Fatty Liver Clinical Trial
Official title:
Randomized Controlled Trial of Omega-3 Fatty Acids in the Treatment of Non-Alcoholic Steatohepatitis in Patients With Type 2 Diabetes Mellitus
Verified date | October 2017 |
Source | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Non-alcoholic steatohepatitis (NASH), the most severe form of liver injury in the spectrum of
non-alcoholic fatty liver disease (NAFLD), has emerged as the major cause of chronic liver
disease in developed countries. Among adults in the United States, the prevalence is between
5.7% and 17%. These rates are expected to increase concurrent with the epidemics of obesity
and type 2 diabetes mellitus, which are the major risk factors for NAFLD and NASH. In
addition to its high prevalence, NASH is also a progressive fibrotic disease that advances to
cirrhosis and liver related death in 20% and 12% of patients, respectively. Among NASH
patients with cirrhosis, 40% have liver related death. Diabetics are particularly prone to
experience these poor outcomes. No therapy has been proven effective for patients with NASH.
The purpose of this study is to find out whether treatment with polyunsaturated fatty acids
(eicosapentaenoic acid [EPA] combined with docosahexaenoic acid [DHA] called Opti-EPA)
improves NASH compared to treatment with placebo pills. The placebo pills will contain corn
oil and will be contained in a capsule, but have no medical effect on the body. The
investigators will determine improvement in NASH from microscopic changes in the subject's
liver tissue during 48 weeks of treatment. This means that the subject will need to have a
liver biopsy before and after the treatment.
Omega-3 fatty acids are a form of polyunsaturated fats, one of the four basic types of fat
that the body gets from food. (Cholesterol, saturated fat, and monounsaturated fat are the
others.) One's body does not make this type of fat; it comes from food sources. These fats
are found in foods like cold water fish (tuna, salmon, and mackerel), and vegetable products
like flaxseed oil and walnuts.
Research shows that polyunsaturated fats are good for people. Studies have shown that it is
good for heart health by playing a role in keeping blood cholesterol levels low, keeping
irregular heart rhythms stable, and reducing blood pressure.
The drug being studied, Opti-EPA, is a nutritional supplement. They do not have to be
reviewed by the Food and Drug Administration (FDA) like medicines do. Opti-EPA is considered
experimental in this study. This means that the United States Food and Drug Administration
(FDA) has not approved it for use in people with nonalcoholic fatty liver disease.
Status | Completed |
Enrollment | 37 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult patients (age >18 years) - Have type 2 diabetes mellitus with good control of blood sugar (hemoglobin A1c [HbA1c] <7.5%) and will have been on a stable regimen of anti-diabetic agents for more than 4 months. - NASH established on liver biopsy done within 6 months prior to inclusion in the study as determined by established histologic criteria Exclusion Criteria: - Cirrhosis of the liver - End stage target organ damage in diabetes mellitus: advanced renal failure (serum creatinine > 2.0 mg/dl) with or without dialysis, severe neuropathy, or advanced peripheral vascular disease. - Any organ dysfunction with anticipated life expectancy of less than 2 years - Co-existent etiologies for liver disease - Significant alcohol consumption, defined as more than 30 g per day in men and more than 20 g per day in women. |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | MetroHealth Medical Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Younossi ZM, Gramlich T, Matteoni CA, Boparai N, McCullough AJ. Nonalcoholic fatty liver disease in patients with type 2 diabetes. Clin Gastroenterol Hepatol. 2004 Mar;2(3):262-5. Erratum in: Clin Gastroenterol Hepatol. 2004 Jun;2(6):522. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Improvement of >= 2 Points in NAFLD Activity Score (NAS) | The non-alcoholic fatty liver disease (NAFLD) activity score (NAS) is a score based on the liver biopsy. It represents the sum of scores for steatosis, lobular inflammation, and ballooning, and ranges from 0-8, with high scores indicating more activity. | 48 weeks | |
Secondary | Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Values | Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) measures insulin resistance, calculated by fasting insulin (µU/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405). A higher score indicates higher insulin resistance. | 48 weeks | |
Secondary | Aspartate Amino Transferase (AST) Levels | Aspartate amino transferase (IU/dL) at 48 weeks | 48 weeks | |
Secondary | Alanine Amino Transferase (ALT) Levels | Alanine amino transferase (IU/dL) ay 48 weeks | 48 weeks | |
Secondary | Blood Glucose Levels | Fasting blood glucose | 48 weeks | |
Secondary | HbA1C Levels | Hemoglobin A1c | 48 weeks |
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