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Double-blind randomized placebo-controlled clinical trial of omega 3 fatty acids for the treatment of diabetic patients with nonalcoholic steatohepatitis.
J Clin Gastroenterol 2015; 49(2):137-44JC

Abstract

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.

Authors+Show Affiliations

Departments of *Gastroenterology †Pathobiology ∥Pathology, Cleveland Clinic Departments of ¶Gastroenterology ‡Family Medicine §Pathology, MetroHealth Medical Center, Cleveland, OH.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24583757

Citation

Dasarathy, Srinivasan, et al. "Double-blind Randomized Placebo-controlled Clinical Trial of Omega 3 Fatty Acids for the Treatment of Diabetic Patients With Nonalcoholic Steatohepatitis." Journal of Clinical Gastroenterology, vol. 49, no. 2, 2015, pp. 137-44.
Dasarathy S, Dasarathy J, Khiyami A, et al. Double-blind randomized placebo-controlled clinical trial of omega 3 fatty acids for the treatment of diabetic patients with nonalcoholic steatohepatitis. J Clin Gastroenterol. 2015;49(2):137-44.
Dasarathy, S., Dasarathy, J., Khiyami, A., Yerian, L., Hawkins, C., Sargent, R., & McCullough, A. J. (2015). Double-blind randomized placebo-controlled clinical trial of omega 3 fatty acids for the treatment of diabetic patients with nonalcoholic steatohepatitis. Journal of Clinical Gastroenterology, 49(2), pp. 137-44. doi:10.1097/MCG.0000000000000099.
Dasarathy S, et al. Double-blind Randomized Placebo-controlled Clinical Trial of Omega 3 Fatty Acids for the Treatment of Diabetic Patients With Nonalcoholic Steatohepatitis. J Clin Gastroenterol. 2015;49(2):137-44. PubMed PMID: 24583757.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Double-blind randomized placebo-controlled clinical trial of omega 3 fatty acids for the treatment of diabetic patients with nonalcoholic steatohepatitis. AU - Dasarathy,Srinivasan, AU - Dasarathy,Jaividhya, AU - Khiyami,Amer, AU - Yerian,Lisa, AU - Hawkins,Carol, AU - Sargent,Ruth, AU - McCullough,Arthur J, PY - 2014/3/4/entrez PY - 2014/3/4/pubmed PY - 2015/7/24/medline SP - 137 EP - 44 JF - Journal of clinical gastroenterology JO - J. Clin. Gastroenterol. VL - 49 IS - 2 N2 - 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. SN - 1539-2031 UR - https://www.unboundmedicine.com/medline/citation/24583757/Double_blind_randomized_placebo_controlled_clinical_trial_of_omega_3_fatty_acids_for_the_treatment_of_diabetic_patients_with_nonalcoholic_steatohepatitis_ L2 - http://dx.doi.org/10.1097/MCG.0000000000000099 DB - PRIME DP - Unbound Medicine ER -