Overweight and ObesityNCT04919603
Impact of Exercise Intervention on the Phenome
A study testing Enhanced physical activity intervention and Standard education in people with Overweight and Obesity and Physical Activity, run by Shanghai Jiao Tong University School of Medicine at 2 sites in China.
Trial summary
It is an open-label, parallel-group, randomized controlled clinical trial, which is designed to enroll people with different glucose metabolism status who are also overweight or obese, including people with normal glucose metabolism, pre-diabetes patients and newly diagnosed type 2 diabetes patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight and Obesity, Physical Activity
- What is being tested?
- Enhanced physical activity intervention and Standard education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 2 sitesChina
- Study dates
- 15 Jun 2021to 30 May 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18-65 years;
- Normal glucose metabolism or pre-diabetes or newly diagnosed type 2 diabetes
- Normal glucose metabolism:
- FBG<5.6mmol/L and
- 2h-PG<7.8mmol/L and
- HbA1c<5.7%;
Show all 14Show fewer
- Pre-diabetes:
- 5.6mmol/L ≤ FBG ≤ 6.9mmol/L and/or
- 7.8mmol/L ≤ 2h-PG ≤ 11.0mmol/L and/or
- 5.7% ≤ HbA1c ≤ 6.4%;
- Newly diagnosed diabetes:
- o Duration of type 2 diabetes is less than 5 years;
- No insulin treatment;
- 23 Kg/m2 ≤ Body mass index (BMI) <40 Kg/m2;
Who cannot join
- Eligibility Minimum Age: 18 Years Maximum Age: 65 Years Sex: All Gender Based: No Accepts Healthy Volunteers: No
- Criteria: Inclusion Criteria:
- Men and women aged 18-65 years;
- Normal glucose metabolism or pre-diabetes or newly diagnosed type 2 diabetes
- Normal glucose metabolism:
- FBG<5.6mmol/L and
Show all 40Show fewer
- 2h-PG<7.8mmol/L and
- HbA1c<5.7%;
- Pre-diabetes:
- 5.6mmol/L ≤ FBG ≤ 6.9mmol/L and/or
- 7.8mmol/L ≤ 2h-PG ≤ 11.0mmol/L and/or
- 5.7% ≤ HbA1c ≤ 6.4%;
- Newly diagnosed diabetes:
- o Duration of type 2 diabetes is less than 5 years;
- No insulin treatment;
- 23 Kg/m2 ≤ Body mass index (BMI) <40 Kg/m2;
- Severe cardiovascular disease:
- current angina
- myocardial infarction or stroke within last six months
- heart failure (NYHA grading III~IV)
- symptomatic periphery vascular disease
- Uncontrolled hypertension: systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg;
- Myocardial ischemia indicated by resting ECG;
- Cardiac dysfunction indicated by Echocardiogram;
- Abnormal HS-TNT or NT-proBNP concentration;
- Foot ulcers, peripheral neuropathy or skeletal disorders;
- Taking high intensity exercise more than 75 minutes or moderate intensity exercise more than 150 minutes per week during the screening phase
- ALT or AST levels more than three times the upper limit of the normal range or active liver diseases;
- eGFR <60 ml/min/1.73 m2, or serum creatinine >1.5 mg/dl for men or 1.3mg/dl for women; or macro albuminuria (urine albumin/creatinine>300mg/g)
- Malignant tumor in active-stage, or in remission stage but less than 5 years from the most recent treatment
- Past or present confirmed psychiatric illness or drug dependence;
- Currently taking medications known to affect weight (e.g. anti thyroid drugs, glucocorticoids);
- Known to have weight-affecting diseases (e.g. malabsorption, functional bowel disease, uncontrolled low sodium/hyperthyroidism, eating disorders);
- Known to have metabolism-affecting diseases;
- Other acute diseases supported by clinical evidence which may contradict to the interventions;
- Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control;
- Currently participating in another intervention study;
- Failure to obtain informed consent from participant;
- Any factors judged by the clinic team to be likely to limit adherence to interventions;
- Any other medical condition judged by the clinic team not eligible for the trial.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
The Third People's Hospital of Datong City
Datong, Shanxi
Yan Liu, MS
- Not yet recruiting
Shanghai Institute of Endocrine and Metabolic Diseases
Shanghai, Shanghai Municipality, 200025
Mian Li, MD,PhD, +862164370045, limian39@aliyun.com
Yufang Bi, MD, PhD
About this study
Official title: Impact of Exercise Intervention on the Phenome (Metabolism and Predictive Complications) in Well Characterised Pre-diabetes and New Onset Type 2 Diabetes Cohorts in China
It is an open-label, parallel-group, randomized controlled clinical trial, which is designed to enroll people with different glucose metabolism status who are also overweight or obese, including people with normal glucose metabolism, pre-diabetes patients and newly diagnosed type 2 diabetes patients. The patients are randomized to an enhanced physical activity intervention (high-intensity interval training exercise prescription combined with resistance training) or standard education group (diabetes health education only, including lifestyle education and guidance) for 12 weeks. This trial intends to compare the influence of enhanced physical activity treatment with that of a standard education on liver steatosis, serum glucose and lipids level, insulin sensitivity, cardiovascular metabolic parameters, metabolic molecules, and gut microbiota profile et al.
