Low Glycemic Index Dietary Intervention Program in Nonalcoholic Fatty Liver Disease - Full Text View

Sponsored by:	Chinese University of Hong Kong
Information provided by:	Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00868933

Purpose

Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in affluent countries. It may progress to cirrhosis and liver cancer.

At present, there is no approved drug for NAFLD. Although healthy diet and exercise is often recommended, there is little supportive evidence. Therefore, the investigators plan to conduct a randomized controlled trial comparing a low glycemic index dietary intervention program and simple lifestyle advice in NAFLD patients. The primary endpoint is resolution of NAFLD. Non-invasive tests will be used to assess the study subjects. Proton-magnetic resonance spectroscopy is used to quantify hepatic triglyceride content, and transient elastography is used to quantify liver fibrosis.

Condition	Intervention
Nonalcoholic Fatty Liver Disease	Other: Low glycemic index dietary intervention program Other: simple lifestyle advice

MedlinePlus related topics: Diets Liver Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Low Glycemic Index Dietary Intervention Program in Nonalcoholic Fatty Liver Disease - A Randomized Controlled Trial

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:

Resolution of NAFLD by proton-magnetic resonance spectroscopy [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Partial resolution of NAFLD [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
Visceral fat measurement [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
Liver fibrosis by transient elastography [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
Metabolic endpoints [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	February 2009
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Low glycemic index dietary intervention program: Active Comparator The intervention group involves dietary advice and monitoring. No drug or invasive procedure is involved.	Other: Low glycemic index dietary intervention program The intervention group involves dietary advice and monitoring. No drug or invasive procedure is involved.
Simple lifestyle advice: Placebo Comparator The control group receives lifestyle advice from a clinician, and the clinical care is not inferior to current practice.	Other: simple lifestyle advice The control group receives lifestyle advice from a clinician, and the clinical care is not inferior to current practice.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18 to 70 years
Fatty liver by proton-magnetic resonance spectroscopy, defined as hepatic triglyceride content 5% or above
Serum alanine aminotransferase (ALT) above 30 U/L in men and 19 U/L in women
Informed written consent obtained

Exclusion Criteria:

Positive hepatitis B surface antigen, anti-hepatitis C virus antibody, or anti-nuclear antibody titer above 1/160
Alcohol consumption above 30 g per week in men or 20 g per week in women
Alanine aminotransferase (ALT) above 10 times the upper limit of normal
Liver decompensation, as evidenced by bilirubin above 50 µmol/l, platelet count below 100 × 10e9/l, prothrombin time above 1.3 times the upper limit of normal, albumin below 35 g/l, presence of ascites or varices
Evidence of hepatocellular carcinoma
Terminal illness or cancer, unless in complete remission for more than 5 years

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868933

Contacts

Contact: Vincent WS Wong, MD	26323387	wongv@cuhk.edu.hk
Contact: Angel ML Chim, MSc	26324205	angelchim@cuhk.edu.hk

Locations

China
Cheng Suen Man Shook Hepatitis Center, Institute of Digestive Disease, The Chinese University of Hong Kong, Prince of Wales Hospital	Recruiting
Hong Kong SAR, China
Contact: Vincent WS Wong, MD (852)26323387 wongv@cuhk.edu.hk
Contact: Angel Ml Chim, MSc (852)26324205 angelchim@cuhk.edu.hk
Sub-Investigator: Grace LH Wong, Dr
Sub-Investigator: Jean Woo, MD, FRCP
Sub-Investigator: Ruth Chan, PhD
Sub-Investigator: Winnie Chu, MD, FRCR

Sponsors and Collaborators

Chinese University of Hong Kong

More Information

Publications:

Farrell GC, Larter CZ. Nonalcoholic fatty liver disease: from steatosis to cirrhosis. Hepatology. 2006 Feb;43(2 Suppl 1):S99-S112. Review.

Wong VW, Chan HL, Hui AY, Chan KF, Liew CT, Chan FK, Sung JJ. Clinical and histological features of non-alcoholic fatty liver disease in Hong Kong Chinese. Aliment Pharmacol Ther. 2004 Jul 1;20(1):45-9.

