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Effect of Preoperative Carbohydrate Loading on Post-operative Insulin Resistance After Donor Hepatectomy.

Primary Purpose

Healthy

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Maltodextrine
overnight fasting
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Healthy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All consecutive live liver donors who undergo donor hepatectomy at ILBS

Exclusion Criteria:

  1. Patients refusing to consent for inclusion in the study.
  2. Donor hepatectomy for ALF(acute liver failure) recipient

Sites / Locations

  • Institute of Liver and Biliary SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Overnight fasting

Maltodextrin

Arm Description

overnight fasting(minimum 6 hrs) for control group.

Route: Oral Dose: 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.

Outcomes

Primary Outcome Measures

To compare the insulin resistance by HOMA-IR(Homeostatic model assessment for insulin resistance) on postoperative day 2 between preoperative carbohydrate loading and conventional fasting group after donor hepatectomy.

Secondary Outcome Measures

To compare the functional recovery by total bilirubin on postoperative day 1
To compare the functional recovery by PT/INR on postoperative day 1
To compare the functional recovery by total bilirubin on postoperative day 3.
To compare the functional recovery by PT/INR on postoperative day 3.
To compare the functional recovery by total bilirubin on postoperative day 5.
To compare the functional recovery by PT/INR on postoperative day 5.
To compare the functional recovery by total bilirubin on postoperative day 7
To compare the functional recovery by PT/INR on postoperative day 7
To compare the functional recovery by total bilirubin on postoperative day 14.
To compare the functional recovery by PT/INR on postoperative day 14.
To compare the IL-6 levels after 48 hours of surgery.
To compare the C-reactive protein levels after 48 hours of surgery.
To compare the IL-6 levels on day 7 after surgery.
To compare the C-reactive protein levels on day 7 after surgery.
To compare the incidence of post operative nausea & vomiting till discharge
To compare the length of hospital stay.

Full Information

First Posted
February 25, 2022
Last Updated
October 5, 2023
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT05293444
Brief Title
Effect of Preoperative Carbohydrate Loading on Post-operative Insulin Resistance After Donor Hepatectomy.
Official Title
Effect of Preoperative Carbohydrate Loading on Post-operative Insulin Resistance After Donor Hepatectomy: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 24, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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: To establish that preoperative carbohydrate loading will decrease the post operative insulin resistance and enhances functional recovery after donor hepatectomy. To establish that preoperative carbohydrate loading reduces inflammatory stress response, incidence of post operative nausea & vomiting and improves the surgical clinical outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Overnight fasting
Arm Type
Other
Arm Description
overnight fasting(minimum 6 hrs) for control group.
Arm Title
Maltodextrin
Arm Type
Experimental
Arm Description
Route: Oral Dose: 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrine
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
overnight fasting
Intervention Description
no intervention
Primary Outcome Measure Information:
Title
To compare the insulin resistance by HOMA-IR(Homeostatic model assessment for insulin resistance) on postoperative day 2 between preoperative carbohydrate loading and conventional fasting group after donor hepatectomy.
Time Frame
Post operative day 2
Secondary Outcome Measure Information:
Title
To compare the functional recovery by total bilirubin on postoperative day 1
Time Frame
Post operative day 1
Title
To compare the functional recovery by PT/INR on postoperative day 1
Time Frame
Post operative day 1
Title
To compare the functional recovery by total bilirubin on postoperative day 3.
Time Frame
Post operative day 3
Title
To compare the functional recovery by PT/INR on postoperative day 3.
Time Frame
Post operative day 3
Title
To compare the functional recovery by total bilirubin on postoperative day 5.
Time Frame
Post operative day 5
Title
To compare the functional recovery by PT/INR on postoperative day 5.
Time Frame
Post operative day 5
Title
To compare the functional recovery by total bilirubin on postoperative day 7
Time Frame
Post operative day 7
Title
To compare the functional recovery by PT/INR on postoperative day 7
Time Frame
Post operative day 7
Title
To compare the functional recovery by total bilirubin on postoperative day 14.
Time Frame
Post operative day 14.
Title
To compare the functional recovery by PT/INR on postoperative day 14.
Time Frame
Post operative day 14.
Title
To compare the IL-6 levels after 48 hours of surgery.
Time Frame
48 hours after surgery.
Title
To compare the C-reactive protein levels after 48 hours of surgery.
Time Frame
48 hours after surgery.
Title
To compare the IL-6 levels on day 7 after surgery.
Time Frame
On day 7 after surgery.
Title
To compare the C-reactive protein levels on day 7 after surgery.
Time Frame
On day 7 after surgery.
Title
To compare the incidence of post operative nausea & vomiting till discharge
Time Frame
1 week after surgery.
Title
To compare the length of hospital stay.
Time Frame
2 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahendra Kumar, MS
Phone
01146300000
Email
mahendrakhora89@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Viniyendra Pamecha, MS, FRCS(UK)
Organizational Affiliation
Institute of Liver and Biliary Sciences, New Delhi
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
ZIP/Postal Code
110070
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahendra Kumar, MS
Phone
0114600000
Email
mahendrakhora89@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Effect of Preoperative Carbohydrate Loading on Post-operative Insulin Resistance After Donor Hepatectomy.

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