Effect of Preoperative Oral Carbohydrates on the Glycemic Variability of Diabetic Patients

Preoperative carbohydrate drink intake attenuate insulin resistance. However, carbohydrate loading may compromise blood glucose control in patients with diabetes. There is some evidence that oral carbohydrate loading may be safe in patients with type 2 diabetes. Therefore, the investigators aim to evaluate whether preoperative carbohydrate intake affects insulin resistance and glycemic variability in patients with diabetes. Fifty patients scheduled for total knee arthroplasty will be divided into carbohydrate (n=25) and control (n=25) groups. Randomly selected patients of the carbohydrate group are given 400ml of 12.8 g/100 ml carbohydrate beverage 2-3 hours before their scheduled operation. In contrast, patients in the control group are fasted from water 2 hours before surgery according to standard protocol.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Dietary supplement: carbohydrate group

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1. Patients undergoing total knee arthroplasty

Exclusion Criteria:

• 1. Patients with contraindications to spinal anesthesia (local infection, clotting disorders, anatomical abnormalities, sepsis, etc.)
• 2. Patients with gastroesophageal reflux disease, gastric emptying disorders, inflammatory bowel disease, or previous treatment for intra-abdominal cancer
• 3. Patients with chronic renal disease or severe cardiovascular disease
• 4. HbA1c >69 mmol/mol or BMI >30 kg/m2
• 5. A duration of ≥5 hours between consumption of CHO and initiation of surgery.
• 6. The subject is a foreigner or illiterate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: control group
EXPERIMENTAL: carbohydrate group(CHO group)	Dietary supplement: carbohydrate group; Randomly selected patients of the carbohydrate group are given oral carbohydrate (400ml) 2-3 hours before surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic variability	- Coefficient of glucose variability =SD/mean x 100 (%)	Before anesthesia
Glycemic variability	- J index=0.001 x (MBG +SD)2 mg/dL	Before anesthesia
Glycemic variability	- Coefficient of glucose variability =SD/mean x 100 (%)	immediately after anesthesia
Glycemic variability	- J index=0.001 x (MBG +SD)2 mg/dL	immediately after anesthesia
Glycemic variability	- Coefficient of glucose variability =SD/mean x 100 (%)	operation end
Glycemic variability	- J index=0.001 x (MBG +SD)2 mg/dL	operation end
Glycemic variability	- Coefficient of glucose variability =SD/mean x 100 (%)	1 hour after surgery
Glycemic variability	- J index=0.001 x (MBG +SD)2 mg/dL	1 hour after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin resistance	Insulin resistance index = fasting glucose x fasting insulin/22.5	Before anesthesia
Insulin resistance	serum laboratory test: glucagon	Before anesthesia
Insulin resistance	serum laboratory test: GLP-1	Before anesthesia
Insulin resistance	serum laboratory test: C-peptide	Before anesthesia
Insulin resistance	serum laboratory test: free fatty acid	Before anesthesia
gastric volume	gastric volume measured by ultrasonography.	Before anesthesia
hand grip strength	hand grip strength measured by electronic hand dynamometer	Before anesthesia

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• Soop M, Nygren J, Myrenfors P, Thorell A, Ljungqvist O. Preoperative oral carbohydrate treatment attenuates immediate postoperative insulin resistance. Am J Physiol Endocrinol Metab. 2001 Apr;280(4):E576-83. doi: 10.1152/ajpendo.2001.280.4.E576.
• Gustafsson UO, Nygren J, Thorell A, Soop M, Hellstrom PM, Ljungqvist O, Hagstrom-Toft E. Pre-operative carbohydrate loading may be used in type 2 diabetes patients. Acta Anaesthesiol Scand. 2008 Aug;52(7):946-51. doi: 10.1111/j.1399-6576.2008.01599.x. Epub 2008 Mar 7.
• Lee B, Kim SY, Cho BW, Suh S, Park KK, Choi YS. Preoperative Carbohydrate Drink Intake Increases Glycemic Variability in Patients with Type 2 Diabetes Mellitus in Total Joint Arthroplasty: A Prospective Randomized Trial. World J Surg. 2022 Apr;46(4):791-799. doi: 10.1007/s00268-021-06437-1. Epub 2022 Jan 10.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 20, 2019
• Primary Completion (ACTUAL): October 7, 2020
• Study Completion (ACTUAL): October 15, 2020

Study Registration Dates

• First Submitted: June 26, 2019
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (ACTUAL): July 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 25, 2021
• Last Update Submitted That Met QC Criteria: May 23, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 4-2019-0428

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No