Insulin Resistance Clinical Trial
Official title:
A Randomized Controlled Study of Preoperative Oral Carbohydrate Loading Versus Fasting in Patients Undergoing Colorectal Surgery
NCT number | NCT03793036 |
Other study ID # | NR01/19 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2018 |
Est. completion date | December 31, 2018 |
Verified date | January 2019 |
Source | Cantonal Hospital Zenica |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study compared traditional concept of preoperative fasting before elective open colon surgery and preoperative treatment with carbohydrate oral drink in intention to improve postoperative stress response to surgical procedure. Hypothesis was: preoperative oral carbohydrate drink reduces postoperative insulin resistance, improves insulin sensitivity, reduces postoperative inflammatory response in terms of the value of Glasgow Prognostic Score (GPS) and IL-6, improves postoperative patient's subjective well-being and surgical clinical outcome.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - participants with ASA physical status class I-II - aged between 18 years and 70 years - participants scheduled for elective open colon surgery Exclusion Criteria: - previous treatment of colon or any other cancer - disseminated malignant disease - gastro-oesophageal reflux or increased risk of aspiration - body mass index below 20 and above 30 kg/m2 - overall score =3 after final assessment of the nutritional status according to Nutritional Risk Screening 2002 (NRS-2002) - emergency colon surgery - diabetes mellitus - inflammatory bowel disease - immunological therapy - cardiopulmonary disease - neuromusular disease - renal disease - hepatic or endocrine disease - pregnancy - mental disease - allergy to any study drugs - alcoholic or drug abuse - patient's refusal to participate in the study. |
Country | Name | City | State |
---|---|---|---|
Bosnia and Herzegovina | Cantonal Hospital Zenica | Zenica |
Lead Sponsor | Collaborator |
---|---|
Nermina Rizvanovic |
Bosnia and Herzegovina,
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* Note: There are 29 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The mean change in insulin resistance using computer model Homeostasis model assessment of insulin resistance | Blood samples were collected to measure serum levels of glucose and serum levels of insulin. Insulin resistance, was calculated according to the equation = [fasting insulin (µU/ml) x fasting glucose (mmol/L)] / 22,5 using computer model Homeostasis model assessment of insulin resistance 2 Calculator version 2,2. The value >1 indicated the presence of resistance to insulin. | blood samples were taken at 06:00 am on the day of surgery ( basal value), 6 hours post-surgery, at 06.00 am on the first postoperative day and at 06:00 am on the second postoperative day. | |
Primary | The mean change in Glasgow Prognostic Score (GPS). The GPS was obtained as ratio of serum C-reactive protein/albumin. | The GPS was calculated as follow: participants with elevated level of C-reactive protein >10mg/L and albumin <35 g/L were allocated a score of 2. Participants showing one or neither of these blood chemistry abnormalities were allocated a score 1 or 0. | blood samples were taken at four time points: at 06:00 am on the day of surgery ( basal value), 6 hours post-surgery, at 06.00 am on the first postoperative day and at 06:00 am on the second postoperative day. | |
Primary | The mean change in serum level of IL-6 | The concentration of IL-6 in serum has a r.n. 0-5,9 pg/mL. | blood samples were taken at four time points: at 06:00 am on the day of surgery ( basal value), 6 hours post-surgery, at 06.00 am on the first postoperative day and at 06:00 am on the second postoperative day. | |
Secondary | The mean change from baseline in participant's subjective well-being score on Visual Analogue Scale | The participant's subjective well-being included: pain at rest and with movement, thirst, hunger, dry mouth, weakness, anxiety, nausea and vomiting. The mean change were measured using a 10 cm horizontal Visual Analogue Scale. The scales were undivided and limited at both ends by vertical lines. The left end represented "no symptom" (score:0) and the right end represented "the worst imaginable" (score 100) limits of the variable to be evaluated. The participants rated discomfort by marking on the scales line at the point that represented their level of perceived symptom. The distance on the scales line from score 0 to the patient's mark determined the score of symptom intensity. The score was calculated as follow: 0-1cm no symptom; 1-3 cm mild symptom; 3-7 cm moderate symptom; 7-10 cm strong symptom. The patients were questioned about presence of nausea and vomiting at five study time points. A "NO" answer was grade as 1 and a "YES" answer was graded as 2. | The assessment of subjective well-being and pain score was performed immediately before induction into anesthesia and then repeated for 0-4, 4-8, 8-12 and 12-24 hours post-surgery | |
Secondary | surgical clinical outcomes | Surgical clinical outcomes included postoperative return of gastrointestinal function, time to independent ambulation and postoperative discharge day. The return of gastrointestinal function was assessed as follow: the sounds of the bowel were detected by an abdominal auscultation 24, 36, 48, 60, 72 and 80 hours after surgery. The time of the first postoperative flatus and defecation were recorded as well as the time to postoperative oral intake. | from 24 hours post-surgey from apprroximately 10 days post-surgery |
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