LB043 - A PRELIMINARY ANALYSIS OF THE EVOLUTION OF TRANSIENT LIVER ELASTOGRAPHY PARAMETERS IN PARTICIPANTS WITH STEATOSIS: A SUB-ANALYSIS FROM THE OLTRAD STUDY
LB043
A PRELIMINARY ANALYSIS OF THE EVOLUTION OF TRANSIENT LIVER ELASTOGRAPHY PARAMETERS IN PARTICIPANTS WITH STEATOSIS: A SUB-ANALYSIS FROM THE OLTRAD STUDY
A. J. MARTINEZ ORTEGA1,*, A. Jiménez Sánchez1, A. Piñar-Gutiérrez1, M. D. C. Roque-Cuéllar1, S. García-Rey1, P. J. Remón-Ruiz1, J. L. Pereira-Cunill1, I. González-Navarro1, M. Á. Mangas-Cruz1, J. Sánchez-Perona2, J. M. Castellanos-Orozco3, P. P. García-Luna1
1Unidad de Endocrinología y Nutrición, Hospital Universitario Virgen del Rocío (Servicio Andaluz de Salud), 2Universidad Pablo de Olavide, 3Instituto de la Grasa, Sevilla, Spain
Rationale: - Oleanolic acid is a triterpenoid extracted from the leaf of Olea europaea.
- The prevalence of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is high amongst patients with type 2 diabetes (DM2) and represents a major clinical concern for diabetologists and hepatologists due to the limited therapeutic options for this condition.
- In the randomized, placebo-controlled, double-blind clinical trial OLTRAD, the possible effect of this nutraceutical on different metabolic parameters in ambulatory patients with DM2 has been analyzed. In this communication a subanalysis of transient liver elastography (FibroScan) in the study sample is presented.
Methods: - Olive oil consumption was randomized to placebo (green group) or with oleanolic acid added at 600 mg/kg (red group), both at 55 mL/day.
- Inclusion criteria: diagnosis of DM2, chronic treatment with of metformin ≥850 mg/day for ≥3 months, glycosylated hemoglobin (HbA1c) <9 ± 0.5 % at the time of inclusion, and performing a specific informed consent for the study.
- The following tests were carried out both at baseline and at 12 months of intervention:
1. Fasting FibroScan with Controlled Attenuation Parameter (CAP) and liver stiffness.
2. Alcohol consumption questionnaire.
3. Serum biochemistry with HbA1c and liver function parameters.
4. Use of antidiabetic drugs that could influence steatosis.
- Statistical analysis: numerical variables were synthesized as median (IQR), and frequencies expressed as count (%). Statistical inference in numerical variables was performed using t-test if data were normal or Wilcoxon test in the absence of normality, using a version for paired data when comparing FibroScan parameters. Proportions were analyzed with X2. Only participants that satisfactorily completed a baseline and 12-month follow-up FibroScan exploration, while having steatosis at the baseline measurement (defined as CAP >248 dB/m) were included for statistical analysis.
Results: - A total of n = 57 participants were included. No differences were found in green vs red groups in terms of biochemical variables, ethanol consumption (2/30 (6.7%) vs 3/27 (11%); p= 0.7), aRGLP1 use (15/30 (50%) vs 13/27 (48%); p = 0.9) and iSGLT2 use (16/30 (53%) vs 10/27 (37%); p= 0.2). Despite randomization, the red group had a higher dose of metformin, 2,000 (225) vs 1,700 (725) mg/day (p = 0.006).
- CAP followed a normal distribution (p = 0.145). The evolution from visit 0 to 12 months was 301.7 (42.5) vs. 276.7 (55.3) dB/m in the green group (p = 0.009), and 304.6 (32.4) vs. 283.5 (60.0) dB/m in the red group (p = 0.043). We did not find differences between groups in initial (p = 0.775) or final (p = 0.660) t-test visits.
- Hepatic stiffness followed a non-normal distribution (p = 0.006). The evolution from visit 0 to 12 months was 5.65 (1.8) vs. 5.4 (1.7) kPa in the green group (p = 0.030), and 4.75 (1.85) vs. 4.35 (1.72) kPa in the red group (p = 0.024). We found no differences between groups at the initial (p = 0.366) or final visit (p = 0.254).
Conclusion: - The consumption of olive oil enriched with oleanolic acid for 12 months in people with DM2 treated with metformin improved FibroScan parameters, although no differences with respect to placebo were found.
Disclosure of Interest: None declared