Effect of Preoperative Oral Carbohydrates on the Insulin Resistance of Elderly Patients

Postoperative cognitive dysfunction (POCD) is more common in older patients, and increased insulin resistance is an important factor for POCD. Fasting before surgery is performed to reduce the incidence of pulmonary aspiration after anesthesia. However, prolonged fasting increases insulin resistance. Recently, it is recommended to minimize fasting times and consume carbohydrate drinks before surgery. Therefore, the investigators investigate whether preoperative carbohydrate drinks can reduce insulin resistance in the elderly patients. Fifty patients (age>65 years) scheduled for arthroplasty will be divided into carbohydrate (n=28) and control (n=28) 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 h before surgery according to standard protocol.

Study Overview

• Status: Completed
• Conditions: Old Age
• Intervention / Treatment: Dietary supplement: carbohydrate group - carbohydrate (400ml)

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Department of Anesthesiology and Pain Medicine , Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients undergoing arthroplasty
2. age>65 years

Exclusion Criteria:

1. The subject is a foreigner or illiterate
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 h between consumption of CHO and initiation of surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Active Comparator: Carbohydrate group	Dietary supplement: carbohydrate group - carbohydrate (400ml); Randomly selected patients of the carbohydrate group are given oral carbohydrate (400ml) 2-3 hours before surgery. In contrast, patients in the control group are fasted water 2 hours before surgery according to the standard protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin resistance	Insulin resistance index = glucose x insulin/22.5	Before anesthesia
Insulin resistance	Insulin resistance index = glucose x insulin/22.5	1 hour after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
glycemic variability	Coefficient of glucose variability =SD/mean x 100 (%)	Before anesthesia
glycemic variability	Coefficient of glucose variability =SD/mean x 100 (%)	5 minutes after anesthesia
glycemic variability	Coefficient of glucose variability =SD/mean x 100 (%)	1 hour after surgery
glycemic variability	Coefficient of glucose variability =SD/mean x 100 (%)	10 minutes after admission of recovery room

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• He X, Long G, Quan C, Zhang B, Chen J, Ouyang W. Insulin Resistance Predicts Postoperative Cognitive Dysfunction in Elderly Gastrointestinal Patients. Front Aging Neurosci. 2019 Aug 8;11:197. doi: 10.3389/fnagi.2019.00197. eCollection 2019.
• Tang N, Jiang R, Wang X, Wen J, Liu L, Wu J, Zhang C. Insulin resistance plays a potential role in postoperative cognitive dysfunction in patients following cardiac valve surgery. Brain Res. 2017 Feb 15;1657:377-382. doi: 10.1016/j.brainres.2016.12.027. Epub 2016 Dec 31.
• Choi YS, Cho BW, Kim HJ, Lee YS, Park KK, Lee B. Effect of Preoperative Oral Carbohydrates on Insulin Resistance in Older Adults Who Underwent Total Hip or Knee Arthroplasty: A Prospective Randomized Trial. J Am Acad Orthop Surg. 2022 Oct 15;30(20):971-978. doi: 10.5435/JAAOS-D-21-00656. Epub 2022 May 13.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): January 13, 2021
• Study Completion (Actual): January 18, 2021

Study Registration Dates

• First Submitted: December 15, 2019
• First Submitted That Met QC Criteria: December 19, 2019
• First Posted (Actual): December 20, 2019

Study Record Updates

• Last Update Posted (Actual): May 25, 2021
• Last Update Submitted That Met QC Criteria: May 24, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: 4-2019-1014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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