- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00266019
Weight Management in Nonalcoholic Steatohepatitis
12 januari 2010 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
30
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Rhode Island
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Providence, Rhode Island, Förenta staterna, 02903
- Rhode Island Hospital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vad mäter studien?
Primära resultatmått
Resultatmått |
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Liver histology score (NASH-Clinical Research Network [CRN] scoring system) at 48 weeks
|
Weight reduction at 48 weeks
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Sekundära resultatmått
Resultatmått |
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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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Kittichai Promrat, M.D., Rhode Island Hospital/Brown University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2005
Avslutad studie (Faktisk)
1 december 2007
Studieregistreringsdatum
Först inskickad
14 december 2005
Först inskickad som uppfyllde QC-kriterierna
14 december 2005
Första postat (Uppskatta)
15 december 2005
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
13 januari 2010
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 januari 2010
Senast verifierad
1 januari 2010
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- DK67363 (completed)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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