Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

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 Show detailed description

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

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.




Primary Outcome Measures :
  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. [ Time Frame: Post operative day 2 ]

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


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:

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

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
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