Clinical trial NCT06687811: Carbohydrate Loading in Type 2 Diabetes Mellitus
Official title: The Effects of Preoperative Carbohydrate Loading on Perioperative Blood Glucose Levels and Insulin Resistance in Type 2 Diabetes Mellitus Patients Undergoing Elective Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 2
Keywords: Carbohydrate loading
Type 2 Diabetes Mellitus
Perioperative blood glucose
Insulin resistance
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Perioperative Blood Glucose Level
timeFrame: Preoperative (before intervention), 1 hour intraoperative, 30 minutes postoperative, 1 day postoperative
measure: Insulin Resistance
timeFrame: preoperative and 30 minutes postoperative
Secondary outcomes:
measure: Abnormal blood glucose incidence
timeFrame: Preoperative, 1 hour intraoperative, 30 minutes postoperative, 1 day postoperative
measure: Complications
timeFrame: Up to 1 week postoperative or discharged from hospital stay
Other outcomes:
Locations:
city: Central Jakarta
country: Indonesia
facility: RSUPN Cipto Mangunkusumo
state: Jakarta
Study officials:
References:
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