Read the detailed description
The trial will recruit 270 patients from 2 hospitals within the China Diabetes Clinical Research Network. Eligible criteria include men and women aged 18-65 years; with normal glucose metabolism or pre-diabetes or newly diagnosed type 2 diabetes; no insulin treatment; BMI ≥23 kg/m2 and <40 kg/m2. Main exclusion criteria include severe cardiovascular diseases, uncontrolled hypertension, and other serious illness. The proposed trial has 90% statistical power to detect an absolute 3.0% reduction of liver triglyceride level changes between intensive physical activity intervention and standard education groups at a 2-sided significance level of 0.05. To achieve the proposed study objectives, we plan to perform the following specific aims:
- Recruit 270 study participants who meet the eligibility criteria, including 90 people with normal glucose metabolism, 90 pre-diabetes patients and 90 newly diagnosed type 2 diabetes patients, and randomly assign 135 to the enhanced physical activity intervention group and 135 to the standard education group for 12 weeks;
- Employ a study-wide strategy to encourage standard of care for all participants for the treatment of type 2 diabetes and other metabolic disorders;
- Obtain clinical data on study outcomes for up to 12 months of follow-up among all trial participants;
- Perform strict quality control procedures for intervention and data collection;
- Conduct data analysis according to the intention-to-treat principle;
- Disseminate the study findings to influence clinical practice and clinical guidelines.
The results will be analyzed to examine the pan-omics changes after the interventions and clarify their predictive benefits on the effects of the interventions.
- Conditions
- Overweight and Obesity, Physical Activity
- Being tested
- Enhanced physical activity intervention, Standard education
- Medical subject headings
- Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced physical activity interventionBehavioural
the participants will take high-intensity exercise in accordance with High Intensity Interval Training (HIIT) prescriptions, with maximum heart rate and relative maximal oxygen uptake monitored. They will take both aerobic and resistance training exercise consecutively, and total training time will be expected to reach at least 150 minutes per week.
Standard educationBehavioural
the participants will receive no extra intervention but diabetes health education, which will be carried out in large classrooms, in groups, and over the telephone. The education is mainly consisted of instructions on diabetes prevention according to < Guidelines for prevention and treatment of type 2 diabetes in China (2017 edition)
| Study group | Role | What they receive |
|---|---|---|
| Enhanced physical activity group | Experimental | the participants will take high-intensity exercise in accordance with High Intensity Interval Training (HIIT) prescriptions, with maximum heart rate and relative maximal oxygen uptake monitored. They will take both aerobic and resistance training exercise consecutively, and total training time will be expected to reach at least 150 minutes per week. Receives: Behavioral: Enhanced physical activity intervention |
| Standard education group | Experimental | the participants will receive no extra intervention but diabetes health education, which will be carried out in large classrooms, in groups, and over the telephone. The education is mainly consisted of instructions on diabetes prevention according to < Guidelines for prevention and treatment of type 2 diabetes in China (2017 edition)telephone. The education is mainly consisted of instructions on diabetes prevention according to < Guidelines for prevention and treatment of type 2 diabetes in China (2017 edition)>. Receives: Behavioral: Standard education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in liver steatosis quantified by MRI-PDFF (percentage)
Measured: 12 weeks
Secondary outcomes (30)
Change in liver steatosis quantified by MRI-PDFF (percentage)
Measured: 1 year
Change in the level of fasting blood glucose (mmol/l)
Measured: 12 weeks and 1 year
Change in the level of plasma glucose of 2 hours post glucose-load (mmol/l)
Measured: 12 weeks and 1 year
Change in the level of HbA1c (percentage)
Measured: 12 weeks and 1 year
Change in body mass index (BMI)
Body weight (kg) and height (m) will be combined to report BMI in kg/m^2
Measured: 12 weeks and 1 year
Change in waist circumstance (cm)
Measured: 12 weeks and 1 year
Change in body fat level (%)
Quantified by bioelectrical impedance analysis in a human body composition analyzer
Measured: 12 weeks and 1 year
Change in serum non-HDL-C level (mg/dl)
Measured: 12 weeks and 1 year
Change in serum total cholesterol level (mg/dl)
Measured: 12 weeks and 1 year
Change in serum VLDL-C level (mg/dl)
Measured: 12 weeks and 1 year
Change in serum LDL-C level (mg/dl)
Measured: 12 weeks and 1 year
Change in serum HDL-C level (mg/dl)
Measured: 12 weeks and 1 year
Change in serum ApoB level (mg/dl)
Measured: 12 weeks and 1 year
Change in basal metabolic rate (BMR) (Kcal)
Quantified by bioelectrical impedance analysis in a human body composition analyzer
Measured: 12 weeks and 1 year
Change in blood pressure (mmHg)
Measured: 12 weeks and 1 year
Change in heart rate
Measured: 12 weeks and 1 year
Change in insulin sensitivity
Quantify by HOMA score, which is calculated multiplying fasting plasma insulin (FPI, mIU/L) by fasting plasma glucose (FPG, mmol/L), then dividing by the constant 22.5, i.e. HOMA-IR = (FPI×FPG)/22.5.
Measured: 12 weeks and 1 year
Change in islet β-cell function
Quantify by HOMA score, which is calculated with fasting plasma insulin (FPI, mIU/L) and fasting plasma glucose (FPG, mmol/L), i.e. HOMA-β = 20*FPI/(FPG-3.5).
Measured: 12 weeks and 1 year
Change in serum fetuin-A concentration (μg/mL)
Measured: 12 weeks and 1 year
Change in serum GREM2 concentration (pg/ml)
Measured: 12 weeks and 1 year
Change in gut hormones, monocyte subtypes and other serum biomarkers
Measured: 12 weeks and 1 year
Change in metabolic molecules concentration
Measured: 12 weeks and 1 year
Change in microRNA concentration
Measured: 12 weeks and 1 year
Change in overall gut microbiota profile
change in gut microbiota composition and proportion of specific gut flora.
Measured: 12 weeks and 1 year
Depression
Evaluated with PHQ-9 scores. The PHQ is 59-question instrument, referring to the level of interest in doing things, feeling down or depressed, difficulty with sleeping, energy levels, eating habits, self-perception, ability to concentrate, speed of functioning and thoughts of suicide. Responses range from "0" (Not at all) to "3" (nearly every day).The total sum of the responses suggests varying levels of depression. Scores range from 0 to 27. In general, a total of 10 or above is suggestive of the presence of depression.
Measured: 12 weeks and 1 year
Health related quality of life
Evaluated with HQoL scales such as Short Form 12 Health Survey Questionnaire. The SF-12 is 12-question instrument, covering the eight domains of health outcomes, including physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 48. A higher score indicates a better health state.
Measured: 12 weeks and 1 year
Change in diet pattern
Evaluated with a semiquantitative food frequency questionnaire.
Measured: 12 weeks and 1 year
Change in sleeping pattern
Evaluated with Pittsburgh Sleep Quality Index, PSQI. Scores range from 0 to 21. A higher score indicates a worse sleeping pattern.
Measured: 12 weeks and 1 year
Change in daily exercise
Evaluated with short form International Physical Activity Questionnaire (IPAQ).
