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

Old Age Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04206189
• Other study ID #: 4-2019-1014
• Status: Completed
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: January 18, 2021

Study information

• Verified date: May 2021
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 18, 2021
• Est. primary completion date: January 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Insulin Resistance
• Old Age

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine , Anesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin resistance	Insulin resistance index = glucose x insulin/22.5	Before anesthesia
Primary	Insulin resistance	Insulin resistance index = glucose x insulin/22.5	1 hour after surgery
Secondary	glycemic variability	Coefficient of glucose variability =SD/mean x 100 (%)	Before anesthesia
Secondary	glycemic variability	Coefficient of glucose variability =SD/mean x 100 (%)	5 minutes after anesthesia
Secondary	glycemic variability	Coefficient of glucose variability =SD/mean x 100 (%)	1 hour after surgery
Secondary	glycemic variability	Coefficient of glucose variability =SD/mean x 100 (%)	10 minutes after admission of recovery room