Clinical trial NCT04013594: Effect of Preoperative Oral Carbohydrates on the Glycemic Variability of Diabetic Patients
Official title: Effect of Preoperative Oral Carbohydrates on the Glycemic Variability of Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Glycemic variability
timeFrame: Before anesthesia
measure: Glycemic variability
timeFrame: Before anesthesia
measure: Glycemic variability
timeFrame: immediately after anesthesia
measure: Glycemic variability
timeFrame: immediately after anesthesia
measure: Glycemic variability
timeFrame: operation end
measure: Glycemic variability
timeFrame: operation end
measure: Glycemic variability
timeFrame: 1 hour after surgery
measure: Glycemic variability
timeFrame: 1 hour after surgery
Secondary outcomes:
measure: Insulin resistance
timeFrame: Before anesthesia
measure: Insulin resistance
timeFrame: Before anesthesia
measure: Insulin resistance
timeFrame: Before anesthesia
measure: Insulin resistance
timeFrame: Before anesthesia
measure: Insulin resistance
timeFrame: Before anesthesia
measure: gastric volume
timeFrame: Before anesthesia
measure: hand grip strength
timeFrame: Before anesthesia
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Study officials:
References:
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. doi: 10.1152/ajpendo.2001.280.4.E576.
citation: Gustafsson UO, Nygren J, Thorell A, Soop M, Hellstrom PM, Ljungqvist O, Hagstrom-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.
citation: Lee B, Kim SY, Cho BW, Suh S, Park KK, Choi YS. Preoperative Carbohydrate Drink Intake Increases Glycemic Variability in Patients with Type 2 Diabetes Mellitus in Total Joint Arthroplasty: A Prospective Randomized Trial. World J Surg. 2022 Apr;46(4):791-799. doi: 10.1007/s00268-021-06437-1. Epub 2022 Jan 10.