Measured: 12 weeks and 1 year
Cardiovascular risk
Evaluated with Framingham Risk Scores. Individuals with low risk have 10% or less CHD risk at 10 years, with intermediate risk 10-20%, and with high risk 20% or more.
Measured: 12 weeks and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start15 Jun 2021 (estimated)
- Primary completion30 May 2022 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guang Ning, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919603
- Sponsor's protocol ID
- 1.0/2020-07-29
- Status last verified
- Jun 2021
- First submitted
- 22 Apr 2021
- Last updated
- 9 Jun 2021
- 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 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Exercise Intervention on the Phenome (Metabolism and Predictive Complications) in Well Characterised Pre-diabetes and New Onset Type 2 Diabetes Cohorts in China
- ClinicalTrials.gov ID
- NCT04919603
- Acronym / sponsor ID
- 1.0/2020-07-29
- Conditions
- Overweight and Obesity, Physical Activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 15 Jun 2021 (estimated)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 9 Jun 2021 (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.
It is an open-label, parallel-group, randomized controlled clinical trial, which is designed to enroll people with different glucose metabolism status who are also overweight or obese, including people with normal glucose metabolism, pre-diabetes patients and newly diagnosed type 2 diabetes patients. The patients are randomized to an enhanced physical activity intervention (high-intensity interval training exercise prescription combined with resistance training) or standard education group (diabetes health education only, including lifestyle education and guidance) for 12 weeks. This trial intends to compare the influence of enhanced physical activity treatment with that of a standard education on liver steatosis, serum glucose and lipids level, insulin sensitivity, cardiovascular metabolic parameters, metabolic molecules, and gut microbiota profile et al.
Detailed description
The trial will recruit 270 patients from 2 hospitals within the China Diabetes Clinical Research Network. Eligible criteria include men and women aged 18-65 years; with normal glucose metabolism or pre-diabetes or newly diagnosed type 2 diabetes; no insulin treatment; BMI ≥23 kg/m2 and <40 kg/m2. Main exclusion criteria include severe cardiovascular diseases, uncontrolled hypertension, and other serious illness. The proposed trial has 90% statistical power to detect an absolute 3.0% reduction of liver triglyceride level changes between intensive physical activity intervention and standard education groups at a 2-sided significance level of 0.05. To achieve the proposed study objectives, we plan to perform the following specific aims:
- Recruit 270 study participants who meet the eligibility criteria, including 90 people with normal glucose metabolism, 90 pre-diabetes patients and 90 newly diagnosed type 2 diabetes patients, and randomly assign 135 to the enhanced physical activity intervention group and 135 to the standard education group for 12 weeks;
- Employ a study-wide strategy to encourage standard of care for all participants for the treatment of type 2 diabetes and other metabolic disorders;
- Obtain clinical data on study outcomes for up to 12 months of follow-up among all trial participants;
- Perform strict quality control procedures for intervention and data collection;
- Conduct data analysis according to the intention-to-treat principle;
- Disseminate the study findings to influence clinical practice and clinical guidelines.
