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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00820651
Other study ID # DIAMEL_NASH-09
Secondary ID
Status Completed
Phase Phase 3
First received January 9, 2009
Last updated April 25, 2012
Start date November 2009
Est. completion date April 2012

Study information

Verified date April 2012
Source Catalysis SL
Contact n/a
Is FDA regulated No
Health authority Cuba: National Coordinating Center of Clinical Trials (CENCEC)
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 158
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 a-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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

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

Locations

Country Name City State
Cuba National Institute of Gastroenterology Vedado Havana

Sponsors (1)

Lead Sponsor Collaborator
Catalysis SL

Country where clinical trial is conducted

Cuba, 

References & Publications (1)

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
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