Carbohydrate Ingestion Prior to Surgery (CIPS)

NCT06057532 | Active Not Recruiting

• 1 other identifier: STUDY00150605
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to determine the impact of taking a specialized form of carbohydrate in the immediate preoperative period on metabolic markers, surgical outcomes and patient health. Patients will be randomized to receive a specialized sports drink or a standard sports drink. Patients will have a continuous glucose monitor (CGM) placed on their upper arm to measure glucose throughout surgery and during the post-operative period.

Conditions

Urologic Surgical Procedures; Carbohydrate Loading; Preoperative Care

Keywords

Urologic Surgery; Preoperative Care; Carbohydrate Loading; Continuous glucose monitor

Outcome Measures

Primary Outcomes (2)

• Compare perioperative glycemic variability between study arms

  Differences in blood glucose, insulin, free fatty acids will be compared

  From up to 5 days before surgery to up to 4 days after surgery.

• Compare perioperative clinical outcomes after surgery between study arms

  Differences in post-operative complications within 30 days after surgery, length of hospital stay, post-operative infections, and number of patients needing intraoperative or postoperative insulin treatment will be be compared between study arms.

  From surgery to 90 days after surgery.

Study Arms (2)

UCAN SuperStarch study drinks

EXPERIMENTAL

Intervention group will receive UCAN SuperStarch study drinks. 100g carbohydrate will be consumed the night before surgery and 50g carbohydrate will be consumed 2 - 3 hours before surgery.

Dietary Supplement: UCAN SuperStarch

Gatorade study drinks

ACTIVE COMPARATOR

Active Control group will receive Gatorade study drinks. 100g carbohydrate will be consumed the night before surgery and 50g carbohydrate will be consumed 2 - 3 hours before surgery.

Dietary Supplement: Gatorade

Interventions

UCAN SuperStarch DIETARY_SUPPLEMENT

Intervention patients will have a continuous glucose monitor placed on their upper arm by the study team 1 - 5 days prior to surgery. These patients will drink the intervention study drink and record information about how they feel before and after consumption.

UCAN SuperStarch study drinks

Gatorade DIETARY_SUPPLEMENT

Active control patients will have a continuous glucose monitor placed on their upper arm by the study team 1 - 5 days prior to surgery. These patients will drink the active control study drink and record information about how they feel before and after consumption.

Gatorade study drinks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults, at least 18 years old,
• undergoing major urologic surgery (proposed duration more than 4 hours),
• must be able to swallow liquid,
• must speak English.

You may not qualify if:

• diagnosis of Type 1 or 2 diabetes mellitus
• A1C of 6.5% or higher
• pregnant or lactating
• known allergy to milk, soy, egg, wheat, peanuts, tree nut,
• swallowing difficulties

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Health System

Kansas City, Kansas, 66160, United States

Location

Related Publications (11)

• Dobson GP. Trauma of major surgery: A global problem that is not going away. Int J Surg. 2020 Sep;81:47-54. doi: 10.1016/j.ijsu.2020.07.017. Epub 2020 Jul 29.

  PMID: 32738546 BACKGROUND

• Cheng H, Clymer JW, Po-Han Chen B, Sadeghirad B, Ferko NC, Cameron CG, Hinoul P. Prolonged operative duration is associated with complications: a systematic review and meta-analysis. J Surg Res. 2018 Sep;229:134-144. doi: 10.1016/j.jss.2018.03.022. Epub 2018 Apr 24.

  PMID: 29936980 BACKGROUND

• Thorell A, Loftenius A, Andersson B, Ljungqvist O. Postoperative insulin resistance and circulating concentrations of stress hormones and cytokines. Clin Nutr. 1996 Apr;15(2):75-9. doi: 10.1016/s0261-5614(96)80023-9.

  PMID: 16844002 BACKGROUND

• Kielhorn BA, Senagore AJ, Asgeirsson T. The benefits of a low dose complex carbohydrate/citrulline electrolyte solution for preoperative carbohydrate loading: Focus on glycemic variability. Am J Surg. 2018 Mar;215(3):373-376. doi: 10.1016/j.amjsurg.2017.10.029. Epub 2017 Nov 8.

