AdiposityNCT04787952
Insight Into New Brown Adipose Tissue Activators.
An observational study of Adiposity and Metabolic Complication, run by Medical University of Bialystok.
Trial summary
The general purpose of the study was to provide new information about the role of macronutrients intake, metabolomics, proteomics and microRNA on BAT activation. The invesigator evaluated BAT activity and whole body energy consumption under cold stimulation in two gruops of healthy males aged 21-43 years old with… Read more about this study
- Who is it for?
- Ages 20 to 43 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Adiposity, Metabolic Complication, Metabolic Disturbance
- What is being tested?
- cold expossure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 24 Feb 2018
- Phase
- Observational
- 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 20 to 43 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: The study group comprised of 28 young, healthy, non - smoking Caucasian males, aged 21-42 years (mean age 26.75 ±5.11 years old), 16 with normal body weight (BMI < 25 kg/m2) and 12 obese/overweight (BMI > 25 kg/m2). Only participants without any comorbidities (e.g. hypo- and hyperthyroidis, asthma, cardiovascular disease, renal and liver failure, etc.) as well as without any medications (beta-blockers etc.) that could have impact on results, were enrolled to the study. Outside and shift workers have been excluded from the study as well.
Who may be able to join
- BMI <25 kg/m2;
- RR<140/90mmHg;
- age 20-30/40 years
- fasting glycemia <100mg/dl; 2h-OGTT <140mg/dl;
- no chronic disease
- Inclusion criteria to the group 2 ( overweight/obese males) N=20:
Show all 10Show fewer
- Blood pressure < 140/90 mmHg (well controlled by inh ACE; no beta-blockers)
- No chronic disease
- BMI > 25 <35kg/m²
- fasting glycemia <100mg/dl; 2h-OGTT <140mg/dl;
Who cannot join
- Any drug use: beta-blokers, statins, glucocorticoids drugs, hypertension drugs;
- hypertension;
- cancer;
- hormonal disorders;
- Inflammation process
- Smoking
- Claustrophobia
About this study
Official title: Searching for the New Mechanisms That Activate Brow Fat Tissue
The general purpose of the study was to provide new information about the role of macronutrients intake, metabolomics, proteomics and microRNA on BAT activation.
The invesigator evaluated BAT activity and whole body energy consumption under cold stimulation in two gruops of healthy males aged 21-43 years old with normal BMI ( 19-25kg/m2) and in overweight/obese subjects.
Read the detailed description
In detail, the main objectives of this study was to measure the influence of biological molecules of such fields: genomics, transcriptomics metabolomics and protemics and its relationship on BAT activation. The investigator also evaluated the role of diet, macronutirnets intake and polyunsaturated fatty acids on BAT activity.
Study design:
- SCREENING VISIT:
- obtaining written informed consent from all subjects
- physical examination
- body composition analysis ( DXA + bioindepedance method inbody 720)
Laboratory analyses:
- Oral glucose tolerance test ( OGGT 75g)
- Morphology
- CRP
- Creatinine
- Urine analysis
- Lipids profile
- TSH
- ALT,AST
Dietary analysis All subjects fulfilled a 3-day food diary. Subjects were asked to compare the portion sizes with the colour photographs of each portion size, and to weigh food, if possible. The daily total energy, macronutrients, monounsaturated fatty acids (MUFA), polyunsaturated fatty acids (PUFA), omega-3, and omega-6 fatty acids intake were analysed.
- STUDY VISITS: Patients who met the inclusion criteria and passed the screening stage were invited for the first visit when PET / MRI after 2h of cold exposure was performed.
Subjects were studied in the morning, from approximately 8 a.m. to 12 a.m., after an overnight fast beginning at 10 p.m. the night before. At the beginning of the day on which the PET study was performed, a catheter was inserted in the subject's antecubital vein for a bolus injection of 18F-FDG. Another catheter was inserted in the antecubital vein of the contralateral arm and was used to obtain samples of venous blood.
