Obesity Clinical Trial
Official title:
The European NAFLD Registry
The European NAFLD Registry is a prospectively recruited, observational study supporting the study of the clinical phenotype, natural history, disease outcomes and pathophysiology of Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis. The ultimate goals are to better understand the drivers of interpatient variation in disease pathophysiology and severity and to utilise this information to develop and validate biomarkers that, singly or in combination, enable detection and monitoring of disease progression and/or from NAFL through NASH to fibrosis and cirrhosis.
Status | Recruiting |
Enrollment | 10000 |
Est. completion date | December 31, 2030 |
Est. primary completion date | December 31, 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: 1. Age =18 years. 2. Clinically suspected NAFLD based on any of: 1. Patient with historical liver biopsy providing histological evidence of NAFLD or, 2. Patient undergoing liver biopsy for suspected NAFLD with biochemical and/or radiological findings consistent with NAFLD or, 3. Patient with radiological evidence of cirrhosis (in absence of an alternative aetiology) plus presence of =2 features indicative of the 'metabolic syndrome': - Increased waist circumference by ethnically adjusted criteria (e.g. Europid male/female =94cm/80cm) or overweight/obese (BMI =25); - Raised fasting glucose =100 mg/dL [5.6 mmol/L], HbA1c =48mmol/mol (6.5%) or previously diagnosed insulin resistance/type 2 diabetes mellitus (or on treatment); - Dyslipidaemia (fasting TG level =150 mg/dL [1.7 mmol/L]; or fasting HDL <40 mg/dL [1.03 mmol/L] in males and <50 mg/dL [1.29 mmol/L] in females; or on treatment); - Hypertension (systolic BP =130 or diastolic BP =85 mmHg, or on treatment). 3. Average alcohol consumption less than 21/14 units/week (males/females) in preceding 6 months and no history of sustained excessive consumption of alcohol in past 5 years. Exclusion Criteria 1. Refusal or inability (lack of capacity) to give informed consent. 2. Average alcohol ingestion greater than approximately 21/14 units/week (males/females) in preceding 6 months or history of sustained excessive consumption of alcohol in past 5 years. 3. History or presence of Type 1 diabetes mellitus. 4. Presence of any other form of chronic liver disease except NAFLD. 5. Recent (within 12 months) or concomitant use of agents known to cause hepatic steatosis (long-term systemic corticosteroids [>10 days], amiodarone, methotrexate, tamoxifen, tetracycline, high dose oestrogens, valproic acid). 6. Any contra-indication to liver biopsy. 7. Recent (within 3 months) change in dose/regimen or introduction of Vitamin E (at a dose =400 IU/day), betaine, s-adenosyl methionine, ursodeoxycholic acid, silymarin or pentoxifylline. 8. Non-English speaking/unable to access an interpreter. Due to the nature of the study, English language or access to a relevant interpreter is a necessary criterion to ensure lifestyle (diet and exercise) and symptom data are collated. 9. Patients not meeting inclusion criteria or judged by the investigator to be unsuitable for inclusion in the study. |
Country | Name | City | State |
---|---|---|---|
Belgium | Universitair Ziekenhuis Antwerpen | Antwerp | |
Finland | Helsinki University Hospital | Helsinki | |
France | Le Centre de Recherche Clinique (CRC) du CHU d'Angers | Angers | |
France | Institut ICAN - Institute of Cardiometabolism And Nutrition Hôpital de la Pitié Salpêtrière | Paris | |
Germany | UNIVERSITÄTSKLINIKUM der RWTH Aachen | Aachen | |
Germany | Charité University Hospital Berlin | Berlin | |
Germany | Universitätsklinikum Freiburg | Freiburg | |
Germany | UNIVERSITÄTSMEDIZIN der Johannes Gutenberg Universität Mainz | Mainz | |
Germany | Universitätsklinikums Würzburg | Würzburg | |
Greece | Laiko General Hospital of Athens | Athens | |
Italy | Polytechnic University of Marche | Ancona | |
Italy | Università degli Studi Milano | Milan | |
Italy | Università di Palermo | Palermo | |
Italy | Università Cattolica del Sacro Cuore | Rome | |
Italy | Department of Medical Sciences University of Torino | Turin | |
Netherlands | Amsterdam UMC | Amsterdam | |
Portugal | Hospital de Santa Maria | Lisboa | |
Spain | Vall d'Hebron University Hospital | Barcelona | |
Spain | Biodonostia Health Research Institute | Donostia | |
Spain | Puerta de Hierro University Hospital | Majadahonda | |
Spain | Marqués de Valdecilla University Hospital | Santander | |
Spain | Institute of Biomedicine of Sevilla (IBiS), Virgen del Rocío University Hospital | Sevilla | |
Spain | HU Clínico de Valladolid | Valladolid | |
Sweden | Karolinska Universitetssjukhuset | Huddinge | |
Sweden | Linköping University Hospital | Linköping | |
Switzerland | Inselspital, University Hospital | Bern | |
United Kingdom | University Hospitals Birmingham Nhs Foundation Trust | Birmingham | |
United Kingdom | Addenbrooke'S Hospital | Cambridge | |
United Kingdom | Queen Elizabeth Hospital | Gateshead | |
United Kingdom | Hull Royal Infirmary | Hull | |
United Kingdom | Royal London Hospital, Barts Health NHS Trust | London | |
United Kingdom | St George's University Hospitals | London | |
United Kingdom | The Newcastle Upon Tyne Hospitals Nhs Foundation Trust | Newcastle-upon Tyne | |
United Kingdom | Queen'S Medical Centre | Nottingham | |
United Kingdom | Oxford University Hospitals Nhs Foundation Trust | Oxford | |
United Kingdom | Derriford Hospital | Plymouth | |
United Kingdom | Queen Alexandra Hospital | Portsmouth |
Lead Sponsor | Collaborator |
---|---|
