Efficacy and Safety of Diamel in Patients With Nonalcoholic Steatohepatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-04-30

Brief Summary

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The purpose of the study is to evaluate whether the addition of Diamel, a nutritional supplement, to hypocaloric diet and exercise could improve the histological results (steatosis, necro-inflammatory activity and fibrosis), insulin resistance, aminotransferase levels and anthropometric measures in comparison with a placebo-controlled group with hypocaloric diet and exercise during 52 weeks of treatment in patients with nonalcoholic steatohepatitis.

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Detailed Description

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Conditions

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Nonalcoholic Steatohepatitis Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo and lifestyle counseling

Intervention Type OTHER

Hypocaloric diet of 1620 kcal daily (The dietary pattern will be distributed in carbohydrates 64%, fat 22% with \<10% of saturated fatty acids and protein 14%, and exercise)

Diamel

Group Type EXPERIMENTAL

Diamel

Intervention Type DIETARY_SUPPLEMENT

Diamel, a nutritional supplement, 2 oral pills (660 mg), every 8 hours, daily, during 52 weeks

Interventions

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Diamel

Diamel, a nutritional supplement, 2 oral pills (660 mg), every 8 hours, daily, during 52 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo and lifestyle counseling

Hypocaloric diet of 1620 kcal daily (The dietary pattern will be distributed in carbohydrates 64%, fat 22% with \<10% of saturated fatty acids and protein 14%, and exercise)

Intervention Type OTHER

Other Intervention Names

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Dietary supplement Placebo Lifestyle modification

Eligibility Criteria

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Inclusion Criteria

* Histological diagnosis of steatohepatitis (minimal histological criteria for steatohepatitis include steatosis involving at least 5% of hepatocytes, lobular inflammation, and/or fibrosis)
* Age between 18 and 70 years
* Ability to provide informed consent
* Absence of significant alcohol ingestion (weekly ethanol consumption of less than 40 g)

Exclusion Criteria

* Presence of other form of liver diseases (viral or autoimmune hepatitis, drug-induced liver disease, metabolic and hereditary liver disease and α-1 antitrypsin deficiency)
* Pregnancy or lactation
* Decompensated cirrhosis
* Presence of secondary cause of NAFL such as medications that induce steatosis (corticosteroids, estrogens, methotrexate, amiodarone, tamoxifen and calcium channel blockers) and gastrointestinal bypass surgery
* Pharmacological treatment with some potential benefit on NAFL including ursodeoxycholic acid, vitamin E, betaine, pioglitazone, rosiglitazone, metformin, pentoxifylline or gemfibrozil
* Fasting glucose levels greater than 250 mg per deciliter (13.3 mmolm per liter)
* Contraindication to liver biopsy
* Refusal to participate in the study
* Concomitant disease with reduced life expectancy
* Severe psychiatric conditions
* Drug dependence

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No