The subjects rested in a supine position under thermoneutral conditions (22°C) for 1 hour and then participants were exposed to cooling for 2 hours. The water perfused blankets were used in the applied protocol of cooling. Blood samples were taken before as well as in 60th and 120th min of cooling. Subjects were cooled until shivering and then temperature is set slightly (1-2°C) above the temperature that causes the onset of shivering. Shivering were confirmed by visual inspection and by asking the subject each 15 min. After 2 hour the tracer 18F-FDG (4 MBq/kg ) was administered intravenously, and scanning was performed after the injection of tracer.
Skin temperatures were measured continually by means of electrode attached to skin below armpit.
During the cold exposure, whole body resting energy expenditure (REE) was assessed by a computed open-circuit indirect calorimetry method- based on the consumption of O2 and the production of CO2. The 30 min long measurements of resting oxygen uptake and resting carbon dioxide production were performed by a ventilated canopy Vmax Encore 29n System (Viasys HealthCare, Yorba Linda, CA, USA) at the baseline ( -30 min to 0 min) and every 30 min until 120 min of cold exposure.
During PET-MRI scanning blood samples were taken in 5', 10' 20' 30' 40' to check the activity of 18-FDG. After PET/MRI patient's urine was collected and analyzed for activity of tracer. Blood samples were taken for analysis before the cold exposure, at 60 min and 120 min during the cold exposure to evaluate:
Glucose, IL-6, Insulin, Free Fatty Acids (FFA), TSH, fT4,fT3, Irisin, Atrial natriuretic peptide (ANP), Brain natriuretic peptide (BNP), plasma nonesterified fatty acid (NEFA), DNA, Peripheral Blood Mononuclear Cell (PBMC) for microRNA isolation, metabolomics and proteomics analysis.
SUMMARY:
The goal of our study is to search for new mechanisms that stimulate activation of BAT. It is likely that individuals with different content and activity of the brown adipose will have different set of serum markers after exposure to cold. This will allow the identification of new biomarkers and to understand the molecular mechanisms responsible for the activation of the brown adipose tissue. The outcomes will enable to find new potential therapeutic and diagnostic applications given to the current obesity pandemic.
- Conditions
- Adiposity, Metabolic Complication, Metabolic Disturbance, Healthy, Obesity, Diet Habit
- Being tested
- cold expossure
- Keywords
- brown adipose tissue, obesity, diabetes type 2
- Medical subject headings
- Obesity, Feeding Behavior, Nutritional and Metabolic Diseases, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold expossureOther
subjects were exposed for the cold, to activate and diagnose potential brown tissue activity
| Study group | Role | What they receive |
|---|---|---|
| Group 1= healthy subjects | Inclusion criteria to the group 1 (healthy males) N=20:
1. BMI <25 kg/m2;
2. RR<140/90mmHg;
3. age 21-43 years
4. fasting glycemia <100mg/dl; 2h-OGTT <140mg/dl;
5. no chronic disease Receives: Other: cold expossure | |
| Group 2 = overweight/obese subjects | Inclusion criteria to the group 2 ( overweight/obese males ) N=20:
1. Blood pressure < 140/90 mmHg (well controlled by inh ACE; no beta-blockers)
2. No chronic disease
3. BMI > 25 <35kg/m²
4. fasting glycemia <100mg/dl; 2h-OGTT <140mg/dl;
5. age 21-43 years Receives: Other: cold expossure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The potential associations between BAT activity and dietary intake
The relationship between BAT activity and dietary intake will be analyzed
Measured: 2016-2018
The potential associations between BAT activity and metabolite profile
The potential molecules will be identified by metabolomics approach and will be analyzed dependently on the brown tissue activity level
Measured: the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure
The potential associations between BAT activity and proteins profile
The potential molecules will be identified by proteomics approach and will be analyzed dependently on the brown tissue activity level
Measured: the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure
The potential associations between BAT activity and transcriptome profile
The potential molecules will be identified by transriptomics approach and will be analyzed dependently on the brown tissue activity level
Measured: the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure
Secondary outcomes (13)
The potential associations between BAT activity and Interleukin-6 concentrations
The IL-6 concentration was measured before and during cold exposure and analyzed dependently on brown adipose tissue activity
Measured: the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure
The potential associations between BAT activity and energy expenditure
The energy expenditure was measured before and during the cold exposure, and analyzed dependently on brown adipose tissue activity
Measured: at the baseline ( -30 min to 0 min) and every 30 min until 120 min of cold exposure
The potential associations between BAT activity and substrates utilization
The substrates utilization was measured before and during the cold exposure, and analyzed dependently on brown adipose tissue activity
Measured: at the baseline ( -30 min to 0 min) and every 30 min until 120 min of cold exposure.
