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

NCT04206189 | Completed DMC

• 1 other identifier: 4-2019-1014
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Old Age

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• glycemic variability

  Before anesthesia

• glycemic variability

  5 minutes after anesthesia

• glycemic variability

  1 hour after surgery

• glycemic variability

  10 minutes after admission of recovery room

Study Arms (2)

Carbohydrate group

ACTIVE COMPARATOR

Dietary Supplement: carbohydrate group - carbohydrate (400ml)

Control group

NO INTERVENTION

Interventions

carbohydrate group - carbohydrate (400ml) DIETARY_SUPPLEMENT

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.

Carbohydrate group

Eligibility Criteria

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

You may qualify if:

• Patients undergoing arthroplasty
• age\>65 years

You may not qualify if:

• The subject is a foreigner or illiterate
• Patients with gastroesophageal reflux disease, gastric emptying disorders, inflammatory bowel disease, or previous treatment for intra-abdominal cancer
• Patients with chronic renal disease or severe cardiovascular disease
• HbA1c \>69 mmol/mol or BMI \>30 kg/m2
• A duration of ≥5 h between consumption of CHO and initiation of surgery.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine , Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, South Korea

Location

Related Publications (3)

• 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.

  PMID: 31440156 BACKGROUND

• 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.

  PMID: 28048971 BACKGROUND

• 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.

  PMID: 35576534 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator and outcomes assessor are blinded to group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 15, 2019
• First Posted: December 20, 2019
• Study Start: April 1, 2020
• Primary Completion: January 13, 2021
• Study Completion: January 18, 2021
• Last Updated: May 25, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)