independence, psychological support, emotion and pain), with higher scores indicating the higher postoperative recovery quality. The lowest score is 0 points, and the highest score is 150 points.
Measured: Up to 48 hours postoperative
The NRS score for the thirst thirst and hunger.
The Numerical Rating Scale (NRS) is used to assess the degree of thirst and hunger in patients, with a score of 0 to 10. A score of 0 represents no thirst and no hunger, while a score of 10 represents unbearable thirst and hunger. The thirst and hunger score indicates that early postoperative carbohydrate administration is beneficial.
Measured: 2 hours, 6 hours and 8 hours after surgery
The degree of abdominal distension
Using grading method, complaining of abdominal distention, tolerable, feeling gas rolling in the abdomen, no obvious abdominal signs, mild abdominal distension, abdominal distention, moderate abdominal distension, vomiting, dyspnea, and significant abdominal bulge.
Measured: 24 hours after surgery
Incidence of reflux aspiration and hypoxemia
Reflux aspiration is defined as severe cough followed by hypoxemia and lung rale after vomiting. Hypoxemia is defined as SpO2<91% under air inhalation.
Measured: 24 hours after surgery
Anal exhaust time
The advanced time of the first postoperative anal exhaust indicates a favorable early postoperative carbohydrate administration.
Measured: Up to 48 hours postoperative
Incidence of postoperative nausea and vomiting
The lower the incidence and severity of postoperative nausea and vomiting, indicating that early administration of carbohydrates after surgery is beneficial.
Measured: Up to 48 hours postoperative
Hospitalization time
The shortened length of hospital stay indicated that early postoperative carbohydrate administration was advantageous.
Measured: Up to 7days postoperative
The extent of the postoperative pain
The total amount of sufentanil consumed by the patient 48 hours after operation, the number of effective presses of the analgesia pump, the number of times of rescue analgesia and the amount of rescue drugs were converted into the total amount of morphine.
Measured: Up to 48 hours postoperative
Patient satisfaction score
Rated on a 0-10 scale, with a higher score representing greater satisfaction.
Measured: Up to 48 hours postoperative
The incidence and severity of various adverse events （AE） from the start of oral carbohydrates until the end of the trial
The lower the incidence and severity of various adverse events (AE) from the start of postoperative oral carbohydrates until the end of the trial, it indicates that the early postoperative carbohydrate administration is beneficial.
Measured: Up to 48 hours postoperative
Number of antiemetic uses
The less use of antiemetic drugs within 24h after the first start of postoperative administration indicates that early postoperative carbohydrate administration is advantageous.
Measured: Up to 24 hours after the first start of drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start25 May 2023 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Postoperative Oral CarbohydratesStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 672 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hongwei Shi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hongwei Shi, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867264
- Sponsor's protocol ID
- Nanjing First Hospital
- Status last verified
- May 2023
- First submitted
- 8 Apr 2023
- Last updated
- 19 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miller TE, Roche AM, Mythen M. Fluid management and goal-directed therapy as an adjunct to Enhanced Recovery After Surgery (ERAS). Can J Anaesth. 2015 Feb;62(2):158-68. doi: 10.1007/s12630-014-0266-y. Epub 2014 Nov 13.
PubMed 25391735Rizvanovic N, Nesek Adam V, Causevic S, Dervisevic S, Delibegovic S. A randomised controlled study of preoperative oral carbohydrate loading versus fasting in patients undergoing colorectal surgery. Int J Colorectal Dis. 2019 Sep;34(9):1551-1561. doi: 10.1007/s00384-019-03349-4. Epub 2019 Jul 15.
PubMed 31309323Nygren J, Thorell A, Ljungqvist O. Preoperative oral carbohydrate therapy. Curr Opin Anaesthesiol. 2015 Jun;28(3):364-9. doi: 10.1097/ACO.0000000000000192.
PubMed 25827282Surgery Branch of Chinese Medical Association, Anesthesiology Branch of Chinese Medical Society. Chinese Expert Consensus and Path Management Guidelines for Accelerating Rehabilitation Surgery (2018) [J]. Chinese Journal of Anesthesiology, 2018,38 (001): 8-13.
Yang R, Tao W, Chen YY, Zhang BH, Tang JM, Zhong S, Chen XX. Enhanced recovery after surgery programs versus traditional perioperative care in laparoscopic hepatectomy: A meta-analysis. Int J Surg. 2016 Dec;36(Pt A):274-282. doi: 10.1016/j.ijsu.2016.11.017. Epub 2016 Nov 10.
PubMed 27840308Bethune Orthopaedic Accelerated Rehabilitation Alliance, Bethune Charity Foundation Orthopaedic Professional Committee of trauma, Joint Surgery Professional Committee of Bethune Charity Foundation, etc. Guidelines for the management of perioperative fasting fasting in orthopaedic surgery [J]. Chinese Journal of Trauma and Orthopedics, 2019,21 (10): 829-834.
