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Clinical Trials/NCT06687811
NCT06687811
Completed
Not Applicable

The Effects of Preoperative Carbohydrate Loading on Perioperative Blood Glucose Levels and Insulin Resistance in Type 2 Diabetes Mellitus Patients Undergoing Elective Surgery

Indonesia University1 site in 1 country44 target enrollmentJune 22, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus Type 2
Sponsor
Indonesia University
Enrollment
44
Locations
1
Primary Endpoint
Insulin Resistance
Status
Completed
Last Updated
last year

Overview

Brief Summary

The goal of this clinical trial is to learn the effects of preoperative carbohydrate loading on perioperative blood glucose levels and insulin resistance in type 2 diabetes mellitus undergo elective surgery. The main questions it aims to answer are:

  • Does carbohydrate loading affects perioperative blood glucose and insulin resistance in type 2 diabetes mellitus patients undergo surgery?
  • How are the incident of perioperative hyperglycemia and hypoglycemia between subjects who receive placebo compared with subjects who receive carbohydrate loading
  • How are the hyperglycemia-related complications comparison between two groups?

Researchers will compare the carbohydrate loading intervention to placebo (regular drinking water with zero-calorie sweetener) to see the effects of carbohydrate loading to blood glucose levels and insulin resistance (by HOMA-IR value)

Participants will:

  • randomized to carbohydrate loading (CHO) group or placebo
  • checked for preoperative, intraoperative, postoperative blood glucose, and preoperative and postoperative insulin level
  • evaluated for any hyperglycaemia-related complications
Registry
clinicaltrials.gov
Start Date
June 22, 2023
End Date
January 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aries Perdana

Staff of Departement of Anesthesiology and Intensive Care, Division of Cardiac Anesthesia

Indonesia University

Eligibility Criteria

Inclusion Criteria

  • Controlled type 2 diabetes mellitus with any treatment
  • BMI \<30 kg/m2
  • Non-major elective surgery

Exclusion Criteria

  • Subject refusal
  • Geriatric patients with frailty score \>4
  • Subjects with critical illness
  • Subjects received steroid treatment
  • Subjects received total parenteral nutrition
  • Subjects with intestinal obstruction
  • Subjects with impaired liver function

Outcomes

Primary Outcomes

Insulin Resistance

Time Frame: preoperative and 30 minutes postoperative

Calculated using Homeostasis Model Assessment Insulin Resistance (HOMA-IR), obtained from measured fasting insulin (μU/ml) × fasting glucose (mmol/l) / 22.5

Perioperative Blood Glucose Level

Time Frame: Preoperative (before intervention), 1 hour intraoperative, 30 minutes postoperative, 1 day postoperative

Blood glucose sampled from vein and capillary, measured in mg/dL

Secondary Outcomes

  • Abnormal blood glucose incidence(Preoperative, 1 hour intraoperative, 30 minutes postoperative, 1 day postoperative)
  • Complications(Up to 1 week postoperative or discharged from hospital stay)

Study Sites (1)

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