AzTrials
AzTrials

Type 2 Diabetes MellitusCARB-DMNCT07451015

Preoperative Carbohydrate Loading in Diabetic Patients Undergoing Elective Abdominal Surgery

A study testing Standard Preoperative Fasting With Water and Preoperative Oral Carbohydrate Loading in people with Type 2 Diabetes Mellitus and Elective Abdominal Surgery, run by Tanta University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 21 to 65 years
What is being tested?
Standard Preoperative Fasting With Water and Preoperative Oral Carbohydrate Loading
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteEgypt
Study dates
1 Jun 2024to 1 Dec 2025
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Tanta University Hospitals

    Tanta, Gharbia Governorate

Other trials in Egypt

About this study

Official title: "A Randomized Controlled Trial on the Effect of Preoperative Carbohydrate Loading in Diabetic and Non-Diabetic Patients Undergoing Elective Abdominal Surgery"

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.

Read the detailed description

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.

Being tested
Standard Preoperative Fasting With Water, Preoperative Oral Carbohydrate Loading
Keywords
Preoperative carbohydrate loading, ERAS, gastric residual volume, gastric ultrasound, perioperative glycemic control
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard Preoperative Fasting With WaterBehavioural

    Also called Routine fasting protocol

    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.

  • Preoperative Oral Carbohydrate LoadingBehavioural

    Also called Oral carbohydrate drink

    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.

Study groups in NCT07451015
Study groupRoleWhat they receive
Group I - Nondiabetic ControlPlacebo comparatorYogurt + honey at midnight, 200 ml water 2h pre-op
Receives: Behavioral: Standard Preoperative Fasting With Water
Group II - Nondiabetic CHOActive comparatorYogurt + honey at midnight, 200 ml carbohydrate drink 2h pre-op
Receives: Behavioral: Preoperative Oral Carbohydrate Loading
Group III - Diabetic CHOActive comparatorYogurt + honey at midnight, 200 ml carbohydrate drink 2h pre-op
Receives: Behavioral: Preoperative Oral Carbohydrate Loading

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Preoperative (immediately before induction of anesthesia)

Secondary outcomes (5)

  1. 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.

    Measured: Postoperative period (within 24 hours after surgery)

  2. Perioperative Random Blood Glucose Levels

    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.

    Measured: Preoperative and 6 hours after carbohydrate loading

  3. Incidence of Postoperative Nausea and Vomiting (PONV)

    Occurrence of nausea and/or vomiting within the first 24 hours after surgery.

    Measured: Within 24 hours postoperatively

  4. Length of Hospital Stay

    Total number of days from surgery until hospital discharge.

    Measured: From surgery until discharge (up to 7 days)

  5. Time to Independent Ambulation

    Time required for the patient to achieve independent ambulation following surgery.

    Measured: Within the first 48 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2026
  2. Study start1 Jun 2024
  3. Primary completion1 Jun 2025
  4. Study completion1 Dec 2025

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07451015
Sponsor's protocol ID
TUH-ANES-CARB-DM-2024-01
Acronym
CARB-DM
Status last verified
Mar 2026
First submitted
27 Feb 2026
Last updated
9 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 27485861

  • 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.

    PubMed 34221937

  • 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.

    PubMed 35663207

  • 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.

    PubMed 24893784

  • 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.

    PubMed 3754372

  • 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.

    PubMed 38149347

  • 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.

    PubMed 34620304

  • 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.

    PubMed 16095440

  • 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.

    PubMed 38143683

  • 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.

    PubMed 36937339

  • 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.

    PubMed 22648738

  • 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.

    PubMed 27152296

  • 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.

    PubMed 23052794

  • 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.

    PubMed 23200124

Questions about this trial

What is this clinical trial studying?

A study testing Standard Preoperative Fasting With Water and Preoperative Oral Carbohydrate Loading in people with Type 2 Diabetes Mellitus and Elective Abdominal Surgery, 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 9 Mar 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preoperative Gastric Residual Volume Measured by Ultrasound (time frame: Preoperative (immediately before induction of anesthesia)). 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 NCT07451015, which also lists 14 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 9 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in