- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05428072
Alcohol, Gut Leakiness, & Liver Disease
16. juni 2022 opdateret af: Ali Keshavarzian, Rush University Medical Center
The goal of this study is to investigate the role of gut leakiness in alcoholic liver disease.
Gut leakiness may be the missing susceptibility factor that explains why some alcoholics develop liver disease and others don't.
For this study, subjects 480 (240 male, 240 female, ages 18-80) will be recruited.
Alcoholic subjects will be recruited from outpatient & inpatient alcohol detoxification units from Rush, Loyola & two halfway houses (one for women, one for men); patients with liver disease from GI/Hepatology Services at Rush, Hines VA Hosp & Loyola University; and controls from hospital staffs.
All subjects will fill out a detailed questionnaire, be interviewed by the study coordinator & undergo an exam by the PI to ensure that all inclusion criteria are satisfied.
All subjects will have a urine collection for tests of intestinal permeability (urinary sugars).
Gut leakiness will be determined by the amount of sugars in the urine.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
195
Fase
- Tidlig fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Ali Keshavarzian
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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 til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
There are 4 different categories of participants that were used for recruitment:
Healthy controls
- Subjects must have a normal physical exam
- No GI complaints
- No known liver disease
- Normal liver function tests (ALT, AST, bilirubin, alkaline phosphatase, serum albumin)
- Consume no more than a moderate amount of alcohol (NIAAA definition [1 ]).
- These subjects should not be daily drinkers (< 3x / week) and should typically drink < 3 drinks per occasion.
Alcoholics
- Subjects should fulfill NIAAA criteria for at-risk drinking & alcohol abuse or dependence & DSM-IV criteria for alcoholism
- Each must have consumed alcohol regularly for at least the past 3 mos but must be sober for 3-7 day post-binge at the time of sugar test (except for group 7)
- Have a total regular heavy drinking history of at least 10 y (except for Group 6) the minimal period of time required for the development of ALD.
These are the different alcoholic groups and their specific inclusion criteria:
ALCOHOLICS WITHOUT LIVER DISEASE
- no clinical evidence of ALD on physical examination
- serum bilirubin or ALT or AST less than 1.25X normal
- sobriety must be <7 days at the time of sugar test.
ALCOHOLICS WITH LIVER DISEASE
- These subjects will have 1 of 3 possible grades of LD severity (mild, moderate, severe) & have either clinical evidence of LD (hepatomegaly, splenomegaly, and esophageal varices), or serum bilirubin or ALT or AST more than 1.5X normal.
- If liver biopsy or CT or ultrasound is available, there should be histological evidence of LD (alcoholic hepatitis or cirrhosis) or radiological evidence of LD (cirrhotic liver, splenomegaly, varices)
- Their sobriety must be <7 days at the time of the sugar test.
ALCOHOLICS WITH SHORT-TERM Drinking
- These subjects should fulfill the criteria of alcohol abuse
- have sobriety <7 days at the time of urine collection, but the duration of their heavy drinking must be <5 years
- They must not have any liver disease (negative serology) due to non-EtOH causes or clinical evidence of
- cirrhosis. Here, liver enzyme levels are not inclusion/exclusion criteria; but since the duration of EtOH abuse (<5 y) is too short for the development of cirrhosis, it is expected that none will have sustained elevated liver enzymes.
SOBER ALCOHOLICS WITH LD .
- Criteria is the same as Alcholics with liver disease but last drink was >7 days from the study enrollment.
Subjects with Non-alcoholic liver disease
- Criteria for LD are similar to those outlined for alcoholics with liver disease subjects except that drinking history should be similar to that of healthy volunteers. Subjects after liver transplant.
- These subjects must have successful liver transplantation at least 6 mos prior to the study and are on stable doses of immunosuppression for 3 mos.
Exclusion Criteria:
- Unreliable drinking history (to rule out closet drinkers or pretenders).
- Subjects must clearly fulfill the criteria either of "alcoholism" or of "on-drinker".
- Subjects with a drinking history of 5-9 years duration are excluded since this period is not short enough to preclude cirrhosis nor long enough to cause ALD in most subjects.
- Significant renal impairment (creatinine>l.2 mg/dL
- Diseases that affect GI motility such as scleroderma.
- insulin-requiring diabetes &/or uncontrolled diabetes (Hgb-Alc>8%)
- Clinically significant dehydration.
- clinically detectable ascites
- Significant peripheral edema
- Sepsis
- Clinically significant cardiac failure
- Regular daily use of medications that may affect intestinal permeability such as NSAIDS or intestinal motility (e.g. metoclopramide).
- Alcoholics positive for other markers of LD such as smooth muscle antibody, hepatitis B surface antigen, hepatitis C antibody or hemochromatosis
- Inability to sign an informed consent form
- Patients with low platelet count (<80k), uncorrectable prolonged PT (>15 sec), history of bleeding will be excluded from aspirin tests
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: sugar test
Participants will undergo 3 sugar tests followed by
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All participants will take two sugar tests ( sugar cocktail consisting of mannitol & lactulose) subjects within 2-3 days of the initial sugar test.
All participants will take a sugar test after 2 doses of aspirin, 1.3 g each given at 12 & 1 hour before the sugar drink.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Changes in gut permeability
Tidsramme: 3 days
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All participants will consume a sugar cocktail (lactulose & mannitol) and collect their urine.
A urinary analysis was performed to measure the secretion of sugar and indicates gut permeability.
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3 days
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Changes in gut permeability after consuming aspirin
Tidsramme: 1 day
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Participants will take will consume 2 doses of aspirin, 1.3 g each given at 12 & 1 h before taking a sugar test.
A urinary analysis was performed to measure the secretion of sugar and indicates gut permeability.
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1 day
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
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)
1. januar 2003
Primær færdiggørelse (Faktiske)
1. marts 2015
Studieafslutning (Faktiske)
1. marts 2015
Datoer for studieregistrering
Først indsendt
16. juni 2022
Først indsendt, der opfyldte QC-kriterier
16. juni 2022
Først opslået (Faktiske)
22. juni 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. juni 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. juni 2022
Sidst verificeret
1. juni 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Kemisk inducerede lidelser
- Sygdomme i fordøjelsessystemet
- Alkohol-relaterede lidelser
- Stof-relaterede lidelser
- Alkohol-inducerede lidelser
- Leversygdomme
- Leversygdomme, alkohol
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystem
- Enzymhæmmere
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Fibrinolytiske midler
- Fibrinmodulerende midler
- Blodpladeaggregationshæmmere
- Cyclooxygenase-hæmmere
- Antipyretika
- Aspirin
Andre undersøgelses-id-numre
- ORA 09042105
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.
Ingen
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