Double-blind randomized placebo-controlled clinical trial of omega 3 fatty acids for the treatment of diabetic patients with nonalcoholic steatohepatitis
Dasarathy S, Dasarathy J, Khiyami A, Yerian L, Hawkins C, Sargent R, McCullough AJ
Journal of clinical gastroenterology · 126 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Universidad u hospital
- Cleveland Clinic
- Gobierno
- U.S. Public Health Service
- Gobierno
- National Institute of Diabetes and Digestive and Kidney Diseases
- Gobierno
- National Center for Advancing Translational Sciences
- Gobierno
- NIDDK NIH HHS
- Gobierno
- NCATS NIH HHS
- Gobierno
- PHS HHS
- Subvenciones
- National Center for Advancing Translational Sciences (UL1-TR-000439); National Institute of Diabetes and Digestive and Kidney Diseases (DK83414); National Institute of Diabetes and Digestive and Kidney Diseases (U01 DK061732); National Institute of Diabetes and Digestive and Kidney Diseases (R01-DK-083414); U.S. Public Health Service (U01061732)
Según 7 financiadores declarados.
Publicación
- Publicado
- 2014-02-28 · J Clin Gastroenterol · vol. 49 · número 2 · págs. 137–144
- Editorial
- Lippincott Williams & Wilkins
- Citado
- 163 citas · más que el 99% de estudios similares · 13.0× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 63 trabajos
- Acceso
- Acceso abierto (copia en repositorio)
- Áreas de investigación
- Liver Disease Diagnosis and Treatment · Fatty Acid Research and Health · Alcohol Consumption and Health Effects
- Palabras clave
- nonalcoholic steatohepatitis, diabetes mellitus, omega-3 fatty acids, polyunsaturated fatty acids, eicosapentaenoic acid, docosahexaenoic acid, insulin resistance, hepatic steatosis, lobular inflammation, liver histopathology, dietary supplementation
- MeSH
- humans, diabetes mellitus, insulin resistance, docosahexaenoic acids, eicosapentaenoic acid, capsules, biopsy, treatment outcome, drug therapy, combination, administration, oral, prospective studies, feasibility studies, pilot projects, double-blind method, time factors, adult, middle aged, ohio, female, male, intention to treat analysis, non-alcoholic fatty liver disease, biomarkers
7 autores
- Srinivasan Dasarathy🇺🇸 · autor de correspondenciaCleveland Clinic; MetroHealth Medical Center
- Jaividhya Dasarathy
- Amer Khiyami🇺🇸MetroHealth Medical Center
- Lisa M. Yerian🇺🇸Cleveland Clinic
- Carol Hawkins
- Ruth Sargent · autor de correspondencia
- Arthur J. McCullough · autor de correspondencia
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Nonalcoholic steatohepatitis (NASH) is common and severe in patients with diabetes mellitus. Although, there are no effective treatments for NASH in diabetic patients, preliminary reports suggest that polyunsaturated fatty acids (PUFA) may be beneficial in these patients.
Aim
A prospective, randomized, double-blind placebo-controlled study (NCT 00323414) was performed in NASH patients with diabetes. Clinicaltrials.gov (NCT 00323414).
Subjects and methods
A total of 37 patients (50.6 ± 9.8 y) with well-controlled diabetes (HbA1C<8.5%) were randomized to receive either PUFA containing eicosapentaenoic acid (2160 mg) and docosahexaenoic acid (1440 mg) daily or an isocaloric, identical placebo containing corn oil for 48 weeks under CONSORT guidelines. Clinical, demographics, biochemical laboratory tests, body composition using DEXA, and liver biopsy were performed at randomization and at the end of treatment. Liver biopsy was scored by the NASH CRN criteria. An intention-to-treat analysis was performed.
Results
At inclusion, sex, age, body weight, biochemical tests, glucose control, and liver histology were similar in the 2 treatment groups. There was no change in liver enzymes, body weight, or body composition during the study in either group. At the end of the treatment, hepatic steatosis and the activity score improved (P<0.05) and lobular inflammation worsened (P<0.001) with placebo but was unchanged with PUFA. At the end of the treatment, insulin resistance (serum glucose and HOMA) worsened with PUFA but not placebo.
Conclusions
PUFA provided no benefit over placebo in NASH patients with diabetes. The effects of PUFA on histology and insulin resistance were inferior to placebo. These data provide no support for PUFA supplements in NASH.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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