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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04013594
• Other study ID #: 4-2019-0428
• Status: Completed
• Phase: N/A
• Start date: August 20, 2019
• Est. completion date: October 15, 2020

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 15, 2020
• Est. primary completion date: October 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Intervention

Dietary Supplement:
• carbohydrate group
Randomly selected patients of the carbohydrate group are given oral carbohydrate (400ml) 2-3 hours before surgery.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Gustafsson UO, Nygren J, Thorell A, Soop M, Hellström PM, Ljungqvist O, Hagström-Toft E. Pre-operative carbohydrate loading may be used in type 2 diabetes patients. Acta Anaesthesiol Scand. 2008 Aug;52(7):946-51. doi: 10.1111/j.1399-6576.2008.01599.x. Epub 2008 Mar 7. — View Citation

Soop M, Nygren J, Myrenfors P, Thorell A, Ljungqvist O. Preoperative oral carbohydrate treatment attenuates immediate postoperative insulin resistance. Am J Physiol Endocrinol Metab. 2001 Apr;280(4):E576-83. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic variability	- Coefficient of glucose variability =SD/mean x 100 (%)	Before anesthesia
Primary	Glycemic variability	- J index=0.001 x (MBG +SD)2 mg/dL	Before anesthesia
Primary	Glycemic variability	- Coefficient of glucose variability =SD/mean x 100 (%)	immediately after anesthesia
Primary	Glycemic variability	- J index=0.001 x (MBG +SD)2 mg/dL	immediately after anesthesia
Primary	Glycemic variability	- Coefficient of glucose variability =SD/mean x 100 (%)	operation end
Primary	Glycemic variability	- J index=0.001 x (MBG +SD)2 mg/dL	operation end
Primary	Glycemic variability	- Coefficient of glucose variability =SD/mean x 100 (%)	1 hour after surgery
Primary	Glycemic variability	- J index=0.001 x (MBG +SD)2 mg/dL	1 hour after surgery
Secondary	Insulin resistance	Insulin resistance index = fasting glucose x fasting insulin/22.5	Before anesthesia
Secondary	Insulin resistance	serum laboratory test: glucagon	Before anesthesia
Secondary	Insulin resistance	serum laboratory test: GLP-1	Before anesthesia
Secondary	Insulin resistance	serum laboratory test: C-peptide	Before anesthesia
Secondary	Insulin resistance	serum laboratory test: free fatty acid	Before anesthesia
Secondary	gastric volume	gastric volume measured by ultrasonography.	Before anesthesia
Secondary	hand grip strength	hand grip strength measured by electronic hand dynamometer	Before anesthesia