Central ObesityNCT04545320
Effectiveness of High-intensity Interval Training (HIIT) Versus Moderate-intensity Continuous Training (MICT) in Reducing Visceral Fat in Adults With Central Obesity
A study testing HIIT group and MICT group in people with Central Obesity, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Obesity is a major risk factor for cardiovascular disease and diabetes as well as all-cause mortality. The prevalence of obesity has continuously increased in most countries and has doubled in over 70 countries since 1980. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Central Obesity
- What is being tested?
- HIIT group and MICT group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2020to 31 Oct 2022
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18 - 60,
- Central obesity, defined as BMI ≥25 (obesity classification adopted by the Hong Kong Government) with waist circumference of ≥90 cm for men and ≥80 cm for women (abdominal obesity according to the International Diabetes Federation's Chinese ethnic-specific criterion),
- Males and females will be included to enhance generalizability.
Who cannot join
- ≥150 minutes moderate-intensity or ≥75 minutes vigorous-intensity exercise weekly,
- Regular HIIT or MICT (≥1 weekly) in the past 6 months,
- Medical history of cardiovascular disease, chronic pulmonary or kidney disease, heart failure, cancer, etc.,
- Somatic conditions that limit exercise participation (e.g., limb loss),
- Impaired mobility due to chronic diseases (e.g., chronic arthritis/osteoarthritis, neurological, musculoskeletal and autoimmune diseases),
- Daily smoking and drinking habit,
- Surgery, therapy or medication for obesity or weight loss in the past 6 months (e.g., gastric bypass, gastric band, sleeve gastrectomy, gastric reduction duodenal switch, and dietitian-prescribed dietary program).
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Li Ka Shing Faculty of Medicine, The University of Hong Kong
Hong Kong
About this study
Official title: Effectiveness of Once-a-week High-intensity Interval Training (HIIT) Versus Moderate-intensity Continuous Training (MICT) in Reducing Visceral Fat in Adults With Central Obesity, a Pilot Randomized Controlled Trial.
Obesity is a major risk factor for cardiovascular disease and diabetes as well as all-cause mortality. The prevalence of obesity has continuously increased in most countries and has doubled in over 70 countries since 1980. The World Health Organization (WHO) estimated in 2014 that ~600 million (13%) adults were obese and ~1.9 billion (39%) were overweight worldwide. Notably, United States and China have the highest numbers of obese adults. According to a national survey in China in 2014 conducted among 146,703 Chinese adults aged 20-59, the prevalence of obesity was 13%, central obesity was 25% and overweight was 41%. In Hong Kong, the Behavioural Risk Factor Survey conducted by the Government in 2016 found 39% of adults were classified as overweight or obese, of which 21% were obese. The prevalence of central obesity has also risen steadily since 1999 in America. By 2030 is projected to reach 55.6% in men, 80.0% in women, 47.6% among girls and 38.9% among boys in the United States. Overweight, obesity and central obesity are now already pandemic public health issues causing heavy burden on healthcare system. Nowadays, lifestyle modification interventions still remain as the primary strategy to manage obesity and obesity-related complications, among which exercise is low-cost and effective. Substantial evidences have demonstrated effectiveness of HIIT and MICT in reducing body adiposity and improving body Anthropometry. However, studies have also pointed out "lack of time" is one of the major barriers preventing patients from exercise participation. Therefore, studies have put focus on low-frequency or low-volume exercise in improving health to reduce time commitment and increase exercise adherence. Among substantial evidence, our recent study demonstrated once-a-week HIIT is effectively in improving body composition. The effectiveness of low-frequency exercise in reducing visceral fat has also been explored. However, a recent meta-analysis showed low-frequency exercise is not effective in reducing visceral fat. Notably, the authors pointed out most of studies included in the meta-analysis adopted cycling exercise modality and they suggested walking or running exercise which recruits more body muscles may exert better results. In this study, we propose to adopt walking exercise modality to fill the research gap identified by the meta-analysis. Also, no study has compared the effectiveness of low-frequency HIIT and MICT in reducing visceral fat determined by magnetic resonance imaging (MRI) previously.