  PMID: 29128103 BACKGROUND

• Ackerman RS, Tufts CW, DePinto DG, Chen J, Altshuler JR, Serdiuk A, Cohen JB, Patel SY. How Sweet Is This? A Review and Evaluation of Preoperative Carbohydrate Loading in the Enhanced Recovery After Surgery Model. Nutr Clin Pract. 2020 Apr;35(2):246-253. doi: 10.1002/ncp.10427. Epub 2019 Oct 21.

  PMID: 31637778 BACKGROUND

• Nygren J, Soop M, Thorell A, Sree Nair K, Ljungqvist O. Preoperative oral carbohydrates and postoperative insulin resistance. Clin Nutr. 1999 Apr;18(2):117-20. doi: 10.1054/clnu.1998.0019.

  PMID: 10459075 BACKGROUND

• Hausel J, Nygren J, Lagerkranser M, Hellstrom PM, Hammarqvist F, Almstrom C, Lindh A, Thorell A, Ljungqvist O. A carbohydrate-rich drink reduces preoperative discomfort in elective surgery patients. Anesth Analg. 2001 Nov;93(5):1344-50. doi: 10.1097/00000539-200111000-00063.

  PMID: 11682427 BACKGROUND

• MENDELSON CL. The aspiration of stomach contents into the lungs during obstetric anesthesia. Am J Obstet Gynecol. 1946 Aug;52:191-205. doi: 10.1016/s0002-9378(16)39829-5. No abstract available.

  PMID: 20993766 BACKGROUND

• Wischmeyer PE, Carli F, Evans DC, Guilbert S, Kozar R, Pryor A, Thiele RH, Everett S, Grocott M, Gan TJ, Shaw AD, Thacker JKM, Miller TE, Hedrick TL, McEvoy MD, Mythen MG, Bergamaschi R, Gupta R, Holubar SD, Senagore AJ, Abola RE, Bennett-Guerrero E, Kent ML, Feldman LS, Fiore JF Jr; Perioperative Quality Initiative (POQI) 2 Workgroup. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Nutrition Screening and Therapy Within a Surgical Enhanced Recovery Pathway. Anesth Analg. 2018 Jun;126(6):1883-1895. doi: 10.1213/ANE.0000000000002743.

  PMID: 29369092 BACKGROUND

• Joshi GP, Abdelmalak BB, Weigel WA, Harbell MW, Kuo CI, Soriano SG, Stricker PA, Tipton T, Grant MD, Marbella AM, Agarkar M, Blanck JF, Domino KB. 2023 American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting: Carbohydrate-containing Clear Liquids with or without Protein, Chewing Gum, and Pediatric Fasting Duration-A Modular Update of the 2017 American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting. Anesthesiology. 2023 Feb 1;138(2):132-151. doi: 10.1097/ALN.0000000000004381.

  PMID: 36629465 BACKGROUND

• Colebatch E, Lockwood C. Enhanced perioperative nutritional care for patients undergoing elective colorectal surgery at Calvary North Adelaide Hospital: a best practice implementation project. JBI Evid Synth. 2020 Jan;18(1):224-242. doi: 10.11124/JBISRIR-2017-003994.

  PMID: 31290790 BACKGROUND

MeSH Terms

Interventions

gatorade

Study Officials

• Jill M Hamilton-Reeves, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study drink powders will be measured and assigned a code by study staff that will not dispense the study drink powders to participants.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study is a randomized, double-blinded, clinical trial that will provide a starch or standard sports drink at least 2 hours before surgery to evaluate perioperative glycemic variability. Patients will be randomized and have a 50/50 chance of getting one of the two drinks being studied.

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: September 28, 2023
• Study Start: November 5, 2023
• Primary Completion: August 15, 2025
• Study Completion (Estimated): November 15, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)