Fatty LiverNCT02427087
Sedentary Postmenopausal Women With Nonalcoholic Fatty Liver Disease (NAFLD) Submitted to Physical Activity
A study testing Continuous Aerobic Training twice and Healthy Diet in people with Fatty Liver, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 35 to 75 years, women only
- Conditions the study is for
- Fatty Liver
- What is being tested?
- Continuous Aerobic Training twice and Healthy Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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%.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of Sao Paulo School of Medicine
São Paulo, São Paulo, 01246903
About this study
Official title: Anthropometric Evaluation and Body Composition in Sedentary Postmenopausal Women With Nonalcoholic Fatty Liver Disease (NAFLD) Submitted to Physical Activity
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.
Read the 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
- Being tested
- Continuous Aerobic Training twice, Healthy Diet
- Keywords
- Nonalcoholic fatty liver, Physical activity, NAFLD, Anthropometry, Body Composition
- Medical subject headings
- Fatty Liver, Non-alcoholic Fatty Liver Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Aerobic Training twiceBehavioural
Supervised aerobic exercise program of 60 min/2 days/week at 60-85% of heart rate reserve for 24 weeks and healthy diet
Healthy DietBehavioural
Diet group (21) Recommendation for healthy diet.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Aerobic training | Active comparator | 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. Receives: Behavioral: Continuous Aerobic Training twice; Behavioral: Healthy Diet |
| Healthy diet | Active comparator | Diet group (n=21 patients) only recommendation for healthy diet. Receives: Behavioral: Healthy Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study startJan 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Pinto Marques Oliveira, University of Sao Paulo General Hospital
- Investigators
- CLAUDIA PM MD OLIVEIRA, PhD, Principal investigator, University of Sao Paulo, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427087
- Sponsor's protocol ID
- 9022
- Status last verified
- Apr 2015
- First submitted
- 4 Mar 2015
- Last updated
- 27 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anthropometric Evaluation and Body Composition in Sedentary Postmenopausal Women With Nonalcoholic Fatty Liver Disease (NAFLD) Submitted to Physical Activity
- ClinicalTrials.gov ID
- NCT02427087
- Acronym / sponsor ID
- 9022
- Conditions
- Fatty Liver
- Keywords
- Nonalcoholic fatty liver, Physical activity, NAFLD, Anthropometry, Body Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 27 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Aerobic training | Active comparator | Behavioral: Continuous Aerobic Training twice, Behavioral: Healthy DietAerobic 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. |
| Healthy diet | Active comparator | Behavioral: Healthy DietDiet group (n=21 patients) only recommendation for healthy diet. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Aerobic Training twiceSupervised aerobic exercise program of 60 min/2 days/week at 60-85% of heart rate reserve for 24 weeks and healthy diet | Behavioural | Continuous Aerobic training |
| Healthy DietDiet group (21) Recommendation for healthy diet. | Behavioural | Continuous Aerobic training, Healthy diet |
Primary outcome
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]
1 secondary outcome
Inflammatory systemic profile
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CLAUDIA PM MD OLIVEIRA, PhD principal investigator
University of Sao Paulo, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Aerobic Training twice and Healthy Diet in people with Fatty Liver, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy in reduce inflammatory component of NASH for transient elastography liver (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2015.