Treatment of Non Alcoholic Fatty Liver Disease With Lifestyle Modification and Acupuncture

NAFLD Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02006329
• Other study ID #: 0089-13-ziv
• Status: Not yet recruiting
• Phase: N/A
• First received: November 27, 2013
• Last updated: December 4, 2013
• Start date: January 2014

Study information

• Verified date: December 2013
• Source: Ziv Hospital
• Contact: Nimer assy, MD
• Phone: 972-4-6828442
• Email: assy.n[@]ziv.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Nonalcoholic fatty liver disease (NAFLD) is the most common cause of liver dysfunction worldwide. NAFLD may progress to nonalcoholic steatohepatitis (NASH) and in turn to cirrhosis. To date, the detailed pathogenic mechanism of NAFLD including steatosis and NASH is not fully characterized, although it is regarded as a hepatic manifestation of the metabolic syndrome, sometimes it occurs in the absence of a metabolic syndrome. Based on conventional models of "two-hit" and "multi- hit" hypothesis of NAFLD, the dysregulated lipid metabolism and insulin resistance are considered as the "first hit" of the liver and the following "second hit" or "multi-hit" likely involves oxidative stress, lipid peroxidation, increased inflammatory responses, induced hepatic fibrosis and apoptosis. This emphasizes the multi-factorial pathogenesis of NAFLD and the necessity to treat NAFLD with diabetes-like and multimodal strategy. Several changes in dietary intake have occurred in the past few years, including increased energy intake (24%), and increases in added sugars, flour and cereal products, fruit, added fats and total fat intake. The increasing prevalence of NAFLD is probably directly affected by the contemporary epidemics of obesity, unhealthy dietary pattern, and sedentary lifestyle. Currently, there are two major categories of NAFLD therapy: lifestyle interventions and pharmaceutical therapies, lifestyle interventions in terms of diet and physical activity are regarded as safe and effective, while pharmaceutical interventions showed limited efficacy with unknown safety in the long term ,therefore, the first line of treatment is lifestyle modification. Although lifestyle intervention dose positively affects NAFLD, it has limitations. Patients adherence to dietary intervention is 50%, while those who do adhere, find it difficult to maintain after 12 months. ). Mediterranean diet has been shown to be effective in reducing NAFLD, liver steatosis and improve insulin sensitivity. Acupuncture has been found as an effective treatment for improving quality of life in various medical conditions , including hepatitis . Acupuncture combined with life style intervention has been found effective in the treatment of obesity, metabolic syndrome in terms of weight, lipid regulation, glucose levels and various markers of inflammation. Acupuncture's effect on NAFLD has yet to be studied.

We suggest that acupuncture combined with life style intervention can be an effective treatment for NAFLD.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Above 18 years old No known metabolic pathology NAFLD diagnosis

Exclusion Criteria:

Known metabolic pathology Psychiatric diagnosis Auto immune disease Known Diabetes Hypertension

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Accupuncture
• NAFLD

Intervention

Device:
• acupuncture

Locations

Country	Name	City	State
Israel	Ziv Medical Center	Safed

Sponsors (1)

Lead Sponsor	Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibroscan test		3 months after the treatment