Effect of Preoperative Carbohydrate Loading on Post-operative Insulin Resistance After Donor Hepatectomy.
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy
Started Feb 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2022
CompletedFirst Submitted
Initial submission to the registry
February 25, 2022
CompletedFirst Posted
Study publicly available on registry
March 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedDecember 5, 2023
October 1, 2023
10 months
February 25, 2022
December 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Post operative day 2
Secondary Outcomes (16)
To compare the functional recovery by total bilirubin on postoperative day 1
Post operative day 1
To compare the functional recovery by PT/INR on postoperative day 1
Post operative day 1
To compare the functional recovery by total bilirubin on postoperative day 3.
Post operative day 3
To compare the functional recovery by PT/INR on postoperative day 3.
Post operative day 3
To compare the functional recovery by total bilirubin on postoperative day 5.
Post operative day 5
- +11 more secondary outcomes
Study Arms (2)
Overnight fasting
OTHERovernight fasting(minimum 6 hrs) for control group.
Maltodextrin
EXPERIMENTALRoute: 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- All consecutive live liver donors who undergo donor hepatectomy at ILBS
You may not qualify if:
- Donor hepatectomy for ALF(acute liver failure) recipient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Liver and Biliary Sciences
New Delhi, 110070, India
Related Publications (1)
Kumar M, Patil NS, Mohapatra N, Yadav A, Sindwani G, Dhingra U, Thomas S, Pamecha V. Preoperative carbohydrate loading reduces perioperative insulin resistance and hastens functional recovery of remnant liver after living donor hepatectomy: An open-label randomized controlled trial. Hepatol Int. 2025 Oct;19(5):1151-1161. doi: 10.1007/s12072-025-10831-5. Epub 2025 May 19.
PMID: 40389625DERIVED
Study Officials
- STUDY DIRECTOR
Viniyendra Pamecha, MS, FRCS(UK)
Institute of Liver and Biliary Sciences, New Delhi
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2022
First Posted
March 24, 2022
Study Start
February 1, 2022
Primary Completion
November 30, 2022
Study Completion
November 30, 2022
Last Updated
December 5, 2023
Record last verified: 2023-10