Study aim: to examine the effectiveness of once-a-week high-intensity interval training (HIIT) versus moderate-intensity continuous training (MICT) in reducing visceral fat in adults with central obesity
- Conditions
- Central Obesity
- Being tested
- Usual care control group, HIIT group, MICT group
- Keywords
- Central Obesity, Visceral Fat, HIIT, MICT
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual care control groupBehavioural
Health education
HIIT groupBehavioural
Once-a-week HIIT
MICT groupBehavioural
Once-a-week MICT
| Study group | Role | What they receive |
|---|---|---|
| Usual care control group | Placebo comparator | Subjects in the usual care control group will receive a health education program to provide the usual care information. This program will include 3-month biweekly sessions (70 minutes each session, total 6 sessions) for obesity-related health briefing, dietary caloric restriction advice, lifestyle counselling/consultation and stretching exercise. Receives: Behavioral: Usual care control group |
| HIIT group | Experimental | A 3-month intervention of HIIT will be given to participants allocated to this group. The once-a-week HIIT will be performed in small groups on treadmills supervised by certified athletic coaches. Subjects will perform brisk walking for four 4-min bouts at 85%-95% maximal heart rate (HRmax) with a 3-min active recovery walk at 50%-70% HRmax between each session. There will be a 5-min warm-up and cool-down in each exercise session. The duration of each exercise session will be 35 minutes. Heart rate will be continuously monitored during training using Polar M300 with OH1 optical heart rate sensor. Receives: Behavioral: HIIT group |
| MICT group | Experimental | A 3-month intervention of MICT will be given to participants allocated to this group. The once-a-week MICT will be performed in small groups on treadmills supervised by certified athletic coaches. Subjects will perform mild walking exercise for ~47 minutes at an intensity of 65-75% HRmax. This exercise volume matches the HIIT volume. Heart rate will be continuously monitored during training using Polar M300 with OH1 optical heart rate sensor. Receives: Behavioral: MICT group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visceral fat
The amounts of visceral fat (VAT) at the abdominal region will be assessed by a 1.5-Teala whole-body scanner. A breath-hold localizer scan will be performed prior to the MRI scan. T1-weighted in-phase images will be obtained by fast spoiled gradient-echo sequences during suspended end-expiration. The VAT and between the thoracic diaphragm and the upper broader of the first sacral vertebra will be manually marked on each transverse image to calculate the volume of abdominal VAT.
Measured: 3-month follow-up
Secondary outcomes (19)
Subcutaneous fat
The amounts of subcutaneous fat (SAT) at the abdominal region will be assessed by a 1.5-Teala whole-body scanner. A breath-hold localizer scan will be performed prior to the MRI scan. T1-weighted in-phase images will be obtained by fast spoiled gradient-echo sequences during suspended end-expiration. The SAT between the thoracic diaphragm and the upper broader of the first sacral vertebra will be manually marked on each transverse image to calculate the volume of abdominal SAT.
Measured: 3-month follow-up
Body fat mass
Total body fat mass will be determined using a full body dual-energy X-ray absorptiometry (DXA) scanner (Explorer S/N 91075, Hologic Inc., Waltham, USA). A trained technician who is blinded to the group allocation will perform the tests and analyze the results.
Measured: 3-month follow-up
Body fat percentage
Total body fat percentage will be determined using a full body dual-energy X-ray absorptiometry (DXA) scanner (Explorer S/N 91075, Hologic Inc., Waltham, USA). A trained technician who is blinded to the group allocation will perform the tests and analyze the results.
Measured: 3-month follow-up
Body Mass Index
BMI will be determined by the equation BMI (kg/m2) = bodyweight/height^2. A calibrated electronic balance(UC-321,A\&D Weighing, Australia, 150 kg capacity, ± 0.05 kg accuracy) and a stadiometer (Seva 231, Seca, Germany, 205 cm limit, ± 0.05 cm accuracy; ) will be used for the measurements.
Measured: 3-month follow-up
Waist Circumference 1
Waist circumference will be measured on bare skin midway between the lowest rib and the superior border of the iliac crest using an inelastic measuring tape (Seca 201, Seca, Germany) to the nearest 0.1 cm following the WHO guideline. Measurement will be performed at the end of normal expiration.
Measured: 3-month follow-up
Waist Circumference 2
Waist circumference will be measured on bare skin following the National Institutes of Health (NIH) guideline method (the superior border of the iliac crest)using an inelastic measuring tape (Seca 201, Seca, Germany) to the nearest 0.1 cm. Measurement will be performed at the end of normal expiration.
Measured: 3-month follow-up
Cardiorespiratory fitness
A maximal exercise test adopting the modified Bruce protocol will be be conducted to determine the maximal oxygen uptake (VO2max) of the subjects. The test will be conducted on a calibrated motor-driven treadmill with continuous metabolic VO2 measurement using a COSMED Quark CPET gas analysis system.
Measured: 3-month follow-up
Bone Mineral Density
Bone mineral density will be simultaneously determined during the DXA scan for total body fat mass.
Measured: 3-month follow-up
Lean Mass
Lean mass will be simultaneously determined during the DXA scan for total body fat mass.
Measured: 3-month follow-up
Health-related Quality of Life
The validated Chinese version 12-item short form survey measures health-related quality of life covering physical functioning, emotional and mental health, bodily pain, general health, vitality, and social functioning. A higher overall score indicates better quality of life.
