Efficacy and Safety of Diamel in Patients With Nonalcoholic Steatohepatitis

Study Overview
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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.

Official Title
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Efficacy and Safety of Diamel, a Nutritional Supplement, in Patients With Nonalcoholic Steatohepatitis. A Randomized and Double Blind Controlled Study

Conditions
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Nonalcoholic Steatohepatitis, Insulin Resistance

Intervention / Treatment
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* Dietary Supplement: Diamel
* Other: Placebo and lifestyle counseling


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Other: Placebo and lifestyle counseling<br>* 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)<br>* Other names: Lifestyle modification;|
| Experimental: Diamel<br> | Dietary Supplement: Diamel<br>* Diamel, a nutritional supplement, 2 oral pills (660 mg), every 8 hours, daily, during 52 weeks<br>* Other names: Dietary supplement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The histological improvement (steatosis, necro-inflammatory activity and fibrosis) at 52 weeks (end of the treatment) as compared with pre-treatment liver biopsy. |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulinresistance levels (HOMA-IR) at 52 weeks (end of the treatment), Aminotransferase levels at 52 weeks (end of the treatment), Body weight, Body Mass Index and waist circumference at 52 weeks (end of the treatment) |  | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nonalcoholic steatohepatitis, Insulinresistance, Diet and exercise, Nutritional supplement, Nonalcoholic fatty liver disease, Lifestyle modifications