Insulin Resistance Clinical Trial
Official title:
A Randomized Controlled Study of Preoperative Oral Carbohydrate Loading Versus Fasting in Patients Undergoing Colorectal Surgery
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.
This prospective randomized, controlled clinical study was carried out in the Department of
Anesthesiology and Intensive Care Unit and Department of Surgery at the Cantonal Hospital
Zenica, Bosnia and Herzegovina. After obtaining ethical committee approval 50 participants,
scheduled for elective open colon surgery were included into study. Sample size was estimated
using sample size calculator software and power analysis with 95% confidence interval and
power of 80%. Statistical significance was considered as p< 0,05. The calculation indicated
19 participants per group would be sufficient to detect a 50% difference for insulin
resistance between the groups. Assuming dropout would lead to a total sample size of 50
participants. Before each participant agreed to the join the study, the purpose and
procedures of the study were fully explained and informed and written consent was obtained
from each participant. A preoperative anesthetic examination was conducted the day before
surgery. The participants who fulfilled study criteria were randomly allocated into two
groups of 25 participants, depending on the preoperative treatment. The intervention group,
received preoperative carbohydrate oral supplementation (CHO group) and the control group
(FAST group) underwent to a conventional routine of preoperative fasting. Randomization was
performed by computer generated randomization codes. The codes which indicated the treatment
were held in sealed opaque envelopes. Nurse who conducted randomization and opened the
envelopes the night before surgery was blinded to the study protocol as well as the surgeons,
nurses, anesthesiologists and staff involved in data collection.
The participants of FAST group were undergone to the traditional concept of preoperative
fasting before surgical procedure. The participants in the intervention group received
carbohydrate oral supplement at 10:00 pm the evening before surgery and again on the day of
surgery, 2 hours before induction of anesthesia. Assessment of clinical parameters started at
06:00 am on the day of surgery (basal value). The fasting peripheral venous blood samples
were collected to measure serum levels of glucose, insulin, C-reactive protein, albumin and
IL-6, and further 6 hours post-surgery, at 06.00 am on the first postoperative day and at
06:00 am on the second postoperative day. All patients underwent general anesthesia followed
by colon surgery. Assessment of subjective well-being was performed immediately before
induction into anesthesia using a 10 cm horizontal Visual Analogue Scales and then repeated
for 0-4, 4-8, 8-12 and 12-24 hours post-surgery. Pain at rest, pain with mobilization,
thirst, hunger, mouth dryness, anxiety and weakness were evaluated. The patients were
explained how to use the scale. Surgical outcome was evaluated by postoperative return of
gastrointestinal function, time to independent ambulation and postoperative discharge day.
Postoperative data included and the time to oral intake. The following data were recorded
also: age, sex, body weight, body mass index, American Society of Anesthesiologists (ASA)
physical status class, nutritional status of the participants according to Nutritional Risk
Screening 2002 (NRS-2002), tumor localization, type of surgery, duration of surgery,
preoperative fasting time and, blood loss during surgery
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03142633 -
MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome
|
||
Recruiting |
NCT04984226 -
Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD
|
Phase 2 | |
Recruiting |
NCT05354245 -
Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL)
|
N/A | |
Completed |
NCT03383822 -
Regulation of Endogenous Glucose Production by Brain Insulin Action in Insulin Resistance
|
Phase 1/Phase 2 | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Suspended |
NCT03652987 -
Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
|
||
Completed |
NCT04203238 -
Potato Research for Enhancing Metabolic Outcomes
|
N/A | |
Recruiting |
NCT03658564 -
Preoperative Oral Carbohydrate Treatment Minimizes Insulin Resistance
|
N/A | |
Completed |
NCT04183257 -
Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics
|
Phase 4 | |
Completed |
NCT04117802 -
Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome
|
N/A | |
Completed |
NCT03627104 -
Effect of Dietary Protein and Energy Restriction in the Improvement of Insulin Resistance in Subjects With Obesity
|
N/A | |
Completed |
NCT05124847 -
TREating Pediatric Obesity
|
N/A | |
Active, not recruiting |
NCT03288025 -
Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE)
|
N/A | |
Completed |
NCT03809182 -
Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.
|
Phase 4 | |
Completed |
NCT01809288 -
Identifying Risk for Diabetes and Heart Disease in Women
|
||
Completed |
NCT04642482 -
Synbiotic Therapy on Intestinal Microbiota and Insulin Resistance in Obesity
|
Phase 4 | |
Terminated |
NCT03278236 -
Does Time Restricted Feeding Improve Glycaemic Control in Overweight Men?
|
N/A | |
Not yet recruiting |
NCT06159543 -
The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes
|
N/A | |
Not yet recruiting |
NCT05540249 -
Pre-operative Carbohydrates in Diabetic Patients Undergoing CABG
|
N/A | |
Withdrawn |
NCT04741204 -
Metformin Use to Reduce Disparities in Newly Diagnosed Breast Cancer
|
Phase 4 |