Sedentary Postmenopausal Women With Nonalcoholic Fatty Liver Disease (NAFLD) Submitted to Physical Activity

NCT ID: NCT02427087

Last Updated: 2015-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-12-31

Brief Summary

Were included 40 patients with NAFLD followed at the Ambulatory of Non-alcoholic Fatty Liver Disease , Discipline of Clinical Gastroenterology, Clinic Hospital of the Medical School of the University of Sao Paulo (HC-FMUSP). Were included adults women of any race, aged 35 to 75 years, diagnosed with NAFLD and were followed for a period of six months. All patients underwent anthropometric and body composition, as well as analysis of clinical, laboratory before and after 6 months of exercise training protocol established.

The hypothesis of our research is that aerobic activity had a favorable impact on NAFLD. It is expected that the intervention of physical activity causes a decrease or no weight, decreased levels of aminotransferases, decreased insulin resistance assessed by homeostasis model assessment (HOMA) index and consequently decrease or reversal of hepatic steatosis.

Detailed Description

The Nonalcoholic fatty liver disease (NAFLD) is the most common form of liver diseases, affecting approximately 20-30% of the adult population and is more common in obese individuals (70-80%). The main risk factors associated with the disease are the components of the Metabolic syndrome. To date, there is no specific pharmacological treatment for NAFLD and changes in lifestyle with weight reduction and exercise are always recommended. Few data exist on the impact of physical activity and optimal nutritional strategy for the treatment of NAFLD. Seen the need to elucidate the impact of physical activity and the search for an ideal nutritional strategy in the treatment of NAFLD, the investigators proposed a randomized controlled trial evaluating the effects of a hypocaloric high-protein diet and aerobic exercise associated with this diet on metabolic and anthropometric parameters in sedentary postmenopausal women. 40 sedentary postmenopausal women with NAFLD who had liver biopsy for a period equal to or less than 2 (two) years were included. These patients were randomized into 2 groups: TRAINING group (19): aerobic training with hypocaloric high-protein diet and DIET group (21): only hypocaloric high-protein diet, and followed for a period of six months.

Laboratorial Assays (baseline and end of the protocol)

• AST, ALT, FA, GGT, albumine, Fe, fasting glucose, insulin, Total cholesterol, HDL, LDL, Triglycerides;
• TNFalfa, IL6, and adiponectin.

Anthropometrical Evaluation (baseline and end of the protocol)

• BMI, waist circumference, percent body fat, body fat mass, lean body mass

Conditions

Fatty Liver

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Continuous Aerobic training

Aerobic training continuous (n=19 patients) carry a protocol continuous aerobic training twice a week for 24 weeks and the session will last 60 minutes/2 days/week with recommendation for healthy diet.

Group Type: ACTIVE_COMPARATOR

Continuous Aerobic Training twice

Intervention Type: BEHAVIORAL

Supervised aerobic exercise program of 60 min/2 days/week at 60-85% of heart rate reserve for 24 weeks and healthy diet

Healthy Diet

Intervention Type: BEHAVIORAL

Diet group (21) Recommendation for healthy diet.

Healthy diet

Diet group (n=21 patients) only recommendation for healthy diet.

Group Type: ACTIVE_COMPARATOR

Healthy Diet

Intervention Type: BEHAVIORAL

Diet group (21) Recommendation for healthy diet.

Interventions

Continuous Aerobic Training twice

Supervised aerobic exercise program of 60 min/2 days/week at 60-85% of heart rate reserve for 24 weeks and healthy diet

Intervention Type: BEHAVIORAL

Healthy Diet

Diet group (21) Recommendation for healthy diet.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 35-75 years of age, Female
• Biopsy-liver until 24 months previous that prove NAFLD or NASH
• Patients who agree to participate in the study and all signed informed consent.

Exclusion Criteria

• Presence of alcoholism <20g (women) of ethanol/day, drugs, schistosomiasis, hepatitis B or C and other chronic liver diseases cause determined
• Without medical clearance for physical activity
• Without availability to attend appointments and physical activities 2x/week
• Significant change in dietary habits and/or exercise in the last 3 months that resulted in weight loss > 5%.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Claudia Pinto Marques Oliveira

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

CLAUDIA PM MD OLIVEIRA, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo, School of Medicine

Locations

University of Sao Paulo School of Medicine

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

9022

Identifier Type: -

Identifier Source: org_study_id