The potential associations between BAT activity and glucose concentrations
The glucose concentration was measured before and during cold exposure and analyzed dependently on brown adipose tissue activity
Measured: he baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure
The potential associations between BAT activity and insulin concentrations
The insulin concentration was measured before and during cold exposure and analyzed dependently on brown adipose tissue activity
Measured: the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure
The potential associations between BAT activity and FFA ( free fatty acids) concentrations
The FFA concentration was measured before and during cold exposure and analyzed dependently on brown adipose tissue activity
Measured: the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure
The potential associations between BAT activity and irisin concentrations
The irisin concentration was measured before and during cold exposure and analyzed dependently on brown adipose tissue activity
Measured: the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure
The potential associations between BAT activity and atrial natiuretic peptide concentrations
The atrial natriuretic peptide concentration was measured before and during cold exposure and analyzed dependently on brown adipose tissue activity
Measured: the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure
The potential associations between BAT activity and brain natiuretic peptide concentrations
The brain natriuretic peptide concentration was measured before and during cold exposure and analyzed dependently on brown adipose tissue activity
Measured: the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure
The potential associations between BAT activity and plasma nonesterified fatty acid concentrations
The plasma nonesterified fatty acid concentration was measured before and during cold exposure and analyzed dependently on brown adipose tissue activity
Measured: the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure
The potential associations between BAT activity and TSH concentrations
The TSH concentration was measured before and during cold exposure and analyzed dependently on brown adipose tissue activity
Measured: the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure
The potential associations between BAT activity and fT3 concentrations
The fT3 concentration was measured before and during cold exposure and analyzed dependently on brown adipose tissue activity
Measured: the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure
The potential associations between BAT activity and fT4 concentrations
The fT4 concentration was measured before and during cold exposure and analyzed dependently on brown adipose tissue activity
Measured: the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposu
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start1 Oct 2016
- Primary completion24 Feb 2018
- Study completion24 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdiposityStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katarzyna Maliszewska, PhD, Principal investigator, Medical University of Bialystok, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787952
- Sponsor's protocol ID
- UMB24/02/2021
- Status last verified
- Mar 2021
- First submitted
- 4 Mar 2021
- Last updated
- 10 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data maybe shared upon reasonable request and according with the Medical University of Bialystok condition.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Searching for the New Mechanisms That Activate Brow Fat Tissue
- ClinicalTrials.gov ID
- NCT04787952
- Acronym / sponsor ID
- UMB24/02/2021
- Conditions
- Adiposity, Metabolic Complication, Metabolic Disturbance, Healthy, Obesity, Diet Habit
- Keywords
- brown adipose tissue, obesity, diabetes type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 24 Feb 2018 (actual)
- Study completion
- 24 Feb 2018 (actual)
- First posted
- 9 Mar 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.
The general purpose of the study was to provide new information about the role of macronutrients intake, metabolomics, proteomics and microRNA on BAT activation.
The invesigator evaluated BAT activity and whole body energy consumption under cold stimulation in two gruops of healthy males aged 21-43 years old with normal BMI ( 19-25kg/m2) and in overweight/obese subjects.
Detailed description
In detail, the main objectives of this study was to measure the influence of biological molecules of such fields: genomics, transcriptomics metabolomics and protemics and its relationship on BAT activation. The investigator also evaluated the role of diet, macronutirnets intake and polyunsaturated fatty acids on BAT activity.
Study design:
- SCREENING VISIT:
- obtaining written informed consent from all subjects
- physical examination
- body composition analysis ( DXA + bioindepedance method inbody 720)
Laboratory analyses:
- Oral glucose tolerance test ( OGGT 75g)
- Morphology
- CRP
- Creatinine
- Urine analysis
- Lipids profile
- TSH
- ALT,AST
Dietary analysis All subjects fulfilled a 3-day food diary. Subjects were asked to compare the portion sizes with the colour photographs of each portion size, and to weigh food, if possible. The daily total energy, macronutrients, monounsaturated fatty acids (MUFA), polyunsaturated fatty acids (PUFA), omega-3, and omega-6 fatty acids intake were analysed.
- STUDY VISITS: Patients who met the inclusion criteria and passed the screening stage were invited for the first visit when PET / MRI after 2h of cold exposure was performed.
Subjects were studied in the morning, from approximately 8 a.m. to 12 a.m., after an overnight fast beginning at 10 p.m. the night before. At the beginning of the day on which the PET study was performed, a catheter was inserted in the subject's antecubital vein for a bolus injection of 18F-FDG. Another catheter was inserted in the antecubital vein of the contralateral arm and was used to obtain samples of venous blood.
The subjects rested in a supine position under thermoneutral conditions (22°C) for 1 hour and then participants were exposed to cooling for 2 hours. The water perfused blankets were used in the applied protocol of cooling. Blood samples were taken before as well as in 60th and 120th min of cooling. Subjects were cooled until shivering and then temperature is set slightly (1-2°C) above the temperature that causes the onset of shivering. Shivering were confirmed by visual inspection and by asking the subject each 15 min. After 2 hour the tracer 18F-FDG (4 MBq/kg ) was administered intravenously, and scanning was performed after the injection of tracer.
Skin temperatures were measured continually by means of electrode attached to skin below armpit.
During the cold exposure, whole body resting energy expenditure (REE) was assessed by a computed open-circuit indirect calorimetry method- based on the consumption of O2 and the production of CO2. The 30 min long measurements of resting oxygen uptake and resting carbon dioxide production were performed by a ventilated canopy Vmax Encore 29n System (Viasys HealthCare, Yorba Linda, CA, USA) at the baseline ( -30 min to 0 min) and every 30 min until 120 min of cold exposure.
During PET-MRI scanning blood samples were taken in 5', 10' 20' 30' 40' to check the activity of 18-FDG. After PET/MRI patient's urine was collected and analyzed for activity of tracer. Blood samples were taken for analysis before the cold exposure, at 60 min and 120 min during the cold exposure to evaluate:
Glucose, IL-6, Insulin, Free Fatty Acids (FFA), TSH, fT4,fT3, Irisin, Atrial natriuretic peptide (ANP), Brain natriuretic peptide (BNP), plasma nonesterified fatty acid (NEFA), DNA, Peripheral Blood Mononuclear Cell (PBMC) for microRNA isolation, metabolomics and proteomics analysis.
SUMMARY:
The goal of our study is to search for new mechanisms that stimulate activation of BAT. It is likely that individuals with different content and activity of the brown adipose will have different set of serum markers after exposure to cold. This will allow the identification of new biomarkers and to understand the molecular mechanisms responsible for the activation of the brown adipose tissue. The outcomes will enable to find new potential therapeutic and diagnostic applications given to the current obesity pandemic.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1= healthy subjects | – | Other: cold expossureInclusion criteria to the group 1 (healthy males) N=20: 1. BMI <25 kg/m2; 2. RR<140/90mmHg; 3. age 21-43 years 4. fasting glycemia <100mg/dl; 2h-OGTT <140mg/dl; 5. no chronic disease |
| Group 2 = overweight/obese subjects | – | Other: cold expossureInclusion criteria to the group 2 ( overweight/obese males ) N=20: 1. Blood pressure < 140/90 mmHg (well controlled by inh ACE; no beta-blockers) 2. No chronic disease 3. BMI > 25 <35kg/m² 4. fasting glycemia <100mg/dl; 2h-OGTT <140mg/dl; 5. age 21-43 years |
Who may qualify
- Ages
- 20 to 43 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study group comprised of 28 young, healthy, non - smoking Caucasian males, aged 21-42 years (mean age 26.75 ±5.11 years old), 16 with normal body weight (BMI < 25 kg/m2) and 12 obese/overweight (BMI > 25 kg/m2). Only participants without any comorbidities (e.g. hypo- and hyperthyroidis, asthma, cardiovascular disease, renal and liver failure, etc.) as well as without any medications (beta-blockers etc.) that could have impact on results, were enrolled to the study. Outside and shift workers have been excluded from the study as well.
