Preoperative Administration of Oral Carbohydrate Drink and Postoperative Insulin Resistance

NCT03793036 | Completed DMC

• 1 other identifier: NR01/19
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study compared traditional concept of preoperative fasting before elective open colon surgery and preoperative treatment with carbohydrate oral drink in intention to improve postoperative stress response to surgical procedure. Hypothesis was: preoperative oral carbohydrate drink reduces postoperative insulin resistance, improves insulin sensitivity, reduces postoperative inflammatory response in terms of the value of Glasgow Prognostic Score (GPS) and IL-6, improves postoperative patient's subjective well-being and surgical clinical outcome.

Conditions

Insulin Resistance; Inflammatory Response; Exaggerated Well-Being; Length of Stay

Keywords

fasting; carbohydrate; insulin resistance

Outcome Measures

Primary Outcomes (3)

• The mean change in insulin resistance using computer model Homeostasis model assessment of insulin resistance

  Blood samples were collected to measure serum levels of glucose and serum levels of insulin. Insulin resistance, was calculated according to the equation = \[fasting insulin (µU/ml) x fasting glucose (mmol/L)\] / 22,5 using computer model Homeostasis model assessment of insulin resistance 2 Calculator version 2,2. The value \>1 indicated the presence of resistance to insulin.

  blood samples were taken at 06:00 am on the day of surgery ( basal value), 6 hours post-surgery, at 06.00 am on the first postoperative day and at 06:00 am on the second postoperative day.

• The mean change in Glasgow Prognostic Score (GPS). The GPS was obtained as ratio of serum C-reactive protein/albumin.

  The GPS was calculated as follow: participants with elevated level of C-reactive protein \>10mg/L and albumin \<35 g/L were allocated a score of 2. Participants showing one or neither of these blood chemistry abnormalities were allocated a score 1 or 0.

  blood samples were taken at four time points: at 06:00 am on the day of surgery ( basal value), 6 hours post-surgery, at 06.00 am on the first postoperative day and at 06:00 am on the second postoperative day.

• The mean change in serum level of IL-6

  The concentration of IL-6 in serum has a r.n. 0-5,9 pg/mL.

  blood samples were taken at four time points: at 06:00 am on the day of surgery ( basal value), 6 hours post-surgery, at 06.00 am on the first postoperative day and at 06:00 am on the second postoperative day.

Secondary Outcomes (2)

• The mean change from baseline in participant's subjective well-being score on Visual Analogue Scale

  The assessment of subjective well-being and pain score was performed immediately before induction into anesthesia and then repeated for 0-4, 4-8, 8-12 and 12-24 hours post-surgery

• surgical clinical outcomes

  from 24 hours post-surgey from apprroximately 10 days post-surgery

Study Arms (2)

FAST group

NO INTERVENTION

preoperative fasting

CHO group

EXPERIMENTAL

preoperative nutrition The participants of experimental group received 400 mil of a clear carbohydrate drink (12,5 gr/100 mil carbohydrate, 50 kcal/100ml, pH 5.0) at 10:00 pm the evening before surgery and another 200 mil of the carbohydrate drink on the day of surgery, 2 hours before induction of anesthesia. After surgery the participants fasted until the recovery of function of the bowel.

Dietary Supplement: preoperative nutrition

Interventions

preoperative nutrition DIETARY_SUPPLEMENT

The participants of experimental group received 400 mil of a clear carbohydrate drink (12,5 gr/100 mil carbohydrate, 50 kcal/100ml, pH 5.0) at 10:00 pm the evening before surgery and another 200 mil of the carbohydrate drink on the day of surgery, 2 hours before induction of anesthesia. After surgery the participants fasted until the recovery of function of the bowel.

CHO group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• participants with ASA physical status class I-II
• aged between 18 years and 70 years
• participants scheduled for elective open colon surgery

You may not qualify if:

• previous treatment of colon or any other cancer
• disseminated malignant disease
• gastro-oesophageal reflux or increased risk of aspiration
• body mass index below 20 and above 30 kg/m2
• overall score ≥3 after final assessment of the nutritional status according to Nutritional Risk Screening 2002 (NRS-2002)
• emergency colon surgery
• diabetes mellitus
• inflammatory bowel disease
• immunological therapy
• cardiopulmonary disease
• neuromusular disease
• renal disease
• hepatic or endocrine disease
• pregnancy
• mental disease

Sponsors & Collaborators

• Nermina Rizvanović: lead

Study Sites (1)

Cantonal Hospital Zenica

Zenica, 72 000, Bosnia and Herzegovina

Location

Related Publications (29)

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  PMID: 24670343 BACKGROUND

• Scott MJ, Baldini G, Fearon KC, Feldheiser A, Feldman LS, Gan TJ, Ljungqvist O, Lobo DN, Rockall TA, Schricker T, Carli F. Enhanced Recovery After Surgery (ERAS) for gastrointestinal surgery, part 1: pathophysiological considerations. Acta Anaesthesiol Scand. 2015 Nov;59(10):1212-31. doi: 10.1111/aas.12601. Epub 2015 Sep 8.

