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

NCT ID: NCT02006329

Last Updated: 2013-12-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31

Brief 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.

Conditions

NAFLD; Accupuncture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group - dietary consultation - Medit

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: DEVICE

Control group - dietary consultation - Mediterranean diet

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

acupuncture

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ziv Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Assy Nimer

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ziv Medical Center

Safed, Israel, Israel

Countries

Israel

Central Contacts

Nimer assy, MD

Role: CONTACT

Phone: 972-4-6828442

Email: assy.n@ziv.health.gov.il

Facility Contacts

Nimer Assy, MD

Role: primary

Other Identifiers

0089-13-ziv

Identifier Type: -

Identifier Source: org_study_id