Diabetes Mellitus Type 2
Conditions
Keywords
Carbohydrate loading, Type 2 Diabetes Mellitus, Perioperative blood glucose, Insulin resistance
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
Interventions
Patients receive 200 ml drink containing Maltodextrin 12.5%, 2 hours prior to surgery
OTHERPlacebo
Patients receive 200 ml regular drinking water with zero-calorie sweetener, 2 hours prior to surgery
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Indonesia
Outcome results
None listed