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Completed

NCT Number: NCT06687811

Carbohydrate Loading in Type 2 Diabetes Mellitus

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

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RSUPN Cipto Mangunkusumo

Central Jakarta, Jakarta Special Capital Region, 10430, Indonesia

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

preoperative carbohydrate loading

Other

Patients receive 200 ml drink containing Maltodextrin 12.5%, 2 hours prior to surgery

Other names: CHO

Placebo

Other

Patients receive 200 ml regular drinking water with zero-calorie sweetener, 2 hours prior to surgery

Other names: Control

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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)

  2. 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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Nov 14, 2024
Registry last updated
Nov 14, 2024

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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