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This study evaluates the effect of preoperative carbohydrate loading on early postoperative recovery in patients with type 2 diabetes mellitus undergoing elective abdominal surgery. Traditionally, patients fast before surgery, which can increase insulin resistance, delay recovery, and worsen postoperative outcomes. Preoperative carbohydrate drinks may reduce surgical stress and improve recovery, but concerns exist regarding blood glucose control and gastric emptying in diabetic patients.
In this randomized, double-blind clinical trial, 120 eligible patients will be assigned to three groups: nondiabetic control, nondiabetic with carbohydrate load, and diabetic with carbohydrate load. Patients will receive either a carbohydrate-rich drink or control solution before surgery. Preoperative gastric residual volume will be measured using ultrasound to assess aspiration risk. Blood glucose levels will be measured before and after carbohydrate intake. Postoperative outcomes including metabolic and inflammatory response, nausea and vomiting, length of hospital stay, and time to independent ambulation will be recorded.
The study aims to determine whether preoperative carbohydrate loading is safe and beneficial for diabetic patients undergoing elective abdominal surgery.
This prospective randomized controlled double-blinded study will be conducted at Tanta University Hospitals from June 2024 to June 2025. A total of 120 adult patients (aged 21-65 years, ASA I-II) undergoing elective abdominal surgery will be enrolled. Patients will be randomly assigned to one of three groups: nondiabetic control, nondiabetic carbohydrate load, or diabetic carbohydrate load.
The primary outcome is preoperative gastric residual volume measured by ultrasound. Secondary outcomes include postoperative metabolic and inflammatory response, perioperative blood glucose levels, incidence of nausea and vomiting, length of hospital stay, and time to independent ambulation.
Patients will receive a standardized preoperative meal of yogurt and honey at midnight, with either a clear carbohydrate drink or water administered two hours before anesthesia induction. Gastric ultrasound will be performed pre-induction to assess aspiration risk. Standard general anesthesia protocols will be used, and all patients will be monitored perioperatively.
Ethical approval has been obtained, and informed consent will be collected from all participants. Data confidentiality and patient privacy will be strictly maintained.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I - Nondiabetic Control | Placebo Comparator | Yogurt + honey at midnight, 200 ml water 2h pre-op |
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| Group II - Nondiabetic CHO | Active Comparator | Yogurt + honey at midnight, 200 ml carbohydrate drink 2h pre-op |
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| Group III - Diabetic CHO | Active Comparator | Yogurt + honey at midnight, 200 ml carbohydrate drink 2h pre-op |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Preoperative Fasting With Water | Behavioral | Participants receive 100 ml yogurt mixed with approximately 42 g honey at midnight before surgery. Two hours before induction of anesthesia, they receive 200 ml of clear water. No carbohydrate-rich clear drink is administered preoperatively. This represents the standard preoperative fasting protocol used in the control group. |
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative Gastric Residual Volume Measured by Ultrasound | Gastric residual volume (GRV) will be assessed preoperatively using gastric ultrasound examination in the right lateral position. Cross-sectional area measurements will be used to calculate gastric volume using a validated formula. This outcome evaluates gastric emptying and aspiration risk prior to anesthesia induction. | Preoperative (immediately before induction of anesthesia) |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Metabolic and Inflammatory Response (Glasgow Prognostic Score) | The postoperative inflammatory and metabolic response will be assessed using the Glasgow Prognostic Score (GPS), based on C-reactive protein and serum albumin levels. | Postoperative period (within 24 hours after surgery) |
| Perioperative Random Blood Glucose Levels |
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Inclusion Criteria:
Adults aged 21-65 years
Both males and females
American Society of Anesthesiologists (ASA) physical status I-II
Scheduled for elective abdominal surgery under general anesthesia
Able and willing to provide informed consent
Exclusion Criteria:
Patient refusal
Known liver or renal pathology affecting gastric function
Mental dysfunction or cognitive disorders impairing consent or cooperation
Increased risk of gastric content aspiration
Body mass index (BMI) < 20 or > 35 kg/m²
Prior upper gastrointestinal surgery
Use of medications affecting gastric motility
Type 1 diabetes mellitus
Type 2 diabetes mellitus treated with insulin
Patients with clinical evidence of diabetic gastropathy or autonomic dysfunction
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University Hospitals | Tanta | Gharbia Governorate | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27485861 | Background | Costa MD, Vieira de Melo CY, Amorim AC, Cipriano Torres Dde O, Dos Santos AC. Association Between Nutritional Status, Inflammatory Condition, and Prognostic Indexes with Postoperative Complications and Clinical Outcome of Patients with Gastrointestinal Neoplasia. Nutr Cancer. 2016 Oct;68(7):1108-14. doi: 10.1080/01635581.2016.1206578. Epub 2016 Aug 2. | |
| 34221937 |
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De-identified individual participant data, including demographic, laboratory, and outcome measures, will be made available to qualified researchers upon reasonable request. Data will be shared through secure institutional channels after publication of the primary results. A data use agreement will be required to ensure participant confidentiality.
De-identified individual participant data and supporting documents will be available beginning 6 months after publication of the primary results, and will remain available for 3 years thereafter.
Data will be accessible to qualified researchers for academic and scientific purposes. Requests must include a research proposal and a signed data use agreement to ensure confidentiality. Access will be provided through secure institutional channels upon approval of the request. Shared data will include de-identified participant-level data, the study protocol, statistical analysis plan, informed consent form, and analytic code.
