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NCT Number: NCT04013594

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carbohydrate group

Dietary Supplement

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

Primary outcomes

  1. Glycemic variability

    Time frame: Before anesthesia

    • Coefficient of glucose variability =SD/mean x 100 (%)

  2. Glycemic variability

    Time frame: Before anesthesia

    • J index=0.001 x (MBG +SD)2 mg/dL

  3. Glycemic variability

    Time frame: immediately after anesthesia

    • Coefficient of glucose variability =SD/mean x 100 (%)

  4. Glycemic variability

    Time frame: immediately after anesthesia

    • J index=0.001 x (MBG +SD)2 mg/dL

  5. Glycemic variability

    Time frame: operation end

    • Coefficient of glucose variability =SD/mean x 100 (%)

  6. Glycemic variability

    Time frame: operation end

    • J index=0.001 x (MBG +SD)2 mg/dL

  7. Glycemic variability

    Time frame: 1 hour after surgery

    • Coefficient of glucose variability =SD/mean x 100 (%)

  8. Glycemic variability

    Time frame: 1 hour after surgery

    • J index=0.001 x (MBG +SD)2 mg/dL

Secondary outcomes

  1. Insulin resistance

    Time frame: Before anesthesia

    Insulin resistance index = fasting glucose x fasting insulin/22.5

  2. Insulin resistance

    Time frame: Before anesthesia

    serum laboratory test: glucagon

  3. Insulin resistance

    Time frame: Before anesthesia

    serum laboratory test: GLP-1

  4. Insulin resistance

    Time frame: Before anesthesia

    serum laboratory test: C-peptide

  5. Insulin resistance

    Time frame: Before anesthesia

    serum laboratory test: free fatty acid

  6. gastric volume

    Time frame: Before anesthesia

    gastric volume measured by ultrasonography.

  7. hand grip strength

    Time frame: Before anesthesia

    hand grip strength measured by electronic hand dynamometer

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 9, 2019
Registry last updated
May 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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