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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT05293444

Recruitment Status : Recruiting

First Posted : March 24, 2022

Last Update Posted : March 28, 2022

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Institute of Liver and Biliary Sciences, India

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Dietary Supplement: Maltodextrine Other: overnight fasting	Not Applicable

Show detailed description

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.

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	70 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Supportive Care
Official Title:	Effect of Preoperative Carbohydrate Loading on Post-operative Insulin Resistance After Donor Hepatectomy: A Randomized Controlled Trial
Actual Study Start Date :	March 24, 2022
Estimated Primary Completion Date :	August 30, 2023
Estimated Study Completion Date :	August 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Organ Donation

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Overnight fasting overnight fasting(minimum 6 hrs) for control group.	Other: overnight fasting no intervention
Experimental: Maltodextrin 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.	Dietary Supplement: Maltodextrine 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.

Outcome Measures

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. [ Time Frame: Post operative day 2 ]

Secondary Outcome Measures :

To compare the functional recovery by total bilirubin on postoperative day 1 [ Time Frame: Post operative day 1 ]
To compare the functional recovery by PT/INR on postoperative day 1 [ Time Frame: Post operative day 1 ]
To compare the functional recovery by total bilirubin on postoperative day 3. [ Time Frame: Post operative day 3 ]
To compare the functional recovery by PT/INR on postoperative day 3. [ Time Frame: Post operative day 3 ]
To compare the functional recovery by total bilirubin on postoperative day 5. [ Time Frame: Post operative day 5 ]
To compare the functional recovery by PT/INR on postoperative day 5. [ Time Frame: Post operative day 5 ]
To compare the functional recovery by total bilirubin on postoperative day 7 [ Time Frame: Post operative day 7 ]
To compare the functional recovery by PT/INR on postoperative day 7 [ Time Frame: Post operative day 7 ]
To compare the functional recovery by total bilirubin on postoperative day 14. [ Time Frame: Post operative day 14. ]
To compare the functional recovery by PT/INR on postoperative day 14. [ Time Frame: Post operative day 14. ]
To compare the IL-6 levels after 48 hours of surgery. [ Time Frame: 48 hours after surgery. ]
To compare the C-reactive protein levels after 48 hours of surgery. [ Time Frame: 48 hours after surgery. ]
To compare the IL-6 levels on day 7 after surgery. [ Time Frame: On day 7 after surgery. ]
To compare the C-reactive protein levels on day 7 after surgery. [ Time Frame: On day 7 after surgery. ]
To compare the incidence of post operative nausea & vomiting till discharge [ Time Frame: 1 week after surgery. ]
To compare the length of hospital stay. [ Time Frame: 2 weeks after surgery ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05293444

Contacts

Layout table for location contacts

Contact: Mahendra Kumar, MS	01146300000	mahendrakhora89@gmail.com

Locations

Layout table for location information

India
Institute of Liver and Biliary Sciences	Recruiting
New Delhi, India, 110070
Contact: Mahendra Kumar, MS 0114600000 mahendrakhora89@gmail.com

Sponsors and Collaborators

Institute of Liver and Biliary Sciences, India

Investigators

Layout table for investigator information

Study Director:	Viniyendra Pamecha, MS, FRCS(UK)	Institute of Liver and Biliary Sciences, New Delhi

More Information

Layout table for additonal information

Responsible Party:	Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier:	NCT05293444
Other Study ID Numbers:	ILBS-Donor Hepatectomy-01
First Posted:	March 24, 2022 Key Record Dates
Last Update Posted:	March 28, 2022
Last Verified:	February 2022

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

Layout table for MeSH terms

Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases

To Top