Polyunsaturated Fatty Acids (PUFA) in Diabetic Fatty Liver
关键词
抽象
描述
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.
日期
| 最后验证: | 09/30/2017 |
| 首次提交: | 05/04/2006 |
| 提交的预估入学人数: | 05/04/2006 |
| 首次发布: | 05/08/2006 |
| 上次提交的更新: | 02/21/2018 |
| 最近更新发布: | 02/22/2018 |
| 首次提交结果的日期: | 08/23/2017 |
| 首次提交质量检查结果的日期: | 02/21/2018 |
| 首次发布结果的日期: | 02/22/2018 |
| 实际学习开始日期: | 03/31/2006 |
| 预计主要完成日期: | 11/30/2011 |
| 预计完成日期: | 11/30/2011 |
状况或疾病
干预/治疗
Drug: Polyunsaturated fatty acid (Opti-EPA)
Drug: Placebo
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| 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 |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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. |
结果
主要结果指标
1. Number of Participants With Improvement of >= 2 Points in NAFLD Activity Score (NAS) [48 weeks]
次要成果指标
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]
