NCT03544242

Brief Summary

This study seeks to investigate the effects of administering nitrite to pancreatic islet cells that have been removed from a patient for autotransplantation.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_2 diabetes

Timeline
Completed

Started May 2017

Typical duration for phase_2 diabetes

Geographic Reach
1 country

1 active site

Status
terminated

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

May 7, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 21, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 18, 2020

Completed
Last Updated

October 29, 2020

Status Verified

October 1, 2020

Enrollment Period

2.1 years

First QC Date

May 21, 2018

Results QC Date

August 3, 2020

Last Update Submit

October 7, 2020

Conditions

Diabetes

Keywords

DiabetesInsulin ResistanceNitritePancreatic islet cellsAutotransplantationIschemia reperfusion injuryMitigationCureNitric oxideSodium nitriteIslet cellSurvivalPancreasLiver

Outcome Measures

Primary Outcomes (8)

  • Prior to Infusion Blood Glucose Serum Levels

    Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.

    Between the time of induction and the time immediately prior to infusion of either nitrite or saline

  • Pre-islet Cell Infusion Blood Serum Glucose Levels

    Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.

    Five minutes prior to the infusion of islet cells

  • 20 Minutes After Islet Cells Blood Serum Glucose Levels

    Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.

    20 minutes after the infusion of Islet Cells

  • 40 Minutes After Islet Cells Blood Serum Glucose Levels

    Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.

    40 minutes after the infusion of Islet Cells

  • 24 Hours Post Operative Blood Samples Serum Glucose Levels

    Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.

    24 hours post operatively

  • 48 Hours Post Operative Blood Samples Serum Glucose Levels

    Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.

    48 hours post operatively

  • 72 Hours Post Operative Blood Samples Serum Glucose Levels

    Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.

    72 hours post operatively

  • 96 Hours Post Operative Blood Samples Serum Glucose Levels

    Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.

    96 hours post operatively

Study Arms (3)

Control group

ACTIVE COMPARATOR
Other: Control

Pre-Isolation Infusion

EXPERIMENTAL
Drug: Pre-Isolation Infusion

Post-Isolation Infusion

EXPERIMENTAL
Drug: Post-Isolation Infusion

Interventions

ControlOTHER

A saline infusion will be administered during the pre-isolation and post-isolation phases.

Control group
Pre-Isolation InfusionDRUG

A nitrite infusion will be administered during the pre-isolation phase and a saline infusion will be administered during the post-isolation phase.

Pre-Isolation Infusion
Post-Isolation InfusionDRUG

A saline infusion will be administered during the pre-isolation phase and a nitrite infusion will be administered during the reperfusion phase.

Post-Isolation Infusion

Eligibility Criteria

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

You may qualify if:

  • Patients greater than or equal to 18 years of age
  • Scheduled to undergo Islet Cell auto-transplantation by Dr. Jared White or Dr. Bart Rose
  • Subjects who can provide informed written consent and are willing to do so

You may not qualify if:

  • Any patient with liver disease or unsuitable for surgery (as determined by the surgeon)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Diabetes MellitusInsulin ResistanceReperfusion Injury

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinismVascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Adam Sturdivant, MPH
Organization
University of Alabama at Birmingham
Adamsturdivant@uabmc.edu
205-934-4042

Study Officials

  • Blair Smith, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 21, 2018

First Posted

June 1, 2018

Study Start

May 7, 2017

Primary Completion

June 27, 2019

Study Completion

June 27, 2019

Last Updated

October 29, 2020

Results First Posted

August 18, 2020

Record last verified: 2020-10

Locations

US(1)