Insulin Resistance Clinical Trial
— Kel-LoadOfficial title:
The Use of Kelulut Honey for Carbohydrate-Loading in the Preoperative Period for Patients Undergoing Abdominal Surgery Involving the Digestive System as Part of Enhanced Recovery After Surgery as Opposed to VALENS® Carborie®Load
NCT number | NCT04438590 |
Other study ID # | USMKK |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 1, 2020 |
Est. completion date | November 30, 2021 |
Verified date | December 2021 |
Source | Universiti Sains Malaysia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study aims to identify if Kelulut Honey can be a potential alternative for the use of preoperative carboloading instead of the commercially available product, Carborie.
Status | Completed |
Enrollment | 64 |
Est. completion date | November 30, 2021 |
Est. primary completion date | September 25, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria - Adult (Age = 18) - Elective Surgery with Intraabdominal Involvement Exclusion Criteria - Known Diabetics - Fasting Glucose Level > 7 mmol/L - ASA > 3 - On Steroid Treatment - Recent Infection Past 3 Months - Preoperative Unintentional Weight Loss >10% of usual body weight within 6 months - Emergency Surgery - Minor (Age < 18) |
Country | Name | City | State |
---|---|---|---|
Malaysia | Hospital Universiti Sains Malaysia | Kubang Kerian | Kelantan |
Lead Sponsor | Collaborator |
---|---|
Universiti Sains Malaysia |
Malaysia,
Abdul JA, et al., Surgical Services In Malaysian Hospitals. National Healthcare Establishment & Workforce Statistics (NHEWS) 2011, NCRC/HSU/2013.1 C4:47-63, 2013
Bilku DK, Dennison AR, Hall TC, Metcalfe MS, Garcea G. Role of preoperative carbohydrate loading: a systematic review. Ann R Coll Surg Engl. 2014 Jan;96(1):15-22. doi: 10.1308/003588414X13824511650614. Review. — View Citation
Gianotti L, Biffi R, Sandini M, Marrelli D, Vignali A, Caccialanza R, Viganò 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): — View Citation
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 Societ — View Citation
Kratzing C. Pre-operative nutrition and carbohydrate loading. Proc Nutr Soc. 2011 Aug;70(3):311-5. doi: 10.1017/S0029665111000450. Review. — View Citation
Lassen K, Soop M, Nygren J, Cox PB, Hendry PO, Spies C, von Meyenfeldt MF, Fearon KC, Revhaug A, Norderval S, Ljungqvist O, Lobo DN, Dejong CH; Enhanced Recovery After Surgery (ERAS) Group. Consensus review of optimal perioperative care in colorectal surg — View Citation
Liz Goldenberg., Fasting versus Carb-Loading: What's the Evidence for Your Enhanced Recovery after Bariatric Surgery Program?, Bariatric Times. 2018;15(11):28-29
Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952. Review. — View Citation
Maitra S, Kirtania J, Pal S, Bhattacharjee S, Layek A, Ray S. Intraoperative blood glucose levels in nondiabetic patients undergoing elective major surgery under general anaesthesia receiving different crystalloid solutions for maintenance fluid. Anesth E — View Citation
Mustafa MZ, Yaacob NS, Sulaiman SA. Reinventing the Honey Industry: Opportunities of the Stingless Bee. Malays J Med Sci. 2018 Jul;25(4):1-5. doi: 10.21315/mjms2018.25.4.1. Epub 2018 Aug 30. — View Citation
Nakamura M, Uchida K, Akahane M, Watanabe Y, Ohtomo K, Yamada Y. The effects on gastric emptying and carbohydrate loading of an oral nutritional supplement and an oral rehydration solution: a crossover study with magnetic resonance imaging. Anesth Analg. — View Citation
Scott MJ, Fawcett WJ. Oral carbohydrate preload drink for major surgery - the first steps from famine to feast. Anaesthesia. 2014 Dec;69(12):1308-13. doi: 10.1111/anae.12921. Epub 2014 Oct 23. — View Citation
Sudiyatmo, et al., Effects of Preoperative Honey Drink on Gastric Content, Perioperative Discomfort and Insulin Resistance in Patients Undergoing Open Colorectal Surgery a Randomized, Controlled Trial. British Journal of Medicine & Medical Research, 14(7)
Yagci G, Can MF, Ozturk E, Dag B, Ozgurtas T, Cosar A, Tufan T. Effects of preoperative carbohydrate loading on glucose metabolism and gastric contents in patients undergoing moderate surgery: a randomized, controlled trial. Nutrition. 2008 Mar;24(3):212- — View Citation
Zulkhairi Amin FA, Sabri S, Mohammad SM, Ismail M, Chan KW, Ismail N, Norhaizan ME, Zawawi N. Therapeutic Properties of Stingless Bee Honey in Comparison with European Bee Honey. Adv Pharmacol Sci. 2018 Dec 26;2018:6179596. doi: 10.1155/2018/6179596. eCol — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Kelulut Honey Improves Insulin Resistance when used as carbo-loading preoperatively | • To compare blood sugar levels between patients receiving Kelulut Honey and Carborie pre, intra, and post operatively. | 48 Hours | |
Primary | Kelulut Honey would be completely cleared within 2 hours after consumption when used for carbo-loading preoperatively. | • To compare Residual Gastric Volume between patients receiving Kelulut Honey and Carborie preoperatively. | 2 hours |
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