- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00266019
Weight Management in Nonalcoholic Steatohepatitis
12. januar 2010 opdateret af: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Weight Management in Nonalcoholic Steatohepatitis (NASH)
Nonalcoholic steatohepatitis (NASH) is one of the most common chronic liver diseases.
The cause of NASH is not completely understood and currently there is no effective treatment for this disease.
An effective approach to treatment is needed since without treatment this disease may progress to fibrosis and cirrhosis.
Obesity is one of the most important risk factors for NASH and weight reduction is generally recommended as an initial step in its management.
However, there are very limited data on the efficacy of weight reduction as a treatment for NASH.
Data from uncontrolled trials using poorly defined primary outcome measures and patient populations and nonstandardized weight loss interventions suggest that modest weight loss may improve fatty liver disease.
The objective of this project is to conduct a randomized controlled trial of weight reduction in the management of NASH using a combination of diet, exercise, and behavior modification.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Nonalcoholic steatohepatitis (NASH) is one of the most common chronic liver diseases.
The cause of NASH is not completely understood and currently there is no effective treatment for this disease.
An effective approach to treatment is needed since without treatment this disease may progress to fibrosis and cirrhosis.
Obesity is one of the most important risk factors for NASH and weight reduction is generally recommended as an initial step in its management.
However, there has never been a randomized controlled trial evaluating the efficacy of weight reduction as a treatment for NASH.
Data from uncontrolled trials using poorly defined primary outcome measures and patient populations and nonstandardized weight loss interventions suggest that modest weight loss may improve liver histology.
The objective of this project is to conduct a pilot study in preparation for a randomized controlled trial of weight reduction in the management of NASH.
In this study, 30 overweight or obese individuals with biopsy-proven NASH will be enrolled.
Twenty patients will be randomized to receive 48 weeks of intensive weight management using a combination of diet, exercise and behavior modification with a goal of 7-10% weight reduction.
This weight loss program is similar to programs used successfully in other overweight populations and to the intensive lifestyle program of the Diabetes Prevention Program and Look AHEAD.
The other 10 patients will be randomized to a control group where they will receive standard medical care and general counseling on healthy eating and exercise.
At the end of the 48-week study, patients will have a repeat liver biopsy that will be compared to their baseline biopsy.
The pilot study will establish the feasibility of recruiting and retaining, producing sustained weight loss and performing repeat liver biopsies in this population.
Based on the outcomes of this preliminary trial, this program will be further refined and readied for a larger-scale clinical trial.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
30
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Rhode Island
-
Providence, Rhode Island, Forenede Stater, 02903
- Rhode Island Hospital
-
-
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:
- Evidence of chronic steatohepatitis on liver biopsy.
- Elevated alanine or aspartate aminotransferase values (ALT > 41 or AST > 34) within 3 months of enrollment
- Absence of another form of liver disease
- Body mass index between 25-50 kg/m2.
- At least 18 years of age
- Absence of significant alcohol consumption (more than one standard drink per day).
- Able to walk 2 blocks or a quarter of a mile without stopping
- Willing to complete a two-week run-in period with successful completion of self-monitoring records.
Exclusion Criteria:
- < 18 years of age
- Significant alcohol consumption (> 1 standard drink per day)
- Contraindications to obtaining a liver biopsy
- Unable to walk 2 blocks or a quarter of a mile without stopping
- Currently pregnant or pregnant in the previous six months
- Currently engaged in an active weight-loss program or taking weight-loss medication
- Report conditions that, in the judgment of the investigators, render potential participants unlikely to follow the protocol for 12 months, including illness likely to be terminal within 2 years, plans to move, substance abuse, or other significant psychiatric problems
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: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
---|
Liver histology score (NASH-Clinical Research Network [CRN] scoring system) at 48 weeks
|
Weight reduction at 48 weeks
|
Sekundære resultatmål
Resultatmål |
---|
Insulin sensitivity at 48 weeks
|
Liver function test at 48 weeks
|
Inflammatory markers and adipokine levels at 48 weeks
|
Quality of life at 48 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Kittichai Promrat, M.D., Rhode Island Hospital/Brown University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Kleiner DE, Brunt EM, Van Natta M, Behling C, Contos MJ, Cummings OW, Ferrell LD, Liu YC, Torbenson MS, Unalp-Arida A, Yeh M, McCullough AJ, Sanyal AJ; Nonalcoholic Steatohepatitis Clinical Research Network. Design and validation of a histological scoring system for nonalcoholic fatty liver disease. Hepatology. 2005 Jun;41(6):1313-21. doi: 10.1002/hep.20701.
- Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
- Bacon BR, Farahvash MJ, Janney CG, Neuschwander-Tetri BA. Nonalcoholic steatohepatitis: an expanded clinical entity. Gastroenterology. 1994 Oct;107(4):1103-9. doi: 10.1016/0016-5085(94)90235-6.
- Ludwig J, Viggiano TR, McGill DB, Oh BJ. Nonalcoholic steatohepatitis: Mayo Clinic experiences with a hitherto unnamed disease. Mayo Clin Proc. 1980 Jul;55(7):434-8.
- Ueno T, Sugawara H, Sujaku K, Hashimoto O, Tsuji R, Tamaki S, Torimura T, Inuzuka S, Sata M, Tanikawa K. Therapeutic effects of restricted diet and exercise in obese patients with fatty liver. J Hepatol. 1997 Jul;27(1):103-7. doi: 10.1016/s0168-8278(97)80287-5.
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
1. januar 2005
Studieafslutning (Faktiske)
1. december 2007
Datoer for studieregistrering
Først indsendt
14. december 2005
Først indsendt, der opfyldte QC-kriterier
14. december 2005
Først opslået (Skøn)
15. december 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
13. januar 2010
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. januar 2010
Sidst verificeret
1. januar 2010
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DK67363 (completed)
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 .
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