The results will be analyzed to examine the pan-omics changes after the interventions and clarify their predictive benefits on the effects of the interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced physical activity group | Experimental | Behavioral: Enhanced physical activity interventionthe participants will take high-intensity exercise in accordance with High Intensity Interval Training (HIIT) prescriptions, with maximum heart rate and relative maximal oxygen uptake monitored. They will take both aerobic and resistance training exercise consecutively, and total training time will be expected to reach at least 150 minutes per week. |
| Standard education group | Experimental | Behavioral: Standard educationthe participants will receive no extra intervention but diabetes health education, which will be carried out in large classrooms, in groups, and over the telephone. The education is mainly consisted of instructions on diabetes prevention according to < Guidelines for prevention and treatment of type 2 diabetes in China (2017 edition)telephone. The education is mainly consisted of instructions on diabetes prevention according to < Guidelines for prevention and treatment of type 2 diabetes in China (2017 edition)>. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Men and women aged 18-65 years;
- Normal glucose metabolism or pre-diabetes or newly diagnosed type 2 diabetes
- o Duration of type 2 diabetes is less than 5 years;
- No insulin treatment;
- 23 Kg/m2 ≤ Body mass index (BMI) <40 Kg/m2;
Key exclusion criteria (40 listed)
- Eligibility Minimum Age: 18 Years Maximum Age: 65 Years Sex: All Gender Based: No Accepts Healthy Volunteers: No
- Men and women aged 18-65 years;
- Normal glucose metabolism or pre-diabetes or newly diagnosed type 2 diabetes
- o Duration of type 2 diabetes is less than 5 years;
- No insulin treatment;
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 |
|---|---|---|
| Enhanced physical activity interventionthe participants will take high-intensity exercise in accordance with High Intensity Interval Training (HIIT) prescriptions, with maximum heart rate and relative maximal oxygen uptake monitored. They will take both aerobic and resistance training exercise consecutively, and total training time will be expected to reach at least 150 minutes per week. | Behavioural | Enhanced physical activity group |
| Standard educationthe participants will receive no extra intervention but diabetes health education, which will be carried out in large classrooms, in groups, and over the telephone. The education is mainly consisted of instructions on diabetes prevention according to < Guidelines for prevention and treatment of type 2 diabetes in China (2017 edition) | Behavioural | Standard education group |
Primary outcome
Change in liver steatosis quantified by MRI-PDFF (percentage)
Time frame: 12 weeks
30 secondary outcomes
Change in liver steatosis quantified by MRI-PDFF (percentage)
Time frame: 1 year
Change in the level of fasting blood glucose (mmol/l)
Time frame: 12 weeks and 1 year
Change in the level of plasma glucose of 2 hours post glucose-load (mmol/l)
Time frame: 12 weeks and 1 year
Change in the level of HbA1c (percentage)
Time frame: 12 weeks and 1 year
Change in body mass index (BMI)
Time frame: 12 weeks and 1 year
Change in waist circumstance (cm)
Time frame: 12 weeks and 1 year
Change in body fat level (%)
Time frame: 12 weeks and 1 year
Change in serum non-HDL-C level (mg/dl)
Time frame: 12 weeks and 1 year
Change in serum total cholesterol level (mg/dl)
Time frame: 12 weeks and 1 year
Change in serum VLDL-C level (mg/dl)
Time frame: 12 weeks and 1 year
Change in serum LDL-C level (mg/dl)
Time frame: 12 weeks and 1 year
Change in serum HDL-C level (mg/dl)
Time frame: 12 weeks and 1 year
Change in serum ApoB level (mg/dl)
Time frame: 12 weeks and 1 year
Change in basal metabolic rate (BMR) (Kcal)
Time frame: 12 weeks and 1 year
Change in blood pressure (mmHg)
Time frame: 12 weeks and 1 year
Change in heart rate
Time frame: 12 weeks and 1 year
Change in insulin sensitivity
Time frame: 12 weeks and 1 year
Change in islet β-cell function
Time frame: 12 weeks and 1 year
Change in serum fetuin-A concentration (μg/mL)
Time frame: 12 weeks and 1 year
Change in serum GREM2 concentration (pg/ml)
Time frame: 12 weeks and 1 year
Change in gut hormones, monocyte subtypes and other serum biomarkers
Time frame: 12 weeks and 1 year
Change in metabolic molecules concentration
Time frame: 12 weeks and 1 year
Change in microRNA concentration
Time frame: 12 weeks and 1 year
Change in overall gut microbiota profile
Time frame: 12 weeks and 1 year
Depression
Time frame: 12 weeks and 1 year
Health related quality of life
Time frame: 12 weeks and 1 year
Change in diet pattern
Time frame: 12 weeks and 1 year
Change in sleeping pattern
Time frame: 12 weeks and 1 year
Change in daily exercise
Time frame: 12 weeks and 1 year
Cardiovascular risk
Time frame: 12 weeks and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced physical activity intervention and Standard education in people with Overweight and Obesity and Physical Activity, run by Shanghai Jiao Tong University School of Medicine at 2 sites 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 14 inclusion and 40 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: status not confirmed, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yufang Bi, MD, PhD (+862164370045, byf10784@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in liver steatosis quantified by MRI-PDFF (percentage) (time frame: 12 weeks). 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 9 Jun 2021.