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

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ClinicalTrials.gov Identifier: NCT02427087
Recruitment Status : Completed
First Posted : April 27, 2015
Last Update Posted : April 27, 2015
Sponsor:
Information provided by (Responsible Party):
Claudia Pinto Marques Oliveira, University of Sao Paulo General Hospital

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.


Condition or disease Intervention/treatment Phase
Fatty Liver Behavioral: Continuous Aerobic Training twice Behavioral: Healthy Diet Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Anthropometric Evaluation and Body Composition in Sedentary Postmenopausal Women With Nonalcoholic Fatty Liver Disease (NAFLD) Submitted to Physical Activity
Study Start Date : January 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014


Arm Intervention/treatment
Active Comparator: 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.
Behavioral: 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

Behavioral: Healthy Diet
Diet group (21) Recommendation for healthy diet.

Active Comparator: Healthy diet
Diet group (n=21 patients) only recommendation for healthy diet.
Behavioral: Healthy Diet
Diet group (21) Recommendation for healthy diet.




Primary Outcome Measures :
  1. Efficacy in reduce inflammatory component of NASH for transient elastography liver [ Time Frame: 6 months ]
    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 :
  1. Inflammatory systemic profile [ Time Frame: 6 months ]
    Measure tumoral factor TNFalfa, interleukin 6 (IL6), adiponectin, lipidic and laboratory tests aspartate aminotransferase (AST), alanine aminotransferase (ALT), Cholesterol, total triglycerides, glicemy, insulin.



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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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%.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427087


Locations
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Brazil
University of Sao Paulo School of Medicine
Sao Paulo, Brazil, 01246903
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: CLAUDIA PM MD OLIVEIRA, PhD University of Sao Paulo, School of Medicine

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Responsible Party: Claudia Pinto Marques Oliveira, PhD, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02427087     History of Changes
Other Study ID Numbers: 9022
First Posted: April 27, 2015    Key Record Dates
Last Update Posted: April 27, 2015
Last Verified: April 2015

Keywords provided by Claudia Pinto Marques Oliveira, University of Sao Paulo General Hospital:
Nonalcoholic fatty liver
Physical activity
NAFLD
Anthropometry
Body Composition

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases