Non-Alcoholic Fatty Liver DiseaseNCT06717828
The Effects of Tai Chi on Metabolic Dysfunction-associated Fatty Liver Disease in Middle-Aged and Older Adults
A study testing Tai Chi Exercise and Regular Exercise in people with Non-Alcoholic Fatty Liver Disease, run by Fujian Provincial Hospital at 1 site in China.
Trial summary
Background: Metabolic dysfunction-associated fatty liver disease (MAFLD) is a liver condition primarily driven by metabolic dysfunctions that may progress to hepatitis, cirrhosis, and hepatocellular carcinoma. It is also implicated in the development of other metabolic dysfunction-related diseases. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Tai Chi Exercise and Regular Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40 and 75 years;
- Liver fat content measured by mDixon QUANT is ≥5%;
- Diagnosis of metabolic associated fatty liver disease;
- Overweight/obesity (BMI ≥ 24 kg/m²);
- Signed written informed consent.
Who cannot join
- Excessive alcohol consumption (definition: in the past 6 months, males have consumed more than 140g of alcohol per week, and females have consumed more than 70g);
- Fatty liver due to other causes: such as alcoholic fatty liver, acute and chronic viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, etc.;
- Severe cardiovascular diseases, including myocardial infarction within the past 6 months;
- Heart failure (NYHA classification: III - IV);
- Biliary diseases: such as obstructive biliary diseases;
- Other diseases affecting glucose and lipid metabolism: diabetes, hyperthyroidism, hypothyroidism, Cushing's syndrome, etc.;
Show all 12Show fewer
- Poorly controlled blood pressure: SBP ≥ 180 mmHg, DBP ≥ 100 mmHg;
- Chronic kidney disease or severe renal impairment, defined as serum creatinine of 135 µmol/L (1.5 mg/dL) for males and 110 µmol/L (1.3 mg/dL) for females;
- Patients unable to communicate normally, such as those with dementia or cognitive impairment;
- Currently pregnant or planning to become pregnant in the near future;
- Other conditions preventing participation in follow-up interventions;
- Other clinical diseases that make participation in exercise unsuitable, such as inability to cooperate with exercise therapy due to severe pain or joint deformities, or the use of medications that may interfere with the assessment of exercise effects (such as corticosteroids, liver protection drugs, etc.), or medications that affect heart rate (such as beta-blockers).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fujian Provincial Hospital
Fuzhou, Fujian, 350001
Xiling Lin, 13777368507, linxiling@zju.edu.cn
About this study
Background: Metabolic dysfunction-associated fatty liver disease (MAFLD) is a liver condition primarily driven by metabolic dysfunctions that may progress to hepatitis, cirrhosis, and hepatocellular carcinoma. It is also implicated in the development of other metabolic dysfunction-related diseases. MAFLD has emerged as a growing public health concern in China. Despite its potential benefits, Tai Chi exercise has not been widely adopted for individuals with MAFLD, and there is limited research investigating its therapeutic efficacy. This study aims to evaluate the effects of a structured Tai Chi intervention on middle-aged and elderly individuals with MAFLD.
Methods: The study employs a comprehensive open, randomized, parallel, and controlled design. Eligible participants will be randomly allocated into three groups: Tai Chi, conventional exercise, and control. A total of 250 participants will be enrolled, comprising 100 participants each for the Tai Chi and conventional exercise groups and 50 for the control group. Both the Tai Chi and conventional exercise groups will participate in a structured 6-month exercise program. During the intervention, both groups will also receive regular health education on fatty liver disease. Participants will be encouraged to maintain their usual activities but will be advised against starting new exercise regimens. The control group will receive only health education on fatty liver disease. The primary efficacy endpoint is the change in hepatic triglyceride content measured via validated imaging techniques after 6 months. Secondary endpoints include changes in total body fat, waist circumference, body weight, blood pressure, blood lipids, blood glucose, insulin sensitivity, pancreatic beta-cell function, kidney function, and pulse wave velocity. Outcomes will be assessed at baseline and post-intervention.
Discussion: Tai Chi exercises demonstrate therapeutic potential in reducing intrahepatic fat content, promoting weight loss, and mitigating cardiovascular risk factors. Furthermore, their efficacy appears superior to that of conventional exercise modalities.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Tai Chi Exercise, Regular Exercise, Control
- Keywords
- MAFLD, Tai Chi, Intrahepatic Fat Content
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi ExerciseBehavioural
Tai Chi is a moderate-intensity exercise suitable for middle-aged and elderly individuals. Participants will engage in the practice five times a week (three sessions will be in-person teaching, and two will be online), with each session lasting 60 minutes, continuing until the end of a six-month follow-up. Before the intervention begins, participants will receive a manual or instructional video on Tai Chi to understand its principles, practice techniques, and safety precautions. Each class will start with a warm-up and include a review of Tai Chi principles and movements, breathing techniques, and relaxation methods. Participants will document their Tai Chi practice over 24 weeks by submitting exercise weekly logs, while researchers will monitor their exercise progress weekly via phone using standardized forms to assess frequency, completion status, adverse events, and adherence.
Regular ExerciseBehavioural
The intervention for middle-aged and elderly individuals includes a combination of common activities: 15 minutes of walking, 15 minutes of body coordination activities (including limb movements and balance training), 15 minutes of muscle stretching, and 15 minutes of relaxation. Each exercise session lasts for 60 minutes, conducted five days a week. The heart rate during exercise will be adjusted based on monthly fitness assessments, and the daily activity level will be evaluated through logs and fitness trackers.
ControlBehavioural
All participants will be advised not to change their existing lifestyle habits and will only receive health education related to fatty liver throughout the intervention. The educational methods will include large group sessions, individual education, and telephone follow-ups, conducted every two months. Additionally, dietary and exercise assessments will be carried out during the intervention, with dietary intake recorded using a three-day food diary to track daily calorie consumption.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi Exercise | Experimental | Tai Chi Exercise program, five times a week . Receives: Behavioral: Tai Chi Exercise |
| Regular Physical Activity | Experimental | Each exercise session lasts for 60 minutes, five days a week. Receives: Behavioral: Regular Exercise |
| Control | Other | Conduct health education on fatty liver once every two months. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Liver Fat Content
The liver is scanned using a SIEMENS 3.0T MRI (Magnetom Prisma, Siemens Healthineers, Germany). Participants lie supine, holding breath at end-expiration. A 3D multi-echo water-fat separation gradient echo sequence is used with parameters: TR 9.00 ms, TE1-6 at 1.05-7.38 ms, 4° flip angle, 450×394 mm FOV, 1.4×1.4×3.5 mm voxel size, 64 slices, 13 sec collection time. Images include in-phase, out-of-phase, water, fat, fat fraction, and R2* relaxation. Liver fat content (%) is measured in pseudocolor mode. ROIs are selected in liver's left lobe, central right lobe, and posterior right lobe below the portal vein at two levels, each 4 cm², avoiding bile ducts and vessels. Average fat content from 9 ROIs represents total liver fat content.
Measured: Baseline (month 0) to post-training (month 6)
Secondary outcomes (9)
Body weight
The measurement is conducted in the morning on an empty stomach, with advance notice given to participants.A standardized scale provided by the research center is placed on a flat surface.Participants are required to remove shoes, hats, and outerwear, and to wear only a single layer of clothing, removing any personal items such as wallets and phones.Participants stand calmly on the scale with their feet symmetrically positioned. Their bodies should be upright, arms naturally relaxed at their sides, head straight, and eyes looking forward.Measurements are taken twice, recording the average, ensuring that the discrepancy between the two measurements is less than 1.0 kg, with precision to 0.1 kg. Participants are advised to maintain an upright posture.
Measured: Baseline (month 0) to post-training (month 6)
Waist circumference
Waist circumference is measured in the morning after fasting. Subjects must stand upright with relaxed abdomen, arms down, and feet together. Use a metric tape at the midpoint between the lower ribs and upper iliac crest (about 1 cm above the navel), wrapped snugly but not compressing the skin. Subjects should breathe normally with a relaxed abdomen, and the measurement is taken at the end of exhalation, avoiding abdominal muscle contraction or breath holding. Repeat twice and record the average, ensuring measurements differ by less than 2 cm, accurate to 0.1 cm.
