Carbohydrate Loading in Type 2 Diabetes Mellitus

University of Indonesia (UI)

Status: Completed

Conditions: Diabetes Mellitus Type 2

Treatments: Other: preoperative carbohydrate loading; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06687811

IndonesiaUAnes093

Details and patient eligibility

About

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

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 2 patient groups, including a placebo group

Carbohydrate loading (CHO) group

Active Comparator group

Description:

Patient received preoperative carbohydrate loading of 200 ml Maltodextrin 12.5%, given 2 hours before the operation

Treatment:

Other: preoperative carbohydrate loading

Control

Placebo Comparator group

Description:

Patient received preoperative regular drinking water of 200 ml with zero-calorie sweetener, given 2 hours before the operation

Treatment:

Other: Placebo