NCT04013594

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

August 20, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2020

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2020

Completed
Last Updated

May 25, 2021

Status Verified

May 1, 2021

Enrollment Period

1.1 years

First QC Date

June 26, 2019

Last Update Submit

May 23, 2021

Conditions

Diabetes

Outcome Measures

Primary Outcomes (8)

  • Glycemic variability

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

    Before anesthesia

  • Glycemic variability

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

    Before anesthesia

  • Glycemic variability

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

    immediately after anesthesia

  • Glycemic variability

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

    immediately after anesthesia

  • Glycemic variability

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

    operation end

  • Glycemic variability

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

    operation end

  • Glycemic variability

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

    1 hour after surgery

  • Glycemic variability

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

    1 hour after surgery

Secondary Outcomes (7)

  • Insulin resistance

    Before anesthesia

  • Insulin resistance

    Before anesthesia

  • Insulin resistance

    Before anesthesia

  • Insulin resistance

    Before anesthesia

  • Insulin resistance

    Before anesthesia

  • +2 more secondary outcomes

Study Arms (2)

carbohydrate group(CHO group)

EXPERIMENTAL
Dietary Supplement: carbohydrate group

control group

NO INTERVENTION

Interventions

carbohydrate groupDIETARY_SUPPLEMENT

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

carbohydrate group(CHO group)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Patients undergoing total knee arthroplasty

You may not qualify if:

  • \. Patients with contraindications to spinal anesthesia (local infection, clotting disorders, anatomical abnormalities, sepsis, etc.)
  • \. Patients with gastroesophageal reflux disease, gastric emptying disorders, inflammatory bowel disease, or previous treatment for intra-abdominal cancer
  • \. Patients with chronic renal disease or severe cardiovascular disease
  • \. HbA1c \>69 mmol/mol or BMI \>30 kg/m2
  • \. A duration of ≥5 hours between consumption of CHO and initiation of surgery.
  • \. The subject is a foreigner or illiterate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, 03722, South Korea

Location

Related Publications (3)

  • 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.

    PMID: 11254464BACKGROUND

  • 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.

    PMID: 18331374BACKGROUND

  • 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.

    PMID: 35006328DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2019

First Posted

July 9, 2019

Study Start

August 20, 2019

Primary Completion

October 7, 2020

Study Completion

October 15, 2020

Last Updated

May 25, 2021

Record last verified: 2021-05

Locations

KR(1)