Smith MD, McCall J, Plank L, Herbison GP, Soop M, Nygren J. Preoperative carbohydrate treatment for enhancing recovery after elective surgery. Cochrane Database Syst Rev. 2014 Aug 14;2014(8):CD009161. doi: 10.1002/14651858.CD009161.pub2.
PubMed 25121931Noba L, Wakefield A. Are carbohydrate drinks more effective than preoperative fasting: A systematic review of randomised controlled trials. J Clin Nurs. 2019 Sep;28(17-18):3096-3116. doi: 10.1111/jocn.14919. Epub 2019 Jun 10.
PubMed 31112338[9] Wang Cuilan, Huang Yuting, Zeng Qing, et al. Study on postoperative fasting water prohibition time under ERAS concept [J]. Clinical Medical Engineering, 2022,29 (4): 2.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Postoperative Oral Carbohydrate on Postoperative Recovery of the Unilateral Knee Arthroplasty: a Randomized, Single-blind, Parallel-controlled, Multicenter Study
- ClinicalTrials.gov ID
- NCT05867264
- Acronym / sponsor ID
- Nanjing First Hospital
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 672 participants (estimated)
- Lead sponsor
- Hongwei ShiUniversity, hospital or other
- Study start
- 25 May 2023 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 19 May 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.
To evaluate the effect of early postoperative oral carbohydrate on postoperative recovery of the unilateral knee arthroplasty
Detailed description
Currently, most clinical studies on the impact of oral carbohydrates on postoperative recovery are focused on the preoperative stage, with only a few small sample studies indicating that postoperative oral carbohydrates can improve patient comfort. Orthopedic surgery, especially joint surgery, requires patients to start functional exercise as soon as possible after surgery. Joint replacement surgery requires reducing the consumption of muscle tissue caused by protein breakdown. Perioperative nutritional support for patients is of great significance for postoperative muscle function recovery and good functional exercise. However, further systematic research on the impact of early postoperative oral carbohydrates on postoperative recovery is still lacking.
This study selected patients who underwent unilateral total knee arthroplasty or single condylar arthroplasty. All surgical patients undergo homogenized preoperative preparation and intraoperative anesthesia management. Eligible patients were screened before surgery, and an informed consent form was signed. Patients enrolled in the experiment were randomly assigned into one of the three groups. They are the early feeding group (EOF1, EOF2group) and the late feeding group （control group）. Evaluate the effectiveness and safety of early postoperative feeding （EOF） in orthopedic surgery patients by measuring indicators such as insulin resistance index, QoR-15, and prealbumin and retinol binding protein.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EOF 1 group：Early drinking water group | Placebo comparator | Other: Early drinking waterAfter passing the evaluation by the anesthesiologist team in PACU, the EOF1 group drank 200ml of water. |
| EOF 2 group: Early oral carbohydrate group | Experimental | Combination Product: Early consumption of carbohydratesAfter passing the evaluation by the anesthesiologist team in PACU, the EOF2 group had a drinking capacity of 200ml of 12.5% carbohydrates (100ml containing 12.5g of maltodextrin, fructose, and glucose). |
| Control group: Late feeding group | Placebo comparator | Other: Late feeding groupAfter observing the vital signs for 30 minutes after surgery, patients in Group C were sent back to the ward to continue fasting and drinking for at least 6 hours. After the anus exhausts, they began to gradually drink and eat |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-79 years.
- Patients undergoing unilateral total knee arthroplasty or unicondylar joint replacement.
- Normal diet.
- ASA grade I~Ⅲ;
- BMI 18-30kg /m2.
Key exclusion criteria (7 listed)
- Preoperative existence of gastric emptying disorders, such as gastrointestinal obstruction, gastroesophageal reflux, or previous gastrointestinal surgery.
- Patients with diabetes mellitus, severe renal dysfunction, or other severe metabolic diseases.
- History of motion sickness.
- Mental disorder, alcoholism, or a history of substance abuse.
- Patients with abnormal swallowing function.
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 |
|---|---|---|
| Early drinking waterAfter passing the evaluation by the anesthesiologist team in PACU, the EOF1 group drank 200ml of water. The evaluation criteria for the anesthesiologist team are: 1. Steward's awakening score is ≥ 6 points. 2. Level of sobriety ≥ 3. 3. There is no need to wait for intestinal peristalsis, based on the patient's wishes, and the feeding should be completed within 2 hours after the surgery. | Other | EOF 1 group：Early drinking water group |
| Early consumption of carbohydratesAfter passing the evaluation by the anesthesiologist team in PACU, the EOF2 group had a drinking capacity of 200ml of 12.5% carbohydrates (100ml containing 12.5g of maltodextrin, fructose, and glucose). The evaluation criteria for the anesthesiologist team are: 1. Steward's awakening score is 6 points. 2. Level of sobriety ≥ 3. 3. There is no need to wait for intestinal peristalsis, based on the patient's wishes, and the feeding should be completed within 2 hours after the surgery. | Combination product | EOF 2 group: Early oral carbohydrate group |
| Late feeding groupAfter observing the vital signs for 30 minutes after surgery, patients in Group C were sent back to the ward to continue fasting and drinking for at least 6 hours. After the anus exhausts, they began to gradually drink and eat | Other | Control group: Late feeding group |
Primary outcome
Insulin resistance index at fasting
Time frame: 1 day after surgery
In the venous blood in an early morning fasting state, the change in the insulin resistance index can reflect whether the carbohydrate administration is favorable in the early postoperative period.