Measured: Time Frame: Baseline (month 0) to post-training (month 6)
Blood pressure
Subjects must avoid heavy exercise, training, eating, drinking (except water), caffeine, extreme temperatures, and blood pressure-altering meds before measuring. Stop smoking 30 min prior. Relax, empty bladder, rest 5 min. Measure BP in a comfortable room, seated naturally with back straight, palms up. Cuff on bare skin, 1-2 cm above inner elbow, not covering joint, tube aligned with middle finger. Cuff center at heart level. After one measurement, loosen cuff, let subject move arm slightly, then rest 1-2 min before next. Take three measurements, 1 min apart, to 1 mmHg precision.
Measured: Baseline (month 0) to post-training (month 6)
Grip strength of both hands
Using a calibrated hand dynamometer (Brand: CAMRY, Model: EH101).Subjects may stand or sit with their upper limbs naturally hanging at their sides. The palm should face the inner side of the body, with the handle of the dynamometer facing outward.Subjects should grip the dynamometer firmly to measure their grip strength, maintaining a stable posture without swinging the dynamometer back and forth during the measurement.Measure three times and record the maximum value. The dynamometer should be reset to zero before each measurement. Values should be recorded with a precision of 0.1 kg. The measurement can be conducted in the order of right hand followed by left hand.
Measured: Baseline (month 0) to post-training (month 6)
Body fat percentage
Using the BIA method, which calculates the proportion of fat and non-fat tissues based on the principle that well-hydrated tissues like muscles and blood vessels conduct electricity well, while fat tissue hardly conducts electricity at all.Measurements should be taken in a fasting state in the morning or more than 2 hours after a meal, with prior notification to the subjects; subjects should avoid vigorous exercise, saunas or baths, excessive alcohol consumption, and the intake of large amounts of water or food (1-2 hours before).Place the body fat analyzer (InBody 770, provided by the research center) on a flat, hard surface. The subject should stand barefoot on the foot electrodes of the body fat analyzer with dry skin, straighten the back and knees, raise the arms horizontally, extend the elbows, and position the arms at a 90° angle from the body with the palms pressed against the electrodes.Precision is to 0.1%.
Measured: Baseline (month 0) to post-training (month 6)
Total body fat
To measure total body fat, a DEXA densitometer scans subcutaneous fat and body composition. Subjects wear minimal clothing, remove metals, and lie centered on the scanning bed, aligned with the midline. For wider bodies, a half-body scan is possible. The scan includes the head, spine, and one side of the body, with the head 3 cm below the bed's horizontal line. Hands are positioned thumbs up, palms to legs, and arms alongside the body. Nylon straps secure knees and feet. Start the scan from the toolbar, monitor the image for full body display, and reposition if needed. Composition results show fat percentage, and detailed reports are printed from the Reports dialog box.
Measured: Baseline (month 0) to post-training (month 6)
Liver fibrosis scanning to determine liver stiffness
The FibroScan PRO-S by Echosens measures liver elasticity to assess hardness. Subjects lie supine with the right arm extended. Operators sit on the right, facing the subject and screen, placing the probe between ribs near the liver's right lobe, avoiding the edge. Use A-mode and M-mode to find a 6 cm deep, vascular-structure-free area, keeping the probe perpendicular to the skin. Press until the pressure indicator is green, then press the probe button for 1/10 sec data acquisition. Check the elastogram quality. For disinfection, end the exam, wipe off gel, and clean the probe tip with an alcohol-free disinfectant. Calibrate the probe every 12 months.
Measured: Baseline (month 0) to post-training (month 6)
Abdominal visceral fat
Abdominal visceral fat measurement is performed using the SIEMENS 3.0T MRI instrument (Magnetom Prisma, Siemens Healthinners, Erlangen, Germany). During the examination, subjects lie in a supine position and hold their breath while a single-layer cross-sectional MRI scan is taken at the L4-L5 level. After the acquisition, Image J software is used to analyze the area of abdominal visceral fat.
