Carbohydrate Loading in Type 2 Diabetes Mellitus

Indonesia University44 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Diabetes Mellitus Type 2

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Perioperative Blood Glucose Level

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

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

Insulin Resistance

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

Time frame: preoperative and 30 minutes postoperative

Secondary Outcomes

Abnormal blood glucose incidence

Blood glucose level below 60 mg/dL (hypoglycaemia) or above 200 mg/dL (hyperglycaemia)

Time frame: Preoperative, 1 hour intraoperative, 30 minutes postoperative, 1 day postoperative

Complications

Hyperglycaemia-related complications, such as surgical site infection, aspiration, prolonged length of hospital stay

Time frame: Up to 1 week postoperative or discharged from hospital stay