  PMID: 26346577 RESULT

• Ljungqvist O. Jonathan E. Rhoads lecture 2011: Insulin resistance and enhanced recovery after surgery. JPEN J Parenter Enteral Nutr. 2012 Jul;36(4):389-98. doi: 10.1177/0148607112445580. Epub 2012 May 10.

  PMID: 22577121 RESULT

• Akbarzadeh M, Eftekhari MH, Shafa M, Alipour S, Hassanzadeh J. Effects of a New Metabolic Conditioning Supplement on Perioperative Metabolic Stress and Clinical Outcomes: A Randomized, Placebo-Controlled Trial. Iran Red Crescent Med J. 2016 Jan 9;18(1):e26207. doi: 10.5812/ircmj.26207. eCollection 2016 Jan.

  PMID: 26889394 RESULT

• Witasp A, Nordfors L, Schalling M, Nygren J, Ljungqvist O, Thorell A. Expression of inflammatory and insulin signaling genes in adipose tissue in response to elective surgery. J Clin Endocrinol Metab. 2010 Jul;95(7):3460-9. doi: 10.1210/jc.2009-2588. Epub 2010 May 5.

  PMID: 20444921 RESULT

• 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.

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• Gomes de Lima KV, Maio R. Nutritional status, systemic inflammation and prognosis of patients with gastrointestinal cancer. Nutr Hosp. 2012 May-Jun;27(3):707-14. doi: 10.3305/nh/2012.27.3.5567.

  PMID: 23114934 RESULT

• Ishizuka M, Nagata H, Takagi K, Iwasaki Y, Shibuya N, Kubota K. Clinical Significance of the C-Reactive Protein to Albumin Ratio for Survival After Surgery for Colorectal Cancer. Ann Surg Oncol. 2016 Mar;23(3):900-7. doi: 10.1245/s10434-015-4948-7. Epub 2015 Nov 3.

  PMID: 26530445 RESULT

• Perrone F, da-Silva-Filho AC, Adorno IF, Anabuki NT, Leal FS, Colombo T, da Silva BD, Dock-Nascimento DB, Damiao A, de Aguilar-Nascimento JE. Effects of preoperative feeding with a whey protein plus carbohydrate drink on the acute phase response and insulin resistance. A randomized trial. Nutr J. 2011 Jun 13;10:66. doi: 10.1186/1475-2891-10-66.

  PMID: 21668975 RESULT

• Nygren J. The metabolic effects of fasting and surgery. Best Pract Res Clin Anaesthesiol. 2006 Sep;20(3):429-38. doi: 10.1016/j.bpa.2006.02.004.

  PMID: 17080694 RESULT

• Kratzing C. Pre-operative nutrition and carbohydrate loading. Proc Nutr Soc. 2011 Aug;70(3):311-5. doi: 10.1017/S0029665111000450.

  PMID: 21781358 RESULT

• Sada F, Krasniqi A, Hamza A, Gecaj-Gashi A, Bicaj B, Kavaja F. A randomized trial of preoperative oral carbohydrates in abdominal surgery. BMC Anesthesiol. 2014 Oct 17;14:93. doi: 10.1186/1471-2253-14-93. eCollection 2014.

  PMID: 25364300 RESULT

• Gianotti L, Biffi R, Sandini M, Marrelli D, Vignali A, Caccialanza R, Vigano J, Sabbatini A, Di Mare G, Alessiani M, Antomarchi F, Valsecchi MG, Bernasconi DP. Preoperative Oral Carbohydrate Load Versus Placebo in Major Elective Abdominal Surgery (PROCY): A Randomized, Placebo-controlled, Multicenter, Phase III Trial. Ann Surg. 2018 Apr;267(4):623-630. doi: 10.1097/SLA.0000000000002325.

  PMID: 28582271 RESULT

• 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.

  PMID: 23052794 RESULT

• Amer MA, Smith MD, Herbison GP, Plank LD, McCall JL. Network meta-analysis of the effect of preoperative carbohydrate loading on recovery after elective surgery. Br J Surg. 2017 Feb;104(3):187-197. doi: 10.1002/bjs.10408. Epub 2016 Dec 21.