Measured: 3-month follow-up
Adherence
Class attendance will be analysed to indicate adherence to the interventions.
Measured: 3-month follow-up
Adverse Events
Adverse events will be closely monitored regularly by athletic coaches and research personnel, and by subjects' voluntary reports. Adverse events will be recorded as a secondary outcome.
Measured: 3-month follow-up
Medication
Detailed information (e.g., drug name, type, dose and daily frequency) on the use of dyslipidemic and hypertensive medications will be recorded at baseline. Subjects altering the dosage of medications after consultation with their physician over the study period will also be recorded as a secondary outcome. The lowest recommended dose (LRD) for 7 days will be used for the analysis.
Measured: 3-month follow-up
Habitual Physical Activity
Actigraph activity monitor (wGT3X-BT, Actigraph, USA) worn at the wrist region for 24 h over 7 consecutive days will be used to objectively determine habitual daily physical movement/activities.
Measured: 3-month follow-up
Dietary Intake
Habitual dietary intake will be assessed by 3-day food diary using an electronic scale (KD-400, Tanita, Japan)to determine the daily caloric intake and the relative proportions of macronutrients (carbohydrate, fat, and protein).
Measured: 3-month follow-up
Blood pressure
Blood pressure will be obtained at the same day with blood collection. Subjects will visit our laboratory in the morning after 10 hours of overnight fasting in order to retrain from consuming caffeine, alcohol, and blood pressure drugs at least 10 hours before the assessment. After 10 minutes of seated rest, blood pressure will be measured on the left arm using a sphygmomanometer. Systolic and diastolic blood pressure and mean arterial pressure will be obtained over the brachial artery region with the arm supported at the heart level using an appropriately sized cuff. Three measurements will be taken with a one-minute interval, and the average value will be recorded for analysis.
Measured: 3-month follow-up
Hip circumference
Hip circumference will be be taken on bare skin around the widest portion of the buttocks using an inelastic measuring tape (Seca 201, Seca, Germany) to the nearest 0.1 cm and the tape should be placed parallel to the floor.
Measured: 3-month follow-up
Self-report habitual physical activity
Self-report habitual physical activity will be measured by International Physical Activity Questionnaire (IPAQ). Higher scores indicate higher level of physical activity.
Measured: 3-month follow-up
Enjoyment
Enjoyment towards exercise will be quantitatively measured by the Physical Activity Enjoyment Scale. This Chinese scale has an overall score from 18 to 126. While a higher score indicates higher level of enjoyment towards the exercise.
Measured: 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2020
- Study start1 Sep 2020
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Why it stopped: No participants were enrolled in this study due to the COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central ObesityStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Parco M. Siu, PhD, The University of Hong Kong
- Investigators
- Ming Fai Parco Siu, PhD, Principal investigator, Li Ka Shing Faculty of Medicine, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545320
- Sponsor's protocol ID
- 303005-RF008-CB
- Status last verified
- Nov 2022
- First submitted
- 3 Sep 2020
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data of individual participants that underlie the results reported in this trial, after de-identification including text, tables, figures, and appendices, as well as study protocol and statistical analysis plan, will be shared after 3 months of study publication. Data will be shared with researchers who provide a methodologically sound proposal for academic purposes. Proposals should be directed to pmsiu@hku.hk to gain access and for the data requests, a data-access agreement needs to be signed.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Once-a-week High-intensity Interval Training (HIIT) Versus Moderate-intensity Continuous Training (MICT) in Reducing Visceral Fat in Adults With Central Obesity, a Pilot Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04545320
- Acronym / sponsor ID
- 303005-RF008-CB
- Conditions
- Central Obesity
- Keywords
- Central Obesity, Visceral Fat, HIIT, MICT
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants were enrolled in this study due to the COVID-19 pandemic.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 11 Sep 2020 (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.