Newcastle University | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Assistance Publique - Hôpitaux de Paris, Catholic University of the Sacred Heart, Institute of Cardiometabolism and Nutrition, France, Linkoeping University, Medical University of Vienna, National and Kapodistrian University of Athens, Newcastle-upon-Tyne Hospitals NHS Trust, Örebro University, Sweden, RWTH Aachen University, UMC Utrecht, University Hospital, Antwerp, University Medical Center Mainz, University of Angers, University of Bern, University of Birmingham, University of Cambridge, University of Florence, University of Helsinki, University of Lisbon, University of Milan, University of Nottingham, University of Oxford, University of Palermo, University of Turin, Italy, Wuerzburg University Hospital |
Belgium, Finland, France, Germany, Greece, Italy, Netherlands, Portugal, Spain, Sweden, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Detailed Characterisation of the NAFLD Patient Phenotype | Prospective patient recruitment and collection of cross-sectional clinical data is undertaken (including clinical biochemistry/haematology, liver histology, comorbidities, prescribed medication and imaging data).These data will be used to determine number of participants exhibiting specific features of NAFLD/NASH disease severity at enrolment including: histological grade of disease and fibrosis stage (assessed using the well validated NASH Clinical Research Network "NAFLD Activity Score" [NAS] and the FLIP "Steatosis - Activity - Fibrosis" [SAF] systems), frequency of common metabolic comorbidities (eg type 2 diabetes mellitus, dyslipidaemia, cardiovascular disease), and associated changes in clinical biochemistry/haematology/imaging parameters. Biological samples to support clinical and translational research into disease pathophysiology (e.g. genetic, epigenetic, transcriptomic, metabolomic, proteomic and metagenomic datasets) and biomarker development/validation will be collected. | 1 day | |
Secondary | Disease Natural History | Longitudinal follow-up of patients with NAFLD by annual review to characterise disease natural history and determine number of participants experiencing clinically significant events including the occurrence and timing of incident comorbidities and key target conditions of interest such as:
Death (cause of death) Major Adverse Cardiovascular Events (MACE) Hepatic (e.g. diagnosis of cirrhosis, hepatic decompensation, hepatocellular carcinoma, transplantation) Other (diagnosis of extra-hepatic malignancy/emergency hospitalisation) Routine clinical data generated as part of standard care will be collected annually. Clinical parameters assessed for changes indicative of alteration in disease state during follow-up include: clinical biochemistry/haematology, liver histology, comorbidities, prescribed medication and imaging data. Biological samples to support translational research into disease pathophysiology and biomarker development/validation will also be collected. |
Through to study completion, an average of 5 years | |
Secondary | Lifestyle factors: Dietary Habits | Cross-sectional and longitudinal study of dietary habits in patients with NAFLD using: Mediterranean Diet Score. | Through study completion, an average of 5 years | |
Secondary | Lifestyle factors: Activity/Exercise | Cross-sectional and longitudinal study of lifestyle factors (e.g. activity/sedentary behaviour/exercise levels) in patients with NAFLD using: International Physical Activity Questionnaire (IPAQ). | Through study completion, an average of 5 years | |
Secondary | Health Related Quality of Life: CLDQ | Cross-sectional and longitudinal collection of standardised data on HRQOL and symptom burden in patients with NAFLD using Patient Reported Outcome Measure (PROM): Chronic Liver Disease Questionnaire for NAFLD NASH (CLDQ NAFLD-NASH). | Through study completion, an average of 5 years | |
Secondary | Health Related Quality of Life: EQ5D5L | Cross-sectional and longitudinal collection of standardised data on HRQOL and symptom burden in patients with NAFLD using Patient Reported Outcome Measure (PROM): EQ-5D-5L Health | Through study completion, an average of 5 years | |
Secondary | Health Related Quality of Life: NASH-CHECK | Cross-sectional and longitudinal collection of standardised data on HRQOL and symptom burden in patients with NAFLD using Patient Reported Outcome Measure (PROM): NASH-CHECK. | Through study completion, an average of 5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04243317 -
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
|
N/A | |
Recruiting |
NCT04101669 -
EndoBarrier System Pivotal Trial(Rev E v2)
|
N/A | |
Terminated |
NCT03772886 -
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
|
N/A | |
Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
Recruiting |
NCT06019832 -
Analysis of Stem and Non-Stem Tibial Component
|
N/A | |
Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
Completed |
NCT04513769 -
Nutritious Eating With Soul at Rare Variety Cafe
|
N/A | |
Withdrawn |
NCT03042897 -
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Recruiting |
NCT05917873 -
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
|
N/A | |
Active, not recruiting |
NCT04353258 -
Research Intervention to Support Healthy Eating and Exercise
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
Completed |
NCT01870947 -
Assisted Exercise in Obese Endometrial Cancer Patients
|
N/A | |
Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Recruiting |
NCT05371496 -
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
|
Phase 2 |