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

Primary Purpose

Fatty Liver

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Continuous Aerobic Training twice
Healthy Diet
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatty Liver focused on measuring Nonalcoholic fatty liver, Physical activity, NAFLD, Anthropometry, Body Composition

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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%.

Sites / Locations

  • University of Sao Paulo School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Continuous Aerobic training

Healthy diet

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Efficacy in reduce inflammatory component of NASH for transient elastography liver
Determine the efficacy of the physical activity in reducing the systemic inflammatory component of NASH in patients with NAFLD for transient elastography liver, FibroScan (FS) [stiffness liver (SL) /CAP]

Secondary Outcome Measures

Inflammatory systemic profile
Measure tumoral factor TNFalfa, interleukin 6 (IL6), adiponectin, lipidic and laboratory tests aspartate aminotransferase (AST), alanine aminotransferase (ALT), Cholesterol, total triglycerides, glicemy, insulin.

Full Information

First Posted
March 4, 2015
Last Updated
April 24, 2015
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02427087
Brief Title
Sedentary Postmenopausal Women With Nonalcoholic Fatty Liver Disease (NAFLD) Submitted to Physical Activity
Official Title
Anthropometric Evaluation and Body Composition in Sedentary Postmenopausal Women With Nonalcoholic Fatty Liver Disease (NAFLD) Submitted to Physical Activity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatty Liver
Keywords
Nonalcoholic fatty liver, Physical activity, NAFLD, Anthropometry, Body Composition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous Aerobic training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Healthy diet
Arm Type
Active Comparator
Arm Description
Diet group (n=21 patients) only recommendation for healthy diet.
Intervention Type
Behavioral
Intervention Name(s)
Continuous Aerobic Training twice
Intervention Description
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
Intervention Name(s)
Healthy Diet
Intervention Description
Diet group (21) Recommendation for healthy diet.
Primary Outcome Measure Information:
Title
Efficacy in reduce inflammatory component of NASH for transient elastography liver
Description
Determine the efficacy of the physical activity in reducing the systemic inflammatory component of NASH in patients with NAFLD for transient elastography liver, FibroScan (FS) [stiffness liver (SL) /CAP]
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Inflammatory systemic profile
Description
Measure tumoral factor TNFalfa, interleukin 6 (IL6), adiponectin, lipidic and laboratory tests aspartate aminotransferase (AST), alanine aminotransferase (ALT), Cholesterol, total triglycerides, glicemy, insulin.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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%.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CLAUDIA PM MD OLIVEIRA, PhD
Organizational Affiliation
University of Sao Paulo, School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo School of Medicine
City
Sao Paulo
ZIP/Postal Code
01246903
Country
Brazil

12. IPD Sharing Statement

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

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