Back to resultsEffect of Preoperative Oral Carbohydrates on the Insulin Resistance of Elderly Patients
Primary Purpose
Old Age
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
carbohydrate group - carbohydrate (400ml)
Sponsored by
About this trial
This is an interventional prevention trial for Old Age
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing arthroplasty
- age>65 years
Exclusion Criteria:
- 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.
Sites / Locations
- Department of Anesthesiology and Pain Medicine , Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Carbohydrate group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Insulin resistance
Insulin resistance index = glucose x insulin/22.5
Insulin resistance
Insulin resistance index = glucose x insulin/22.5
Secondary Outcome Measures
glycemic variability
Coefficient of glucose variability =SD/mean x 100 (%)
glycemic variability
Coefficient of glucose variability =SD/mean x 100 (%)
glycemic variability
Coefficient of glucose variability =SD/mean x 100 (%)
glycemic variability
Coefficient of glucose variability =SD/mean x 100 (%)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04206189
Brief Title
Effect of Preoperative Oral Carbohydrates on the Insulin Resistance of Elderly Patients
Official Title
Effect of Preoperative Oral Carbohydrates on the Insulin Resistance of Elderly Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
January 13, 2021 (Actual)
Study Completion Date
January 18, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Old Age
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
InvestigatorOutcomes Assessor
Masking Description
Investigator and outcomes assessor are blinded to group assignment.
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Carbohydrate group
Arm Type
Active Comparator
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
carbohydrate group - carbohydrate (400ml)
Intervention 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 according to the standard protocol.
Primary Outcome Measure Information:
Title
Insulin resistance
Description
Insulin resistance index = glucose x insulin/22.5
Time Frame
Before anesthesia
Title
Insulin resistance
Description
Insulin resistance index = glucose x insulin/22.5
Time Frame
1 hour after surgery
Secondary Outcome Measure Information:
Title
glycemic variability
Description
Coefficient of glucose variability =SD/mean x 100 (%)
Time Frame
Before anesthesia
Title
glycemic variability
Description
Coefficient of glucose variability =SD/mean x 100 (%)
Time Frame
5 minutes after anesthesia
Title
glycemic variability
Description
Coefficient of glucose variability =SD/mean x 100 (%)
Time Frame
1 hour after surgery
Title
glycemic variability
Description
Coefficient of glucose variability =SD/mean x 100 (%)
Time Frame
10 minutes after admission of recovery room
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing arthroplasty
age>65 years
Exclusion Criteria:
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.
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine , Anesthesia and Pain Research Institute, Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31440156
Citation
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.
Results Reference
background
PubMed Identifier
28048971
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.
Results Reference
background
PubMed Identifier
35576534
Citation
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.
Results Reference
derived
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Effect of Preoperative Oral Carbohydrates on the Insulin Resistance of Elderly Patients
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