Polyunsaturated Fatty Acids (PUFA) in Diabetic Fatty Liver
Ключови думи
Резюме
Описание
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.
Дати
| Последна проверка: | 09/30/2017 |
| Първо изпратено: | 05/04/2006 |
| Очаквано записване подадено: | 05/04/2006 |
| Първо публикувано: | 05/08/2006 |
| Изпратена последна актуализация: | 02/21/2018 |
| Последна актуализация публикувана: | 02/22/2018 |
| Дата на първите подадени резултати: | 08/23/2017 |
| Дата на първите подадени резултати от QC: | 02/21/2018 |
| Дата на първите публикувани резултати: | 02/22/2018 |
| Действителна начална дата на проучването: | 03/31/2006 |
| Приблизителна дата на първично завършване: | 11/30/2011 |
| Очаквана дата на завършване на проучването: | 11/30/2011 |
Състояние или заболяване
Интервенция / лечение
Drug: Polyunsaturated fatty acid (Opti-EPA)
Drug: Placebo
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| 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 |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | All |
| Приема здрави доброволци | Да |
| Критерии | 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. |
Резултат
Първични изходни мерки
1. Number of Participants With Improvement of >= 2 Points in NAFLD Activity Score (NAS) [48 weeks]
Вторични изходни мерки
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]
