Effect of Preoperative Oral Carbohydrates on the Glycemic Variability of Diabetic Patients

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Dietary Supplement: carbohydrate group

• Registration Number: NCT04013594
• Lead Sponsor: Yonsei University

Brief Summary

Preoperative carbohydrate drink intake attenuate insulin resistance. However, carbohydrate loading may compromise blood glucose control in patients with diabetes. There is some evidence that oral carbohydrate loading may be safe in patients with type 2 diabetes. Therefore, the investigators aim to evaluate whether preoperative carbohydrate intake affects insulin resistance and glycemic variability in patients with diabetes. Fifty patients scheduled for total knee arthroplasty will be divided into carbohydrate (n=25) and control (n=25) 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 hours before surgery according to standard protocol.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-26
• Study First Submitted QC: 2019-07-03
• Study First Posted: 2019-07-09
• Study Start: 2019-08-20
• Primary Completion: 2020-10-07
• Study Completion: 2020-10-15
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-23
• Last Update Posted: 2021-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 1. Patients undergoing total knee arthroplasty

Exclusion Criteria

• 1. Patients with contraindications to spinal anesthesia (local infection, clotting disorders, anatomical abnormalities, sepsis, etc.)
• 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 hours between consumption of CHO and initiation of surgery.
• 6. The subject is a foreigner or illiterate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
carbohydrate group(CHO group)	carbohydrate group	-

Primary Outcome Measures

Name	Time	Method
Glycemic variability	1 hour after surgery	- J index=0.001 x (MBG +SD)2 mg/dL

Secondary Outcome Measures

Name	Time	Method
Insulin resistance	Before anesthesia	serum laboratory test: free fatty acid
gastric volume	Before anesthesia	gastric volume measured by ultrasonography.
hand grip strength	Before anesthesia	hand grip strength measured by electronic hand dynamometer

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine; 🇰🇷 Seoul, Korea, Republic of