Measured: Baseline (month 0) to post-training (month 6)
Blood specimen
Lab tests include OGTT at 0, 30, 120 min, serum insulin at 0, 30, 120 min, HbA1c, lipids, liver and kidney function. Fasting blood is collected early morning by trained nurses. For OGTT (7-9 a.m.), subjects fast 8-10 hours and drink 75g anhydrous glucose in 300ml water (or 82.5g monohydrate) within 5 min. Blood samples are taken pre-test and at 30, 120 min post-glucose. Avoid tea, coffee, smoking, and heavy exercise. Samples are sent to Fujian Provincial Hospital lab for uniform testing, following standards and accredited.
Measured: Baseline (month 0) to post-training (month 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Nov 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- 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
- Model description
- The study design utilizes an open, randomized, parallel, controlled approach. A total of 250 middle-aged and elderly subjects with metabolic associated fatty liver disease are recruited. Participants are randomly assigned in a 2:2:1 ratio to the Tai Chi group, conventional exercise group, and control group, with the entire intervention period lasting for 6 months.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Provincial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiling lLIN, Fujian Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717828
- Sponsor's protocol ID
- 202410081053000483865
- Status last verified
- Dec 2024
- First submitted
- 1 Dec 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Tai Chi on Metabolic Dysfunction-associated Fatty Liver Disease in Middle-Aged and Older Adults
- ClinicalTrials.gov ID
- NCT06717828
- Acronym / sponsor ID
- 202410081053000483865
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- MAFLD, Tai Chi, Intrahepatic Fat Content
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Fujian Provincial HospitalUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Dec 2024 (actual)
- 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.
Background: Metabolic dysfunction-associated fatty liver disease (MAFLD) is a liver condition primarily driven by metabolic dysfunctions that may progress to hepatitis, cirrhosis, and hepatocellular carcinoma. It is also implicated in the development of other metabolic dysfunction-related diseases. MAFLD has emerged as a growing public health concern in China. Despite its potential benefits, Tai Chi exercise has not been widely adopted for individuals with MAFLD, and there is limited research investigating its therapeutic efficacy. This study aims to evaluate the effects of a structured Tai Chi intervention on middle-aged and elderly individuals with MAFLD.
Methods: The study employs a comprehensive open, randomized, parallel, and controlled design. Eligible participants will be randomly allocated into three groups: Tai Chi, conventional exercise, and control. A total of 250 participants will be enrolled, comprising 100 participants each for the Tai Chi and conventional exercise groups and 50 for the control group. Both the Tai Chi and conventional exercise groups will participate in a structured 6-month exercise program. During the intervention, both groups will also receive regular health education on fatty liver disease. Participants will be encouraged to maintain their usual activities but will be advised against starting new exercise regimens. The control group will receive only health education on fatty liver disease. The primary efficacy endpoint is the change in hepatic triglyceride content measured via validated imaging techniques after 6 months. Secondary endpoints include changes in total body fat, waist circumference, body weight, blood pressure, blood lipids, blood glucose, insulin sensitivity, pancreatic beta-cell function, kidney function, and pulse wave velocity. Outcomes will be assessed at baseline and post-intervention.
Discussion: Tai Chi exercises demonstrate therapeutic potential in reducing intrahepatic fat content, promoting weight loss, and mitigating cardiovascular risk factors. Furthermore, their efficacy appears superior to that of conventional exercise modalities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The study design utilizes an open, randomized, parallel, controlled approach. A total of 250 middle-aged and elderly subjects with metabolic associated fatty liver disease are recruited. Participants are randomly assigned in a 2:2:1 ratio to the Tai Chi group, conventional exercise group, and control group, with the entire intervention period lasting for 6 months.
| Arm | Type | Receives |
|---|---|---|
| Tai Chi Exercise | Experimental | Behavioral: Tai Chi ExerciseTai Chi Exercise program, five times a week . |
| Regular Physical Activity | Experimental | Behavioral: Regular ExerciseEach exercise session lasts for 60 minutes, five days a week. |
| Control | Other | Behavioral: ControlConduct health education on fatty liver once every two months. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 40 and 75 years;
- Liver fat content measured by mDixon QUANT is ≥5%;
- Diagnosis of metabolic associated fatty liver disease;
- Overweight/obesity (BMI ≥ 24 kg/m²);
- Signed written informed consent.