14 secondary outcomes
Insulin resistance index at fasting
Time frame: on the day of the surgery
Insulin resistance index at fasting
Time frame: 3 days after surgery
Pre albumin levels and retinol binding protein levels
Time frame: on the day of surgery, 1 day and 3 days after surgery.
The 15-item recovery quality rating scale （QoR-15）
Time frame: Up to 48 hours postoperative
The NRS score for the thirst thirst and hunger.
Time frame: 2 hours, 6 hours and 8 hours after surgery
The degree of abdominal distension
Time frame: 24 hours after surgery
Incidence of reflux aspiration and hypoxemia
Time frame: 24 hours after surgery
Anal exhaust time
Time frame: Up to 48 hours postoperative
Incidence of postoperative nausea and vomiting
Time frame: Up to 48 hours postoperative
Hospitalization time
Time frame: Up to 7days postoperative
The extent of the postoperative pain
Time frame: Up to 48 hours postoperative
Patient satisfaction score
Time frame: Up to 48 hours postoperative
The incidence and severity of various adverse events （AE） from the start of oral carbohydrates until the end of the trial
Time frame: Up to 48 hours postoperative
Number of antiemetic uses
Time frame: Up to 24 hours after the first start of drug administration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Background: PubMed 25391735Miller TE, Roche AM, Mythen M. Fluid management and goal-directed therapy as an adjunct to Enhanced Recovery After Surgery (ERAS). Can J Anaesth. 2015 Feb;62(2):158-68. doi: 10.1007/s12630-014-0266-y. Epub 2014 Nov 13.
- Background: PubMed 31309323Rizvanovic N, Nesek Adam V, Causevic S, Dervisevic S, Delibegovic S. A randomised controlled study of preoperative oral carbohydrate loading versus fasting in patients undergoing colorectal surgery. Int J Colorectal Dis. 2019 Sep;34(9):1551-1561. doi: 10.1007/s00384-019-03349-4. Epub 2019 Jul 15.
- Background: PubMed 25827282Nygren J, Thorell A, Ljungqvist O. Preoperative oral carbohydrate therapy. Curr Opin Anaesthesiol. 2015 Jun;28(3):364-9. doi: 10.1097/ACO.0000000000000192.
- BackgroundSurgery Branch of Chinese Medical Association, Anesthesiology Branch of Chinese Medical Society. Chinese Expert Consensus and Path Management Guidelines for Accelerating Rehabilitation Surgery (2018) [J]. Chinese Journal of Anesthesiology, 2018,38 (001): 8-13.
- Background: PubMed 27840308Yang R, Tao W, Chen YY, Zhang BH, Tang JM, Zhong S, Chen XX. Enhanced recovery after surgery programs versus traditional perioperative care in laparoscopic hepatectomy: A meta-analysis. Int J Surg. 2016 Dec;36(Pt A):274-282. doi: 10.1016/j.ijsu.2016.11.017. Epub 2016 Nov 10.
- BackgroundBethune Orthopaedic Accelerated Rehabilitation Alliance, Bethune Charity Foundation Orthopaedic Professional Committee of trauma, Joint Surgery Professional Committee of Bethune Charity Foundation, etc. Guidelines for the management of perioperative fasting fasting in orthopaedic surgery [J]. Chinese Journal of Trauma and Orthopedics, 2019,21 (10): 829-834.
- Background: PubMed 25121931Smith MD, McCall J, Plank L, Herbison GP, Soop M, Nygren J. Preoperative carbohydrate treatment for enhancing recovery after elective surgery. Cochrane Database Syst Rev. 2014 Aug 14;2014(8):CD009161. doi: 10.1002/14651858.CD009161.pub2.
- Background: PubMed 31112338Noba L, Wakefield A. Are carbohydrate drinks more effective than preoperative fasting: A systematic review of randomised controlled trials. J Clin Nurs. 2019 Sep;28(17-18):3096-3116. doi: 10.1111/jocn.14919. Epub 2019 Jun 10.
- Background[9] Wang Cuilan, Huang Yuting, Zeng Qing, et al. Study on postoperative fasting water prohibition time under ERAS concept [J]. Clinical Medical Engineering, 2022,29 (4): 2.
- 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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Early drinking water, Early consumption of carbohydrates and Late feeding group in people with Postoperative Oral Carbohydrates and Postoperative Recovery, run by Hongwei Shi.
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 6 inclusion and 7 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 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Liu Han (18951670163, han_cold.student@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin resistance index at fasting (time frame: 1 day after surgery). 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 NCT05867264, which also lists 9 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 19 May 2023.