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| Preoperative Oral Carbohydrate Loading | Behavioral | Participants receive 100 ml yogurt mixed with approximately 42 g honey at midnight before surgery. Two hours before induction of anesthesia, they receive 200 ml of a clear carbohydrate drink consisting of 200 ml water with two spoonfuls (approximately 42 g) of honey dissolved. This intervention is administered preoperatively to reduce perioperative insulin resistance and improve metabolic response. |
|
|
Random blood glucose (RBG) levels will be measured at three time points: before carbohydrate loading, 2 hours pre-induction, and 6 hours after carbohydrate administration. |
| Preoperative and 6 hours after carbohydrate loading |
| Incidence of Postoperative Nausea and Vomiting (PONV) | Occurrence of nausea and/or vomiting within the first 24 hours after surgery. | Within 24 hours postoperatively |
| Length of Hospital Stay | Total number of days from surgery until hospital discharge. | From surgery until discharge (up to 7 days) |
| Time to Independent Ambulation | Time required for the patient to achieve independent ambulation following surgery. | Within the first 48 hours postoperatively |
| Mohammad Khalil A, Gaber Ragab S, Makram Botros J, Ali Abd-Aal H, Labib Boules M. Gastric Residual Volume Assessment by Gastric Ultrasound in Fasting Obese Patients: A Comparative Study. Anesth Pain Med. 2021 Feb 3;11(1):e109732. doi: 10.5812/aapm.109732. eCollection 2021 Feb. |
| 35663207 | Background | Khandekar SS, Doctor JR, Awaskar SK, Alex NK, Medha LR, Ranganathan P. Ultrasound-guided estimation of gastric residual volume using Perlas's formula: A validation study in patients. Indian J Anaesth. 2022 Apr;66(4):255-259. doi: 10.4103/ija.ija_783_21. Epub 2022 Apr 20. |
| 24893784 | Background | Van de Putte P, Perlas A. Ultrasound assessment of gastric content and volume. Br J Anaesth. 2014 Jul;113(1):12-22. doi: 10.1093/bja/aeu151. Epub 2014 Jun 3. |
| 3754372 | Background | Olsson GL, Hallen B, Hambraeus-Jonzon K. Aspiration during anaesthesia: a computer-aided study of 185,358 anaesthetics. Acta Anaesthesiol Scand. 1986 Jan;30(1):84-92. doi: 10.1111/j.1399-6576.1986.tb02373.x. |
| 38149347 | Background | Srinivasareddy S. Gastric Ultrasound for Gastric Content Evaluation. Turk J Anaesthesiol Reanim. 2023 Dec 27;51(6):465-469. doi: 10.4274/TJAR.2023.231479. |
| 34620304 | Background | Robinson KN, Cassady BA, Hegazi RA, Wischmeyer PE. Preoperative carbohydrate loading in surgical patients with type 2 diabetes: Are concerns supported by data? Clin Nutr ESPEN. 2021 Oct;45:1-8. doi: 10.1016/j.clnesp.2021.08.023. Epub 2021 Sep 3. |
| 16095440 | Background | Soreide E, Eriksson LI, Hirlekar G, Eriksson H, Henneberg SW, Sandin R, Raeder J; (Task Force on Scandinavian Pre-operative Fasting Guidelines, Clinical Practice Committee Scandinavian Society of Anaesthesiology and Intensive Care Medicine). Pre-operative fasting guidelines: an update. Acta Anaesthesiol Scand. 2005 Sep;49(8):1041-7. doi: 10.1111/j.1399-6576.2005.00781.x. |
| 38143683 | Background | Vishak M, Gayathri B, Chandrasekhar G, Ramani S. Randomized Controlled Trial Comparing the Effects of Preoperative Carbohydrate and Non-carbohydrate Loading on Gastric Emptying in Diabetic and Non-diabetic Patients Posted for Elective Surgery. Cureus. 2023 Nov 21;15(11):e49213. doi: 10.7759/cureus.49213. eCollection 2023 Nov. |
| 36937339 | Background | Tian F, Zhou X, Wang J, Wang M, Shang Z, Li L, Jing C, Chen Y. Intravenous dexamethasone administration during anesthesia induction can improve postoperative nutritional tolerance of patients following elective gastrointestinal surgery: A post-hoc analysis. Front Nutr. 2023 Mar 2;10:1093662. doi: 10.3389/fnut.2023.1093662. eCollection 2023. |
| 22648738 | Background | Phillips BE, Smith K, Liptrot S, Atherton PJ, Varadhan K, Rennie MJ, Larvin M, Lund JN, Williams JP. Effect of colon cancer and surgical resection on skeletal muscle mitochondrial enzyme activity in colon cancer patients: a pilot study. J Cachexia Sarcopenia Muscle. 2013 Mar;4(1):71-7. doi: 10.1007/s13539-012-0073-7. Epub 2012 May 31. |
| 27152296 | Background | Choi WJ, Kim J. Nutritional Care of Gastric Cancer Patients with Clinical Outcomes and Complications: A Review. Clin Nutr Res. 2016 Apr;5(2):65-78. doi: 10.7762/cnr.2016.5.2.65. Epub 2016 Apr 30. |
| 23052794 | Background | Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, Macfie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS((R))) Society recommendations. World J Surg. 2013 Feb;37(2):259-84. doi: 10.1007/s00268-012-1772-0. No abstract available. |
| 23200124 | Result | Awad S, Varadhan KK, Ljungqvist O, Lobo DN. A meta-analysis of randomised controlled trials on preoperative oral carbohydrate treatment in elective surgery. Clin Nutr. 2013 Feb;32(1):34-44. doi: 10.1016/j.clnu.2012.10.011. Epub 2012 Nov 7. |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D014867 | Water |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
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