Clinical Trials Logo

Clinical Trial Summary

Non-alcoholic fatty liver disease (NAFLD) is a highly prevalent disorder which is directly linked to lifestyle patterns and is associated with poor quality of life, increased fatigue and psychological distress. The aim of the current study is to evaluate quality of life, fatigue and psychological functioning in NAFLD patients and assess the impact of systematic counseling on patients' psychosocial functioning.


Clinical Trial Description

Introduction: The term non-alcoholic fatty liver disease (NAFLD) encompasses a spectrum of disorders ranging from simple steatosis to steatohepatitis, in the absence of other known causes of liver steatosis. NAFLD is a highly prevalent disorder which is directly linked to patients' lifestyle and is accompanied by severe co-morbidities. Although there is a wealth of studies on NAFLD's pathogenesis, natural course and treatment, few investigations have focused on patients' quality of life (QoL) and even fewer have evaluated the impact of therapeutic interventions on patients' quality of life and psychosocial functioning. In this context, there is a significant literature gap, given that modern research and clinical practice should aim at meeting patients' subjective physical and psychosocial needs and improving their overall quality of living.

Aim-Methods: In this context, the aim of the present study is to assess the effect of systematic counseling on NAFLD patients' quality of life, psychological distress, fatigue and lifestyle habits.

The current study will be conducted at the Gastroenterology Department of the University Hospital of Patras with the collaboration of the Department of Psychiatry. NAFLD patients will be invited to enrol to the study after being thoroughly informed about its aim and methods. Eligible patients will be assessed at baseline and then will be randomized to receive either systematic counseling based on the principles of Motivational Interviewing or care as usual. All participants will be re-evaluated at 6 months after study initiation. In addition, all patients will be submitted to laboratory tests including complete blood count, serum albumin, hemoglobin, gamma-globulin, ALT, AST, γGT, ALP, bilirubin, PT, INR, urea, creatinine, total cholesterol, LDL, HDL, triglycerides both at baseline and at study completion ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03613480
Study type Interventional
Source University Hospital of Patras
Contact Christos Triantos, PhD
Phone 00306972894651
Email chtriantos@hotmail.com
Status Recruiting
Phase N/A
Start date September 1, 2018
Completion date March 1, 2020

See also
  Status Clinical Trial Phase
Completed NCT03256526 - 6-week Safety and PD Study in Adults With NAFLD Phase 2
Completed NCT03060694 - Screening Diabetes Patients for NAFLD With Controlled Attenuation Parameter and Liver Stiffness Measurements
Completed NCT02526732 - Hepatic Inflammation and Physical Performance in Patients With NASH N/A
Recruiting NCT01988441 - The Influence of Autophagy on Fatty Liver
Recruiting NCT01680003 - Hepar-P Study to Evaluate the Safety and Efficacy of a Standardised Extract of Phyllanthus Niruri for the Treatment of Non-alcoholic Fatty Liver Disease Phase 2
Completed NCT01712711 - Helicobacter Pylori Eradication in Diabetic Subjects With Non-alcoholic Fatty Liver Disease Phase 2
Recruiting NCT00941642 - Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease Phase 4
Active, not recruiting NCT00714129 - De Novo Lipogenesis, Lipid and Carbohydrate Metabolism in Non-alcoholic Fatty Liver Disease N/A
Completed NCT01257685 - Selenoprotein P and Non-alcoholic Fatty Liver Disease N/A
Completed NCT00230113 - Effect of Omega-3 PUFA Supplementation in NAFLD Patients Phase 2
Completed NCT00230087 - Iron Depletion Therapy for Type 2 DM and NAFLD Phase 2
Completed NCT03614039 - Effect of Probiotic and Smectite Gel on NAFLD N/A
Completed NCT02650830 - Seum Bile Acid Profile in Type 2 Diabetes and Association Between Bile Cid Profile and Adipokine or Oxidative Stress
Completed NCT03625362 - Hydrogen-rich Water for Non-alchoholic Fatty Liver Disease N/A
Completed NCT03942822 - Chia Supplementation and Non Alcoholic Fatty Liver Disease N/A
Completed NCT01371396 - Effect of Dietary Macronutrient Composition N/A
Completed NCT01431521 - Study of Changes in Hepatic Fat Following Administration of MK-4074 and Pioglitazone Hydrochloride (MK-4074-008) Phase 1
Recruiting NCT02951546 - Study on Metabolic Flexibility and Gut Microbiota Composition in Obese Subjects With NAFLD, Taking Into Account PNPLA3 and TM6SF2 Polymorphisms. Effects of Nutritional Intervention Combined to Exercise N/A
Completed NCT02974374 - Single Dose of PF-06835919 Escalation Study in Healthy Adult Subjects Phase 1
Recruiting NCT02579408 - Quantifying Steatosis in Liver Transplant Donors