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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04013594
Recruitment Status : Recruiting
First Posted : July 9, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Diabetes Dietary Supplement: carbohydrate group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Preoperative Oral Carbohydrates on the Glycemic Variability of Diabetic Patients
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
Experimental: carbohydrate group(CHO group) Dietary Supplement: carbohydrate group
Randomly selected patients of the carbohydrate group are given oral carbohydrate (400ml) 2-3 hours before surgery.

No Intervention: control group



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04013594


Contacts
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Contact: Yong Seon Choi, MD., Ph.D 82-2-2228-2412 YSCHOI@yuhs.ac

Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine Recruiting
Seoul, Korea, Republic of, 03722
Contact: Yong Seon Choi, MD, Ph.D    82-2-2228-2412    yschoi@yush.ac   
Sponsors and Collaborators
Yonsei University

Publications:
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT04013594    
Other Study ID Numbers: 4-2019-0428
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No