- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02348814
Development of a Novel Biomarker for Liver Fibrosis
Přehled studie
Postavení
Podmínky
Detailní popis
Preliminary data suggest that cholesterol and retinoid metabolism are tightly linked in these cells, prompting us to examine this relationship in the setting of obesity and diabetes. Specific aims have been developed to test the following hypotheses: 1) Quantifying liver fibrosis as a continuous variable will predict clinically significant outcomes in fatty liver disease related to metabolic syndrome; and 2) In a prospective cohort of patients, quantified liver fibrosis will correlate more strongly with tissue and circulating retinoid metabolites than with other, commonly measured serum markers.
This study offers a major innovation by performing accurate fibrosis quantification without any human intervention or post-analysis correction. In addition, we can test whether subtle differences in quantified fibrosis impact outcome for a given clinical stage of disease severity, possible because we are measuring fibrosis as a continuous variable, not a categorical one. We are using a disease-independent approach to evaluate anti-fibrotic agents in clinical trials and for evaluating other diagnostic markers.
We are also testing whether a novel diagnostic marker, retinoid storage, correlates with liver disease progression in humans. We propose to extend the study to address fatty liver disease, NAFLD/NASH, in the context of adult patients with abnormal liver tests, fatty liver identified on imaging, physical obesity, and diabetes. Clinical variables and outcomes to be recorded and analyzed include: morphology (age, gender, ethnicity, height, weight/BMI, waist circumference and steatosis on imaging studies); biochemistry (glucose intolerance or diabetes, complete blood counts, metabolic panels, liver function tests, cholesterol panels, insulin, and vitamin D levels); clinical outcomes (date of liver disease diagnosis and estimated duration of disease, listing on liver transplant list, occurrence of liver transplant or re-transplant, presence of cancer, and death); medications (current or previous prescribed, herbals, supplements taken for diabetes, dyslipidemia, hypertension, cardiovascular disease, or stroke); and disease exacerbation/modifying factors (presence of other chronic liver diseases such as NASH + HIV, liver toxins such as alcohol consumption, weight gain, or worsening diabetes).
Data will be collected from subjects who complete eight visits over a 24-month period. Assessments will include morphometric measurements, blood collection for laboratory analysis and completion of dietary history report.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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California
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Los Angeles, California, Spojené státy, 90095
- UCLA Clinical and Translational Research Center (CTRC)
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Age >/= 18 years
- At least one liver function test abnormality (AST/SGOT, ALT/SOT, alkaline phosphatase, or bilirubin) defined as a value outside of the normal range at UCLA clinical labs. This must be present on at least two occasions within a 24 month consecutive period
- Any body mass index > 20
- One of the following:
- Clinical indication, according to standard of care assessment, for undergoing image-guided percutaneous (or transjugular) liver biopsy
- Eligible for weight loss (bariatric) surgery with fatty liver disease
- NAFLD/NASH patient who meets the above criteria and has already undergone a liver biopsy for diagnosis and disease staging
- NAFLD/NASH patient who meets above criteria but chooses not to participate in the liver biopsy, extra blood draws or the dietary assessment for the study.
Exclusion Criteria:
- Age < 18 years
- Current pregnancy
- Significant clinical co-morbidities that would preclude getting either a percutaneous or transjugular liver biopsy (i.e. platelets < 50, 000 or International Normalized Ratio (INR) > 1.5 or Hemoglobin < 8)
- Unwilling or unable to participate or consent.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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normal weight
BMI 20-25
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overweight
BMI 25-30
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obese
BMI 30-35
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morbidly obese
BMI > 35
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non-diabetic
HgbA1c (<5.7%) and blood glucose (65-99 mg/dL) within normal range as defined at UCLA Clinical Lab
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diabetic
HgbA1c (>6.5%) and blood glucose (>100 mg/dL) as defined at UCLA Clinical Lab
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non-cirrhotic
Normal liver function tests (AST/SGOT, ALT, SGPT, alkaline phosphatase, bilirubin) as defined at UCLA Clinical Lab
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dyslipidemic
Abnormal lipid profile (Total cholesterol >170 mg/dL, LDL >100 mg/dL, HDL >130 mg/dL, triglycerides >150 mg/dL) as defined at UCLA Clinical Lab
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Composite of Clinical Outcomes-change over time
Časové okno: Participants will be followed up to 24 months; measured outcomes at 8 timepoints
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Date of liver disease diagnosis and estimated duration of disease, listing on liver transplant list, occurrence of liver transplant or re-transplant, presence of cancer (liver-related or otherwise), and death
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Participants will be followed up to 24 months; measured outcomes at 8 timepoints
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Composite of Morphometric Outcomes-change over time
Časové okno: Participants will be followed up to 24 months; measured outcomes at 8 timepoints
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height, weight (BMI), waist circumference, and steatosis (fat) on imaging studies
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Participants will be followed up to 24 months; measured outcomes at 8 timepoints
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Composite of Biochemical Outcomes-change over time
Časové okno: Participants will be followed up to 24 months; measured outcomes at 8 timepoints
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presence of glucose intolerance or diabetes, complete blood counts with differential, complete metabolic panels with liver function tests, cholesterol panels, insulin, C-reactive protein, vitamin D levels, and hepatocellular carcinoma or other solid tumor cancer markers
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Participants will be followed up to 24 months; measured outcomes at 8 timepoints
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Simon Beaven, MD/PhD, UCLA Dept of Medicine, Division of Digestive Diseases
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- UL1TR000124-2016
- UL1TR000124 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
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