Comparison of two types of carbohydrate loading- carbohydrate rich fluid versus commercially prepared coconut water in terms of peri-operative morbidities in patients undergoing elective, abdominal surgeries - A Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- To compare insulin resistance between two groups- one receiving carbohydrate rich preparation and the other receiving coconut water preparation, using HOMA-IR method (Homeostatic Model Assessment- Insulin Resistance), LAP index (Lipid Accumulation Product index) and TyG index (Triglyceride -Glucose Index) – before and after carbohydrate loading.
研究概览
简要总结
During any surgery, the surgical stress can cause decreased sensitivity of body cells towards insulin, resulting in insulin resistance and subsequent hyperglycemia. This upsets the inflammatory, endocrine and immunological homeostasis of the body and can result in various psychosomatic symptoms like pain, hunger, thirst, fatigue, anxiety etc. in the peri-operative period and in the post-operative period, it can result in prolonged hospital stay, readmission, increased surgical site infections etc. Various studies have shown that this insulin resistance can be significantly reduced by giving a carbohydrate rich drinks to patients, 2 hours prior to surgery, instead of making them fast overnight. In this randomized control trial, we hypothesize that coconut water is not inferior to the carbohydrate drinks that are typically used for carbohydrate loading in surgical patients in order to reduce peri-operative insulin resistance (non-inferiority trial). In this study, we plan to compare the difference between insulin resistance between 2 groups of patients who are posted for elective abdominal surgeries- one receiving carbohydrate rich drink and the other group receiving commercially prepared coconut water, 2 hours prior to surgery. Timed blood samples will be collected to measure serum insulin, blood glucose levels, C-peptide level at baseline (fasting) and 2 hours later after pre-loading them with carbohydrate drink or coconut water (post-prandial sample). Serum triglyceride will also be measured as fasting value. The derivatives of insulin resistance will be calculated as a primary outcome and will be compared using HOMA-IR (homeostatic model assessment for insulin resistance), LAP Index (lipid accumulation product index) and TyG Index (triglyceride glucose index). The psychosomatic status (like hunger, thirst, pain, anxiety, mouth dryness, nausea, headache) will be calculated as secondary outcome using VAS scores (visual analogue scale) at fasting and post-prandial levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria:
- •Age group 18-65 years
- •Patients undergoing elective, minor (level 2), intermediate (level 3) or high risk (level 4) abdominal surgeries involving upper and lower gastrointestinal tracts, hepatic resection or biliary reconstruction.
- •Patients undergoing inguinal, umbilical or incisional hernia repair.
- •All ASA1 and ASA 2 patients undergoing the above-mentioned surgeries who do not meet the exclusion criteria.
排除标准
- •Exclusion criteria:
- •Patients having conditions that impair gastric emptying time – GERD, obesity, pregnancy, gastric outlet obstruction, intestinal obstruction, patients on certain pharmacological agents (like Morphine, tricyclic antidepressants, Levo-dopa) or patients who are unable to tolerate oral diet.
- •Patients having conditions affecting blood sugar level/ insulin level/ patient prone for dyselectrolytaemia – Diabetes Mellitus, Chronic Kidney Disease, Pancreatic tumor, or tumor involving pancreatic resection, adrenal insufficiency, or patients receiving colonic preparation prior to surgery.
- •Conditions that can affect the inflammatory markers- patients with sepsis, emergency procedures, and those undergoing oncological surgeries.
- •Patients undergoing very low risk (level 1) or very high risk (level 5) elective abdominal surgeries.
- •ASA 3, ASA 4 and ASA 5 patients.
- •Conditions that can affect glucose homeostasis- chronic liver disease, hyperthyroidism, HIV-AIDS, patients on steroid therapy.
- •Pregnant and lactating mothers.
- •Patients with BMI less than 18 or more than 30.
结局指标
主要结局
To compare insulin resistance between two groups- one receiving carbohydrate rich preparation and the other receiving coconut water preparation, using HOMA-IR method (Homeostatic Model Assessment- Insulin Resistance), LAP index (Lipid Accumulation Product index) and TyG index (Triglyceride -Glucose Index) – before and after carbohydrate loading.
时间窗: The outcome will be assessed at | - baseline (fasting) and | - 2 hours after pre-loading with the drink (post-prandial). | It will be assessed on the same day, 2 hours apart.
次要结局
- 1. To compare C-Peptide levels before & after carbohydrate loading in two groups- one receiving carbohydrate rich preparation & the other receiving coconut water preparation.(2. To compare the psychosomatic status of the patients before & after receiving carbohydrate loading in the two groups using Visual Analogue Scale (VAS Scale) – anxiety, hunger, thirst, dryness of mouth, fatigue, headache, nausea, pain.)
研究者
Dr Borna Das
Christian Medical College Vellore