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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04013594
Enrollment
50
Registered
2019-07-09
Start date
2019-08-20
Completion date
2020-10-15
Last updated
2021-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

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.

Interventions

DIETARY_SUPPLEMENTcarbohydrate group

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

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Glycemic variabilityBefore anesthesia\- Coefficient of glucose variability =SD/mean x 100 (%)

Secondary

MeasureTime frameDescription
Insulin resistanceBefore anesthesiaInsulin resistance index = fasting glucose x fasting insulin/22.5
gastric volumeBefore anesthesiagastric volume measured by ultrasonography.
hand grip strengthBefore anesthesiahand grip strength measured by electronic hand dynamometer

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026