Carbohydrate Loading in Type 2 Diabetes Mellitus

Not Applicable

Completed

• Conditions: Diabetes Mellitus Type 2

• Registration Number: NCT06687811
• Lead Sponsor: Indonesia University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-22
• Primary Completion: 2023-12-20
• Study Completion: 2024-01-31
• Status Verified: 2024-11
• Study First Submitted: 2024-11-10
• Study First Submitted QC: 2024-11-12
• Last Update Submitted: 2024-11-12
• Study First Posted: 2024-11-14
• Last Update Posted: 2024-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Perioperative Blood Glucose Level	Preoperative (before intervention), 1 hour intraoperative, 30 minutes postoperative, 1 day postoperative	Blood glucose sampled from vein and capillary, measured in mg/dL
Insulin Resistance	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 Outcome Measures

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

Trial Locations

Locations (1)

RSUPN Cipto Mangunkusumo; 🇮🇩 Central Jakarta, Jakarta, Indonesia