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

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04206189
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.6
• Patients Per Site Per Month: 5.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Old Age	Dietary Supplement: carbohydrate group - carbohydrate (400ml)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.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.
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: Investigator and outcomes assessor are blinded to group assignment.
• Primary Purpose: Prevention
• Official Title: Effect of Preoperative Oral Carbohydrates on the Insulin Resistance of Elderly Patients
• Actual Study Start Date: Apr 1, 2020
• Actual Primary Completion Date: Jan 13, 2021
• Actual Study Completion Date: Jan 18, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.
No Intervention: Control group

Outcome Measures

Primary Outcome Measures

1. Insulin resistance [Before anesthesia]

   Insulin resistance index = glucose x insulin/22.5

2. Insulin resistance [1 hour after surgery]

   Insulin resistance index = glucose x insulin/22.5

Secondary Outcome Measures

1. glycemic variability [Before anesthesia]

   Coefficient of glucose variability =SD/mean x 100 (%)

2. glycemic variability [5 minutes after anesthesia]

   Coefficient of glucose variability =SD/mean x 100 (%)

3. glycemic variability [1 hour after surgery]

   Coefficient of glucose variability =SD/mean x 100 (%)

4. glycemic variability [10 minutes after admission of recovery room]

   Coefficient of glucose variability =SD/mean x 100 (%)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Pain Medicine , Anesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul		Korea, Republic of

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT04206189
• Other Study ID Numbers: 4-2019-1014
• First Posted: Dec 20, 2019
• Last Update Posted: May 25, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Insulin Resistance

Study Results

No Results Posted as of May 25, 2021