Polyunsaturated Fatty Acids (PUFA) in Diabetic Fatty Liver
Kľúčové slová
Abstrakt
Popis
Although there is no proven effective treatment of NASH, dietary supplementation with long chain omega-3 polyunsaturated fatty acids (PUFA's) may be beneficial. This suggestion is based on three previously reported observations: first, patients with NASH consume less PUFAs and more saturated fats than subjects without NASH. Second, PUFAs are beneficial in patients with hypertension and hypertriglyceridemia. Third, PUFAs decrease lipid peroxidation and ameliorate hepatic steatosis in animal models of NAFLD.
We therefore hypothesize that the administration of these PUFAs, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) will reduce hepatic fat content, inflammation and hepatic injury in patients with type 2 diabetes mellitus who have NASH.
Aims
To determine in patients with type 2 diabetes mellitus who have NASH if dietary supplementation with purified omega-3 fatty acids (EPA and DHA) will:
1. Decrease the histologic severity of NASH.
2. Alter the expression of genes important in the pathways of hepatic lipid synthesis and oxidation.
Study design:
Patients who meet the inclusion criteria will be randomized to receive omega-3 fatty acids or placebo. Stratified randomization will be done based on the NASH Clinical Research Network pathology score of 5.
Termíny
| Naposledy overené: | 09/30/2017 |
| Prvý príspevok: | 05/04/2006 |
| Odhadovaná registrácia bola odoslaná: | 05/04/2006 |
| Prvý príspevok: | 05/08/2006 |
| Posledná aktualizácia bola odoslaná: | 02/21/2018 |
| Posledná aktualizácia bola zverejnená: | 02/22/2018 |
| Dátum prvých predložených výsledkov: | 08/23/2017 |
| Dátum prvých predložených výsledkov kontroly kvality: | 02/21/2018 |
| Dátum prvých zverejnených výsledkov: | 02/22/2018 |
| Aktuálny dátum začatia štúdie: | 03/31/2006 |
| Odhadovaný dátum dokončenia primárneho okruhu: | 11/30/2011 |
| Odhadovaný dátum dokončenia štúdie: | 11/30/2011 |
Stav alebo choroba
Intervencia / liečba
Drug: Polyunsaturated fatty acid (Opti-EPA)
Drug: Placebo
Fáza
Skupiny zbraní
| Arm | Intervencia / liečba |
|---|---|
| Active Comparator: Polyunsaturated fatty acid (Opti-EPA) Polyunsaturated fatty acid will consist of purified EPA:DHA (360 mg EPA and 240 mg DHA) 6 gelcaps-3 capsules by mouth 2x per day x 48 weeks | Drug: Polyunsaturated fatty acid (Opti-EPA) Active experimental arm to patients with diabetes mellitus and non alcoholic steatohepatitis: Eicosapentaenoic acid (EPA):Docosahexaenoic acid (DHA)[360 mg EPA and 240 DHA in each capsule] 6 capsules-3 capsules by mouth 2 x per day x 48 weeks |
| Placebo Comparator: Placebo Gelcaps containing corn oil as placebo 6 capsules 3 capsules by mouth 2 x per day for 48 weeks | Drug: Placebo Placebo gelcaps containing corn oil identical to the PUFA gelcaps 6 capsules-3 capsules by mouth 2x per day x 48 weeks |
Kritériá oprávnenosti
| Vek vhodný na štúdium | 18 Years To 18 Years |
| Pohlavia vhodné na štúdium | All |
| Prijíma zdravých dobrovoľníkov | Áno |
| Kritériá | 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. |
Výsledok
Primárne výstupné opatrenia
1. Number of Participants With Improvement of >= 2 Points in NAFLD Activity Score (NAS) [48 weeks]
Opatrenia sekundárnych výsledkov
1. Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Values [48 weeks]
2. Aspartate Amino Transferase (AST) Levels [48 weeks]
3. Alanine Amino Transferase (ALT) Levels [48 weeks]
4. Blood Glucose Levels [48 weeks]
5. HbA1C Levels [48 weeks]
