NCT01211730

Brief Summary

Many but not all studies have shown improvement in morbidity and mortality with intensive glycemic management postoperatively. In this study, the investigators propose to determine whether improved glycemic control using intensive insulin treatment immediately postoperatively will improve outcomes in patients undergoing liver transplant using a prospective, controlled, randomized, parallel-group study design targeting two different glucose levels, 140 and 180 mg/dL.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2010

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
8 months until next milestone

Results Posted

Study results publicly available

December 23, 2016

Completed
Last Updated

December 23, 2016

Status Verified

October 1, 2016

Enrollment Period

6.7 years

First QC Date

September 28, 2010

Results QC Date

September 12, 2016

Last Update Submit

October 31, 2016

Conditions

Evidence of Liver TransplantationHyperglycemiaRejection

Keywords

LivertransplantationGlucoseHyperglycemiaInsulinRejectionHypoglycemia

Outcome Measures

Primary Outcomes (1)

  • Rejection of Liver Transplant

    Liver transplant rejection determined by either biopsy or clinical criteria (\>2x transaminases, clinical decision, treatment with high dose steroids and other anti-rejection medications

    within 1 year of transplantation

Secondary Outcomes (5)

  • Hypoglycemia

    Within first 3 days following transplantation

  • Infection Rates

    Within 1 year following transplantation

  • Rehospitalization Rates

    Within 1 year following transplantation

  • Overall Graft Survival at 1 Year

    1 year following transplantation

  • Death Within 1 Year

    1 year

Study Arms (2)

140 Group

ACTIVE COMPARATOR

Insulin treatment to target blood glucose at 140 mg/dl

Drug: Insulin

180 Group

ACTIVE COMPARATOR

Insulin treatment to target blood glucose at 180 mg/dl

Drug: Insulin

Interventions

InsulinDRUG

Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.

Also known as: glargine insulin, aspart insulin, Lantus insulin, Novolog insulin, Detemir insulin, Levemir insulin
140 Group180 Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Require Liver Transplantation
  • Age 18 - 80
  • Able to give informed consent personally or via a family member who has appropriate authorization to do so if patient unconscious.
  • Expected survival following transplantation for \> 1 year.
  • Glucose level over 180 mg/dL postoperatively

You may not qualify if:

  • Inability of patient or family member to give informed consent
  • Not expected to survive for \> 1 year following liver transplantation.
  • Previous liver transplantation
  • Acute liver failure
  • Living related donor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3.

    PMID: 37526194DERIVED

MeSH Terms

Conditions

HyperglycemiaRejection, PsychologyInsulin ResistanceHypoglycemia

Interventions

InsulinInsulin GlargineInsulin AspartInsulin Detemir

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesSocial BehaviorBehaviorHyperinsulinism

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, Long-ActingInsulin, Short-Acting

Limitations and Caveats

Single-center study with experienced nurses, glucose management service and endocrinologists. May not be applicable to other care settings

Results Point of Contact

Title
Mark E. Molitch, M.D.
Organization
Northwestern University Feinberg School of Medicine
molitch@northwestern.edu
312 503-4130

Study Officials

  • Mark E Molitch, M.D.

    Northwestern University Feinberg School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

September 28, 2010

First Posted

September 29, 2010

Study Start

April 1, 2009

Primary Completion

December 1, 2015

Study Completion

May 1, 2016

Last Updated

December 23, 2016

Results First Posted

December 23, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)