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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes

Intervention / Treatment
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* Dietary Supplement: carbohydrate group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: carbohydrate group(CHO group)<br> | Dietary Supplement: carbohydrate group<br>* Randomly selected patients of the carbohydrate group are given oral carbohydrate (400ml) 2-3 hours before surgery.<br>|
| No Intervention: control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic variability | - Coefficient of glucose variability =SD/mean x 100 (%) | Before anesthesia | 
| Glycemic variability | - J index=0.001 x (MBG +SD)2 mg/dL | Before anesthesia | 
| Glycemic variability | - Coefficient of glucose variability =SD/mean x 100 (%) | immediately after anesthesia | 
| Glycemic variability | - J index=0.001 x (MBG +SD)2 mg/dL | immediately after anesthesia | 
| Glycemic variability | - Coefficient of glucose variability =SD/mean x 100 (%) | operation end | 
| Glycemic variability | - J index=0.001 x (MBG +SD)2 mg/dL | operation end | 
| Glycemic variability | - Coefficient of glucose variability =SD/mean x 100 (%) | 1 hour after surgery | 
| Glycemic variability | - J index=0.001 x (MBG +SD)2 mg/dL | 1 hour after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin resistance | Insulin resistance index = fasting glucose x fasting insulin/22.5 | Before anesthesia | 
| Insulin resistance | serum laboratory test: glucagon | Before anesthesia | 
| Insulin resistance | serum laboratory test: GLP-1 | Before anesthesia | 
| Insulin resistance | serum laboratory test: C-peptide | Before anesthesia | 
| Insulin resistance | serum laboratory test: free fatty acid | Before anesthesia | 
| gastric volume | gastric volume measured by ultrasonography. | Before anesthesia | 
| hand grip strength | hand grip strength measured by electronic hand dynamometer | Before anesthesia |