  PMID: 28000931 RESULT

• Sarin A, Chen LL, Wick EC. Enhanced recovery after surgery-Preoperative fasting and glucose loading-A review. J Surg Oncol. 2017 Oct;116(5):578-582. doi: 10.1002/jso.24810. Epub 2017 Aug 28.

  PMID: 28846137 RESULT

• 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.

  PMID: 25121931 RESULT

• Kang ZQ, Huo JL, Zhai XJ. Effects of perioperative tight glycemic control on postoperative outcomes: a meta-analysis. Endocr Connect. 2018 Dec 1;7(12):R316-R327. doi: 10.1530/EC-18-0231.

  PMID: 30120204 RESULT

• Gillis C, Carli F. Promoting Perioperative Metabolic and Nutritional Care. Anesthesiology. 2015 Dec;123(6):1455-72. doi: 10.1097/ALN.0000000000000795.

  PMID: 26248016 RESULT

• Pinto Ados S, Grigoletti SS, Marcadenti A. Fasting abbreviation among patients submitted to oncologic surgery: systematic review. Arq Bras Cir Dig. 2015;28(1):70-3. doi: 10.1590/S0102-67202015000100018.

  PMID: 25861075 RESULT

• Tamura T, Yatabe T, Kitagawa H, Yamashita K, Hanazaki K, Yokoyama M. Oral carbohydrate loading with 18% carbohydrate beverage alleviates insulin resistance. Asia Pac J Clin Nutr. 2013;22(1):48-53. doi: 10.6133/apjcn.2013.22.1.20.

  PMID: 23353610 RESULT

• Pexe-Machado PA, de Oliveira BD, Dock-Nascimento DB, de Aguilar-Nascimento JE. Shrinking preoperative fast time with maltodextrin and protein hydrolysate in gastrointestinal resections due to cancer. Nutrition. 2013 Jul-Aug;29(7-8):1054-9. doi: 10.1016/j.nut.2013.02.003.

  PMID: 23759267 RESULT

• Feng J, Li K, Li L, Wang X, Huang M, Yang J, Hu Y. The effects of fast-track surgery on inflammation and immunity in patients undergoing colorectal surgery. Int J Colorectal Dis. 2016 Oct;31(10):1675-82. doi: 10.1007/s00384-016-2630-6. Epub 2016 Aug 12.

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• Barbic J, Ivic D, Alkhamis T, Drenjancevic D, Ivic J, Harsanji-Drenjancevic I, Turina I, Vcev A. Kinetics of changes in serum concentrations of procalcitonin, interleukin-6, and C- reactive protein after elective abdominal surgery. Can it be used to detect postoperative complications? Coll Antropol. 2013 Mar;37(1):195-201.

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• Weimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale R, Waitzberg DL, Bischoff SC, Singer P. ESPEN guideline: Clinical nutrition in surgery. Clin Nutr. 2017 Jun;36(3):623-650. doi: 10.1016/j.clnu.2017.02.013. Epub 2017 Mar 7.

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• 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.

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• Burgess LC, Phillips SM, Wainwright TW. What Is the Role of Nutritional Supplements in Support of Total Hip Replacement and Total Knee Replacement Surgeries? A Systematic Review. Nutrients. 2018 Jun 25;10(7):820. doi: 10.3390/nu10070820.

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• 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.

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MeSH Terms

Conditions

Insulin Resistance; Fasting

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Feeding Behavior; Behavior

Study Officials

• Nermina Rizvanović, MD

  Cantonal Hospital Zenica, Crkvice 67, 72 000 Zenica, Bosnia and Herzegovina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Surgeons, anesthetists, and outcome assessors were masking to the treatment allocation. Masking was possible because group allocation was performed by a nurse from the surgical ward, and the attending surgeon and anesthetist welcomed the participants at the operating room the next morning without knowledge of the type of intervention. The outcome study were evaluated by independent assessors who were also masked because they evaluated patients after surgery on a daily base during hospital stay without knowledge of the type intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD Anesthesiology and Intensive Care Specialist

Model Details: The diagnostic protocol for colon cancer was performed in patients at the surgery department. The patients with diagnosed colon tumor were prepared for the surgical procedure. After that, patients were examined to a preoperative anesthetic visit. During the visit, participants were assessed according to eligibility for enrollment in the study. The participants who have met the eligibility criteria have explained the nature of the study protocol. Those who agreed to participate in the study were randomized to one of two study groups for the duration of the study.

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 4, 2019
• Study Start: May 1, 2018
• Primary Completion: December 20, 2018
• Study Completion: December 31, 2018
• Last Updated: January 7, 2019

Record last verified: 2019-01

Locations

BO (1)