Carbohydrate Loading in Type 2 Diabetes Mellitus

November 12, 2024 updated by: Aries Perdana, Indonesia University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Jakarta
      • Central Jakarta, Jakarta, Indonesia, 10430
        • RSUPN Cipto Mangunkusumo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Carbohydrate loading (CHO) group
Patient received preoperative carbohydrate loading of 200 ml Maltodextrin 12.5%, given 2 hours before the operation
Other: preoperative carbohydrate loading
Patients receive 200 ml drink containing Maltodextrin 12.5%, 2 hours prior to surgery
Other Names:
  • CHO
Placebo Comparator: Control
Patient received preoperative regular drinking water of 200 ml with zero-calorie sweetener, given 2 hours before the operation
Other: Placebo
Patients receive 200 ml regular drinking water with zero-calorie sweetener, 2 hours prior to surgery
Other Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Preoperative (before intervention), 1 hour intraoperative, 30 minutes postoperative, 1 day postoperative
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
preoperative and 30 minutes postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abnormal blood glucose incidence
Time Frame: Preoperative, 1 hour intraoperative, 30 minutes postoperative, 1 day postoperative
Blood glucose level below 60 mg/dL (hypoglycaemia) or above 200 mg/dL (hyperglycaemia)
Preoperative, 1 hour intraoperative, 30 minutes postoperative, 1 day postoperative
Complications
Time Frame: Up to 1 week postoperative or discharged from hospital stay
Hyperglycaemia-related complications, such as surgical site infection, aspiration, prolonged length of hospital stay
Up to 1 week postoperative or discharged from hospital stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2023

Primary Completion (Actual)

December 20, 2023

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

November 10, 2024

First Submitted That Met QC Criteria

November 12, 2024

First Posted (Estimated)

November 14, 2024

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 12, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IndonesiaUAnes093

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification

IPD Sharing Time Frame

Beginning 3 months and ending 5 years following article publication

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal. Proposals should be directed to erika.sasha@ui.ac.id. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years after publication at a third party website (link in process will be updated to be included)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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