Key inclusion criteria (10 listed)
- BMI <25 kg/m2;
- RR<140/90mmHg;
- age 20-30/40 years
- fasting glycemia <100mg/dl; 2h-OGTT <140mg/dl;
- no chronic disease
Key exclusion criteria (7 listed)
- Any drug use: beta-blokers, statins, glucocorticoids drugs, hypertension drugs;
- hypertension;
- cancer;
- hormonal disorders;
- Inflammation process
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 |
|---|---|---|
| cold expossuresubjects were exposed for the cold, to activate and diagnose potential brown tissue activity | Other | Group 1= healthy subjects, Group 2 = overweight/obese subjects |
Primary outcome
The potential associations between BAT activity and dietary intake
Time frame: 2016-2018
The relationship between BAT activity and dietary intake will be analyzed
The potential associations between BAT activity and metabolite profile
Time frame: the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure
The potential molecules will be identified by metabolomics approach and will be analyzed dependently on the brown tissue activity level
The potential associations between BAT activity and proteins profile
Time frame: the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure
The potential molecules will be identified by proteomics approach and will be analyzed dependently on the brown tissue activity level
The potential associations between BAT activity and transcriptome profile
Time frame: the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure
The potential molecules will be identified by transriptomics approach and will be analyzed dependently on the brown tissue activity level
13 secondary outcomes
The potential associations between BAT activity and Interleukin-6 concentrations
Time frame: the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure
The potential associations between BAT activity and energy expenditure
Time frame: at the baseline ( -30 min to 0 min) and every 30 min until 120 min of cold exposure
The potential associations between BAT activity and substrates utilization
Time frame: at the baseline ( -30 min to 0 min) and every 30 min until 120 min of cold exposure.
The potential associations between BAT activity and glucose concentrations
Time frame: he baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure
The potential associations between BAT activity and insulin concentrations
Time frame: the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure
The potential associations between BAT activity and FFA ( free fatty acids) concentrations
Time frame: the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure
The potential associations between BAT activity and irisin concentrations
Time frame: the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure
The potential associations between BAT activity and atrial natiuretic peptide concentrations
Time frame: the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure
The potential associations between BAT activity and brain natiuretic peptide concentrations
Time frame: the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure
The potential associations between BAT activity and plasma nonesterified fatty acid concentrations
Time frame: the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure
The potential associations between BAT activity and TSH concentrations
Time frame: the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure
The potential associations between BAT activity and fT3 concentrations
Time frame: the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure
The potential associations between BAT activity and fT4 concentrations
Time frame: the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposu
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 10 Mar 2021.
- Individual participant dataSharing planned: Yes. Data maybe shared upon reasonable request and according with the Medical University of Bialystok condition.
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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.
Katarzyna Maliszewska, PhD principal investigator
Medical University of Bialystok, Poland
Questions about this trial
What is this clinical trial studying?
An observational study of Adiposity and Metabolic Complication, run by Medical University of Bialystok.
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 10 inclusion and 7 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 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The potential associations between BAT activity and dietary intake (time frame: 2016-2018). The study lists 4 primary outcomes in all. 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 10 Mar 2021.