Acute Phase Response, Insulin Resistance
Conditions
Keywords
preoperative fasting, insulin resistance, carbohydrates, whey protein, inflammatory response
Brief summary
Prolonged fasting may increase the organic response to trauma. Carbohydrate-based drinks have been tested and they may reduce insulin resistance. No study so far has aimed to examine the possible benefits of whey protein drink in the composition of preoperative drinks.
Detailed description
The patients will be randomized into two groups: the carbohydrate-protein group (CHO-P) and the control group (CO). The patients will reeive a specific drink to their group on the evening prior to surgery and three hours before the operation. The CHO-P group will receive 474 ml (evening drink) or 237 ml (3h prior to operation drink) of a solution containing 14% whey protein (100% lactoalbumin), 86% carbohydrates (45% hydrolyzed corn starch and 55% sucrose) and 0% lipids (Resource® Breeze - Nestlé, São Paulo, Brasil) and the CO group will receive the same volume of water. Outcome measures On the day of the surgery and on the first postoperative day blood samples will be collected for glucose, insulin, triglycerides, albumin, pre-albumin, CRP, and α-1-acid glycoprotein (α-1-GA) assays. HOMA-IR will be calculated
Interventions
DIETARY_SUPPLEMENTwhey protein plus carbohydrate drink
The CHO-P group received 474 ml (evening drink) or 237 ml (3h prior to operation drink) of a solution containing 14% whey protein (100% lactoalbumin), 86% carbohydrates (45% hydrolyzed corn starch and 55% sucrose) and 0% lipids (Resource® Breeze - Nestlé, São Paulo, Brasil)
Sponsors
Federal University of Mato Grosso
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults (18-65 years-old) * Both sexes * Candidates to elective moderate operations such as open cholecystectomy, laparoscopic cholecystectomy and unilateral repair of inguinal hernia).
Exclusion criteria
* Acute cholecystitis * Diabetes mellitus * Chronic kidney failure * Chronic liver disease ot serum bilirubin greater than 2 mg/dL, body mass index (BMI) above 35Kg/m2 * American Anesthesiologists Association (ASA) score above 2 * Gastro-esophageal reflux * Gastroparesis or intestinal obstruction * Patients with any non-compliance with the study protocol, or who had associated operations, or presented significant intraoperative occurrences, or experienced prolonged operations (lasting more than 3 hours) were also excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| insulin resistance | Homa-IR will be assessed in two time points: baseline (2-3 h before operatio) and 24h after operation | Insulin resistance will be assessed by Homa-IR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| acute-phase response | Assays for the various acute-phase proteins will be done 2-3h before operation and 24 h after the operation | Assays for albumin, pre-albumin, C reactive protein and α-1-acid glycoprotein |
Countries
Brazil
Outcome results
None listed