- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03544242
Nitrite Infusion in Islet Cell Transplantation
7. oktober 2020 opdateret af: Blair Smith, University of Alabama at Birmingham
Nitrite Infusion in Islet Cell Transplantation: Test of Clinical Efficacy and Determination of Cytoprotective Mechanisms
This study seeks to investigate the effects of administering nitrite to pancreatic islet cells that have been removed from a patient for autotransplantation.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Patients diagnosed with chronic pancreatitis or recurrent acute pancreatitis may acquire insulin-dependent diabetes due to islet cell destruction.
Therefore, islet cell autotransplantation is the optimal therapeutic approach for many of these patients.
Islet cell autotransplantation is typically done by excision of the pancreas, followed by isolation of the islet cells and then infusion of these cells into the sinusoids of the liver.
Isolation of the islet cells occurs in an ischemic and hypoxic environment, resulting in ischemia reperfusion (IR) injury and destruction of islet cells following infusion into the sinusoids.
Hence, strategies to prevent IR injury and subsequent islet cell destruction, such as the administration of inhaled nitric oxide (NO) or sodium nitrite (NaNO2) could enhance islet cell survival following reperfusion, also decreasing long-term insulin requirement.
The purpose of this study is to determine if NO administered by infusion in patients undergoing islet cell auto transplantation, will inhibit islet cell destruction, increase diabetes cure rate (decrease the amount of and/or the need for long-term insulin requirement), decrease the ischemic injury (reduces the injury to the islet cells from a decrease in oxygen levels during procurement of the islet cells) during islet cell procurement, and decrease IR injury following islet cell infusion.
The primary endpoints of the study are exogenous insulin use, HgbA1c levels post-operatively, and blood glucose levels.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
4
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Alabama
-
Birmingham, Alabama, Forenede Stater, 35294
- University of Alabama at Birmingham
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
-Any patient with liver disease or unsuitable for surgery (as determined by the surgeon)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Kontrolgruppe
|
A saline infusion will be administered during the pre-isolation and post-isolation phases.
|
Eksperimentel: Pre-Isolation Infusion
|
A nitrite infusion will be administered during the pre-isolation phase and a saline infusion will be administered during the post-isolation phase.
|
Eksperimentel: Post-Isolation Infusion
|
A saline infusion will be administered during the pre-isolation phase and a nitrite infusion will be administered during the reperfusion phase.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Prior to Infusion Blood Glucose Serum Levels
Tidsramme: Between the time of induction and the time immediately prior to infusion of either nitrite or saline
|
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
Tidsramme: Five minutes prior to the infusion of islet cells
|
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
Tidsramme: 20 minutes after the infusion of Islet Cells
|
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
Tidsramme: 40 minutes after the infusion of Islet Cells
|
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
Tidsramme: 24 hours post operatively
|
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
Tidsramme: 48 hours post operatively
|
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
Tidsramme: 72 hours post operatively
|
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
Tidsramme: 96 hours post operatively
|
Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.
|
96 hours post operatively
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Blair Smith, MD, University of Alabama at Birmingham
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
7. maj 2017
Primær færdiggørelse (Faktiske)
27. juni 2019
Studieafslutning (Faktiske)
27. juni 2019
Datoer for studieregistrering
Først indsendt
21. maj 2018
Først indsendt, der opfyldte QC-kriterier
21. maj 2018
Først opslået (Faktiske)
1. juni 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. oktober 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. oktober 2020
Sidst verificeret
1. oktober 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- IRB-160901003
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ja
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Control
-
Indiana UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...RekrutteringSvangerskabsforebyggelse | Udnyttelse af sundhedsvæsenet | PræventionsbrugForenede Stater
-
University of California, San FranciscoTrukket tilbage
-
Singapore General HospitalDuke-NUS Graduate Medical SchoolUkendtFjern iskæmisk konditionering på blodtrykskontrol hos patienter med kronisk nyresygdom (ERIC-BP-CKD)Hjerte-kar-sygdomme | Forhøjet blodtryk | Kroniske nyresygdommeSingapore
-
Essilor InternationalAktiv, ikke rekrutterende
-
University of UtahJohns Hopkins University; Arizona State University; National Multiple Sclerosis...AfsluttetMultipel sclerose | Svimmelhed | Svimmelhed | FaldskadeForenede Stater
-
University Hospital, BrestRekruttering
-
Istanbul Medipol University HospitalAktiv, ikke rekrutterende
-
Instituto Sexológico MurcianoHospital Virgen del Alcazar de LorcaAfsluttetFor tidlig ejakulation | Medicinsk udstyr | OnaniSpanien
-
AllerganAfsluttet
-
University of California, San FranciscoUniversity of California, BerkeleyAfsluttet