Key exclusion criteria (12 listed)
- Excessive alcohol consumption (definition: in the past 6 months, males have consumed more than 140g of alcohol per week, and females have consumed more than 70g);
- Fatty liver due to other causes: such as alcoholic fatty liver, acute and chronic viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, etc.;
- Severe cardiovascular diseases, including myocardial infarction within the past 6 months;
- Heart failure (NYHA classification: III - IV);
- Biliary diseases: such as obstructive biliary diseases;
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 |
|---|---|---|
| Tai Chi ExerciseTai Chi is a moderate-intensity exercise suitable for middle-aged and elderly individuals. Participants will engage in the practice five times a week (three sessions will be in-person teaching, and two will be online), with each session lasting 60 minutes, continuing until the end of a six-month follow-up. Before the intervention begins, participants will receive a manual or instructional video on Tai Chi to understand its principles, practice techniques, and safety precautions. Each class will start with a warm-up and include a review of Tai Chi principles and movements, breathing techniques, and relaxation methods. Participants will document their Tai Chi practice over 24 weeks by submitting exercise weekly logs, while researchers will monitor their exercise progress weekly via phone using standardized forms to assess frequency, completion status, adverse events, and adherence. | Behavioural | Tai Chi Exercise |
| Regular ExerciseThe intervention for middle-aged and elderly individuals includes a combination of common activities: 15 minutes of walking, 15 minutes of body coordination activities (including limb movements and balance training), 15 minutes of muscle stretching, and 15 minutes of relaxation. Each exercise session lasts for 60 minutes, conducted five days a week. The heart rate during exercise will be adjusted based on monthly fitness assessments, and the daily activity level will be evaluated through logs and fitness trackers. | Behavioural | Regular Physical Activity |
| ControlAll participants will be advised not to change their existing lifestyle habits and will only receive health education related to fatty liver throughout the intervention. The educational methods will include large group sessions, individual education, and telephone follow-ups, conducted every two months. Additionally, dietary and exercise assessments will be carried out during the intervention, with dietary intake recorded using a three-day food diary to track daily calorie consumption. | Behavioural | Control |
Primary outcome
Determination of Liver Fat Content
Time frame: Baseline (month 0) to post-training (month 6)
The liver is scanned using a SIEMENS 3.0T MRI (Magnetom Prisma, Siemens Healthineers, Germany). Participants lie supine, holding breath at end-expiration. A 3D multi-echo water-fat separation gradient echo sequence is used with parameters: TR 9.00 ms, TE1-6 at 1.05-7.38 ms, 4° flip angle, 450×394 mm FOV, 1.4×1.4×3.5 mm voxel size, 64 slices, 13 sec collection time. Images include in-phase, out-of-phase, water, fat, fat fraction, and R2* relaxation. Liver fat content (%) is measured in pseudocolor mode. ROIs are selected in liver's left lobe, central right lobe, and posterior right lobe below the portal vein at two levels, each 4 cm², avoiding bile ducts and vessels. Average fat content from 9 ROIs represents total liver fat content.
9 secondary outcomes
Body weight
Time frame: Baseline (month 0) to post-training (month 6)
Waist circumference
Time frame: Time Frame: Baseline (month 0) to post-training (month 6)
Blood pressure
Time frame: Baseline (month 0) to post-training (month 6)
Grip strength of both hands
Time frame: Baseline (month 0) to post-training (month 6)
Body fat percentage
Time frame: Baseline (month 0) to post-training (month 6)
Total body fat
Time frame: Baseline (month 0) to post-training (month 6)
Liver fibrosis scanning to determine liver stiffness
Time frame: Baseline (month 0) to post-training (month 6)
Abdominal visceral fat
Time frame: Baseline (month 0) to post-training (month 6)
Blood specimen
Time frame: Baseline (month 0) to post-training (month 6)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi Exercise and Regular Exercise in people with Non-Alcoholic Fatty Liver Disease, run by Fujian Provincial Hospital at 1 site in China.
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 5 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 5 Dec 2024. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of Liver Fat Content (time frame: Baseline (month 0) to post-training (month 6)). 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 5 Dec 2024.