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NAFLDNCT02006329

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

A study testing acupuncture in people with NAFLD and Accupuncture, run by Ziv Hospital at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NAFLD, Accupuncture
What is being tested?
acupuncture
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteIsrael
Study dates
Jan 2014to Nov 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Above 18 years old No known metabolic pathology NAFLD diagnosis

Who cannot join

  • Known metabolic pathology Psychiatric diagnosis Auto immune disease Known Diabetes Hypertension

Trial locations and contacts

1 site in 1 country.

Israel1 site
  • Ziv Medical Center

    Safed, Israel, 13100

    Nimer Assy, MD, 972-4-6828442, assy.n@ziv.health.gov.il

Other trials in Israel

About this study

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
Being tested
acupuncture
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02006329
Study groupRoleWhat they receive
Intervention group - dietary consultation - MeditExperimentalNot described
Receives: Device: acupuncture
Control group - dietary consultation - Mediterranean dietNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fibroscan test

    Measured: 3 months after the treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2013 (estimated)
  2. Study startJan 2014
  3. Primary completionNov 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02006329
Sponsor's protocol ID
0089-13-ziv
Status last verified
Dec 2013
First submitted
27 Nov 2013
Last updated
10 Dec 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing acupuncture in people with NAFLD and Accupuncture, run by Ziv Hospital at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nimer assy, MD (972-4-6828442, assy.n@ziv.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fibroscan test (time frame: 3 months after the treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2013.

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