Clinical trial NCT02427087: 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
Overall status: COMPLETED
Phase: NA
Conditions: Fatty Liver
Keywords: Nonalcoholic fatty liver
Physical activity
NAFLD
Anthropometry
Body Composition
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2015-04-27
Enrollment: 40
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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%.

Primary outcomes:
measure: Efficacy in reduce inflammatory component of NASH for transient elastography liver
timeFrame: 6 months
Secondary outcomes:
measure: Inflammatory systemic profile
timeFrame: 6 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo School of Medicine
Study officials:
affiliation: University of Sao Paulo, School of Medicine
name: CLAUDIA PM MD OLIVEIRA, PhD
role: PRINCIPAL_INVESTIGATOR
References: