Effect of Preoperative Carbohydrate Loading on Post-operative Insulin Resistance After Donor Hepatectomy.
Condition: Healthy
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      It's a randomized control trial to compare the effect of preoperative carbohydrate loading
      versus fasting on post operative insulin resistance after donor hepatectomy in terms of donor
      outcomes. Investigator will analyze the data and elucidate the value of post operative
      insulin resistance in reducing the occurrence of complications, length of hospital stay and
      fastening the recovery in donors of Live donor liver transplantation.
    

Detailed description: 
      AIM: Investigator aim to study the effect of preoperative carbohydrate loading on insulin
      resistance and functional recovery after donor hepatectomy.

      (B) Methodology: Present study will be a Randomized Control Trial with randomization into
      either study group or control group. Study group will undergo preoperative carbohydrate
      loading while control group will have conventional preoperative fasting (minimum 6 hours) in
      donors undergoing donor hepatectomy in live donor liver transplantation. Patients will be
      allocated to each arm on the basis of block randomization.

      400 ml of clear carbohydrate drink (12.5 g/100 ml maltodextrin,50 kcal/100 ml) at 10 PM night
      before surgery & 200 ml, 2 hr before induction of anaesthesia will be given to the study
      group while overnight fasting(minimum 6 hrs) will be given for control group.

      After donor hepatectomy, Insulin resistance will be calculated by HOMA-IR score at 6 AM on
      Day of Surgery, 6hrs after surgery, 12 hours and 36 hours (POD 2) after surgery. C-reactive
      protein and IL-6 at 6 AM on Day of Surgery, 48 hrs & on day 7 after surgery. Functional
      recovery of remnant liver will be assesed by normalization of total bilirubin and PT/INR till
      discharge and on day 14 after surgery. Peak lactate levels & time taken for normalization of
      lactate will be taken. Incidence of post operative nausea and vomiting and length of hospital
      stay will be compared between the two groups

      Clinical and demographic parameters to be assessed- Donor-preoperative-Age, sex, BMI, LFTs,
      HbA1c, HOMA-IR, IL-6, CRP Operative parameters-duration of surgery, blood loss Postoperative
      serial measurements of the following parameters-

      HOMA-IR, IL-6, CRP, Lactate level, LFTs, PT-INR, Post operative nausea & vomiting, Day of
      discharge These patients would be followed closely in the post-operative period and would be
      serially sampled at pre-defined time points for the aforementioned variables. At the end of
      the study the incidence of complications as well as improvement in postoperative recovery
      will be compared between the 2 groups. The clinical and laboratory parameters will be
      compared between those received preoperative carbohydrate loading and overnight fasting
      group.

      Study Population: Consecutive patients undergoing live donor hepatectomy at ILBS during the
      study period.

      Study Design:-Randomised Controlled Trial Study Period: December 2021 to May 2023. Inclusion
      Criteria All consecutive live liver donors who undergo donor hepatectomy at ILBS Exclusion
      criteria Patients refusing to consent for inclusion in the study. Donor hepatectomy for
      ALF(acute liver failure) recipient

      Sample Size Assuming that HOMA-IR in conventional group is 1.7±0.1 and further investigator
      assume that there will be 25% reduction by preoperative carbohydrate loading with α-5%,
      Power- 90% and 1:1 ratio. Investigator need to enroll 70 cases i.e, 35 in each group. They
      will be randomly allocated in two groups by block randomization method, taking block size as
      10 (5 in interventional & conventional group each).

      Intervention: In Experimental group the preoperative carbohydrate loading will be done.

      The control group will undergo overnight fasting (minimum 6 hrs) preoperatively.

      Monitoring and Assessment:

      Variables to be measured:

      Donor- Preoperative parameters: age, sex, BMI, LFTs, HbA1c, HOMA-IR, IL-6, CRP Operative
      parameters: Duration of surgery, blood loss, Postoperative serial measurements of the
      following from day one to discharge HOMA-IR, Lactate, IL-6, CRP, LFTs, PT-INR, Post operative
      nausea & vomiting,

      Day of discharge.

      Timing of Sample Collection Group A Preoperative Baseline ( at 6 AM on day of surgery.
      Post-Operative:-6 hours after surgery & then daily till discharge. Group B Preoperative
      Baseline ( at 6 AM on day of surgery. Post-Operative:-6 hours after surgery & then daily till
      discharge. Adverse Effects: None

      Statistical Analysis:

      Data will be entered in excel worksheet and Statistical analyses will be performed with SPSS
      Statistics version 22 (IBM Corp., Armonk, NY). Statistical data will be represented as
      frequencies (%) where the continuous variables will be expressed as medians and interquartile
      range (IQRs). Continuous variables will be compared with the student t test and Mann-Whitney
      test as appropriate. Differences between proportions derived from categorical data will be
      compared with Chi-square or Fisher's exact test. Variables will be correlated with clinical
      outcomes. Repeated analysis of measures will be applied wherever applicable.

      Stopping Rule- In case of significant adverse effects in the experimental arm. (c) EXPECTED
      OUTCOME:

        1. To establish that preoperative carbohydrate loading will decrease the post operative
           insulin resistance and enhances functional recovery after donor hepatectomy.

        2. To establish that preoperative carbohydrate loading reduces inflammatory stress
           response, incidence of post operative nausea & vomiting and improves the surgical
           clinical outcomes.
    

Intervention name(s): Maltodextrine; overnight fasting
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 400 ml at 10PM night before surgery(12.5g/100ml) 200 ml in the morning at 6 AM (12.5g/100ml) on the day of surgery.; no intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care