Wong VW, Wong GL, Chim AM, Tse AM, Tsang SW, Hui AY, Choi PC, Chan AW, So WY, Chan FK, Sung JJ, Chan HL. Validation of the NAFLD fibrosis score in a Chinese population with low prevalence of advanced fibrosis. Am J Gastroenterol. 2008 Jul;103(7):1682-8. Epub 2008 Jul 4.

Hui AY, Wong VW, Chan HL, Liew CT, Chan JL, Chan FK, Sung JJ. Histological progression of non-alcoholic fatty liver disease in Chinese patients. Aliment Pharmacol Ther. 2005 Feb 15;21(4):407-13.

Caldwell SH, Oelsner DH, Iezzoni JC, Hespenheide EE, Battle EH, Driscoll CJ. Cryptogenic cirrhosis: clinical characterization and risk factors for underlying disease. Hepatology. 1999 Mar;29(3):664-9.

Wong VW, Hui AY, Tsang SW, Chan JL, Tse AM, Chan KF, So WY, Cheng AY, Ng WF, Wong GL, Sung JJ, Chan HL. Metabolic and adipokine profile of Chinese patients with nonalcoholic fatty liver disease. Clin Gastroenterol Hepatol. 2006 Sep;4(9):1154-61. Epub 2006 Aug 14.

Targher G, Bertolini L, Rodella S, Tessari R, Zenari L, Lippi G, Arcaro G. Nonalcoholic fatty liver disease is independently associated with an increased incidence of cardiovascular events in type 2 diabetic patients. Diabetes Care. 2007 Aug;30(8):2119-21. Epub 2007 May 22. No abstract available.

Wong VW, Hui AY, Tsang SW, Chan JL, Wong GL, Chan AW, So WY, Cheng AY, Tong PC, Chan FK, Sung JJ, Chan HL. Prevalence of undiagnosed diabetes and postchallenge hyperglycaemia in Chinese patients with non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2006 Oct 15;24(8):1215-22.

Belfort R, Harrison SA, Brown K, Darland C, Finch J, Hardies J, Balas B, Gastaldelli A, Tio F, Pulcini J, Berria R, Ma JZ, Dwivedi S, Havranek R, Fincke C, DeFronzo R, Bannayan GA, Schenker S, Cusi K. A placebo-controlled trial of pioglitazone in subjects with nonalcoholic steatohepatitis. N Engl J Med. 2006 Nov 30;355(22):2297-307.

Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med. 2007 Jun 14;356(24):2457-71. Epub 2007 May 21. Erratum in: N Engl J Med. 2007 Jul 5;357(1):100.

Chan HL, de Silva HJ, Leung NW, Lim SG, Farrell GC; Asia-Pacific Working Party on NAFLD. How should we manage patients with non-alcoholic fatty liver disease in 2007? J Gastroenterol Hepatol. 2007 Jun;22(6):801-8. Review.

Chan HL, Wong VW. Can dietetic intervention for obesity ever succeed in real life? J Gastroenterol Hepatol. 2007 Apr;22(4):459-60. No abstract available.

Ludwig DS. Clinical update: the low-glycaemic-index diet. Lancet. 2007 Mar 17;369(9565):890-2. Review. No abstract available.

Woo J, Sea MM, Tong P, Ko GT, Lee Z, Chan J, Chow FC. Effectiveness of a lifestyle modification programme in weight maintenance in obese subjects after cessation of treatment with Orlistat. J Eval Clin Pract. 2007 Dec;13(6):853-9.

Responsible Party:	The Chinese University of Hong Kong ( Professor Vincent WS Wong )
Study ID Numbers:	NAFLD-Diet
Study First Received:	March 24, 2009
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00868933 History of Changes
Health Authority:	Hong Kong: Department of Health

Study placed in the following topic categories:

Liver Diseases
Non-alcoholic Steatohepatitis (NASH)
Digestive System Diseases
Fatty Liver

Additional relevant MeSH terms:

Liver Diseases
Digestive System Diseases
Fatty Liver

ClinicalTrials.gov processed this record on May 07, 2009