Efficacy and Safety of Diamel in Patients With Nonalcoholic Steatohepatitis
This study has been completed.
Sponsor:
Catalysis SL
Information provided by (Responsible Party):
Catalysis SL
ClinicalTrials.gov Identifier:
NCT00820651
First received: January 9, 2009
Last updated: April 25, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Nonalcoholic Steatohepatitis Insulin Resistance |
Dietary Supplement: Diamel Other: Placebo and lifestyle counseling |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Efficacy and Safety of Diamel, a Nutritional Supplement, in Patients With Nonalcoholic Steatohepatitis. A Randomized and Double Blind Controlled Study |
Resource links provided by NLM:
Further study details as provided by Catalysis SL:
Primary Outcome Measures:
- The histological improvement (steatosis, necro-inflammatory activity and fibrosis) at 52 weeks (end of the treatment) as compared with pre-treatment liver biopsy. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 158 |
| Study Start Date: | November 2009 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Other: 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)
Other Names:
|
| Experimental: Diamel |
Dietary Supplement: Diamel
Diamel, a nutritional supplement, 2 oral pills (660 mg), every 8 hours, daily, during 52 weeks
Other Name: Dietary supplement
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00820651
Locations
| Cuba | |
| National Institute of Gastroenterology | |
| Vedado, Havana, Cuba, 10400 | |
Sponsors and Collaborators
Catalysis SL
Investigators
| Principal Investigator: | Eduardo Vilar Gomez, Ph.D | National Institute of Gastroenterology |
More Information
Additional Information:
Publications:
Hernandez Yero JA, Vargas Gonzalez D. Utilidad de Diamel en pacientes con diabetes mellitus tipo 2 en tratamiento combinado con glibenclamida. Avances en Diabetología 23(1):284-290, 2007
| Responsible Party: | Catalysis SL |
| ClinicalTrials.gov Identifier: | NCT00820651 History of Changes |
| Other Study ID Numbers: | DIAMEL_NASH-09 |
| Study First Received: | January 9, 2009 |
| Last Updated: | April 25, 2012 |
| Health Authority: | Cuba: National Coordinating Center of Clinical Trials (CENCEC) |
Keywords provided by Catalysis SL:
|
Nonalcoholic steatohepatitis Insulinresistance Diet and exercise |
Nutritional supplement Nonalcoholic fatty liver disease Lifestyle modifications |
Additional relevant MeSH terms:
|
Insulin Resistance Fatty Liver Hyperinsulinism Glucose Metabolism Disorders |
Metabolic Diseases Liver Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013