Obesity is a major risk factor for cardiovascular disease and diabetes as well as all-cause mortality. The prevalence of obesity has continuously increased in most countries and has doubled in over 70 countries since 1980. The World Health Organization (WHO) estimated in 2014 that ~600 million (13%) adults were obese and ~1.9 billion (39%) were overweight worldwide. Notably, United States and China have the highest numbers of obese adults. According to a national survey in China in 2014 conducted among 146,703 Chinese adults aged 20-59, the prevalence of obesity was 13%, central obesity was 25% and overweight was 41%. In Hong Kong, the Behavioural Risk Factor Survey conducted by the Government in 2016 found 39% of adults were classified as overweight or obese, of which 21% were obese. The prevalence of central obesity has also risen steadily since 1999 in America. By 2030 is projected to reach 55.6% in men, 80.0% in women, 47.6% among girls and 38.9% among boys in the United States. Overweight, obesity and central obesity are now already pandemic public health issues causing heavy burden on healthcare system. Nowadays, lifestyle modification interventions still remain as the primary strategy to manage obesity and obesity-related complications, among which exercise is low-cost and effective. Substantial evidences have demonstrated effectiveness of HIIT and MICT in reducing body adiposity and improving body Anthropometry. However, studies have also pointed out "lack of time" is one of the major barriers preventing patients from exercise participation. Therefore, studies have put focus on low-frequency or low-volume exercise in improving health to reduce time commitment and increase exercise adherence. Among substantial evidence, our recent study demonstrated once-a-week HIIT is effectively in improving body composition. The effectiveness of low-frequency exercise in reducing visceral fat has also been explored. However, a recent meta-analysis showed low-frequency exercise is not effective in reducing visceral fat. Notably, the authors pointed out most of studies included in the meta-analysis adopted cycling exercise modality and they suggested walking or running exercise which recruits more body muscles may exert better results. In this study, we propose to adopt walking exercise modality to fill the research gap identified by the meta-analysis. Also, no study has compared the effectiveness of low-frequency HIIT and MICT in reducing visceral fat determined by magnetic resonance imaging (MRI) previously.
Study aim: to examine the effectiveness of once-a-week high-intensity interval training (HIIT) versus moderate-intensity continuous training (MICT) in reducing visceral fat in adults with central obesity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care control group | Placebo comparator | Behavioral: Usual care control groupSubjects in the usual care control group will receive a health education program to provide the usual care information. This program will include 3-month biweekly sessions (70 minutes each session, total 6 sessions) for obesity-related health briefing, dietary caloric restriction advice, lifestyle counselling/consultation and stretching exercise. |
| HIIT group | Experimental | Behavioral: HIIT groupA 3-month intervention of HIIT will be given to participants allocated to this group. The once-a-week HIIT will be performed in small groups on treadmills supervised by certified athletic coaches. Subjects will perform brisk walking for four 4-min bouts at 85%-95% maximal heart rate (HRmax) with a 3-min active recovery walk at 50%-70% HRmax between each session. There will be a 5-min warm-up and cool-down in each exercise session. The duration of each exercise session will be 35 minutes. Heart rate will be continuously monitored during training using Polar M300 with OH1 optical heart rate sensor. |
| MICT group | Experimental | Behavioral: MICT groupA 3-month intervention of MICT will be given to participants allocated to this group. The once-a-week MICT will be performed in small groups on treadmills supervised by certified athletic coaches. Subjects will perform mild walking exercise for ~47 minutes at an intensity of 65-75% HRmax. This exercise volume matches the HIIT volume. Heart rate will be continuously monitored during training using Polar M300 with OH1 optical heart rate sensor. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults aged 18 - 60,
- Central obesity, defined as BMI ≥25 (obesity classification adopted by the Hong Kong Government) with waist circumference of ≥90 cm for men and ≥80 cm for women (abdominal obesity according to the International Diabetes Federation's Chinese ethnic-specific criterion),
- Males and females will be included to enhance generalizability.
Key exclusion criteria (7 listed)
- ≥150 minutes moderate-intensity or ≥75 minutes vigorous-intensity exercise weekly,
- Regular HIIT or MICT (≥1 weekly) in the past 6 months,
- Medical history of cardiovascular disease, chronic pulmonary or kidney disease, heart failure, cancer, etc.,
- Somatic conditions that limit exercise participation (e.g., limb loss),
- Impaired mobility due to chronic diseases (e.g., chronic arthritis/osteoarthritis, neurological, musculoskeletal and autoimmune 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 |
|---|---|---|
| Usual care control groupHealth education | Behavioural | Usual care control group |
| HIIT groupOnce-a-week HIIT | Behavioural | HIIT group |
| MICT groupOnce-a-week MICT | Behavioural | MICT group |
Primary outcome
Visceral fat
Time frame: 3-month follow-up
The amounts of visceral fat (VAT) at the abdominal region will be assessed by a 1.5-Teala whole-body scanner. A breath-hold localizer scan will be performed prior to the MRI scan. T1-weighted in-phase images will be obtained by fast spoiled gradient-echo sequences during suspended end-expiration. The VAT and between the thoracic diaphragm and the upper broader of the first sacral vertebra will be manually marked on each transverse image to calculate the volume of abdominal VAT.
19 secondary outcomes
Subcutaneous fat
Time frame: 3-month follow-up
Body fat mass
Time frame: 3-month follow-up
Body fat percentage
Time frame: 3-month follow-up
Body Mass Index
Time frame: 3-month follow-up
Waist Circumference 1
Time frame: 3-month follow-up
Waist Circumference 2
Time frame: 3-month follow-up
Cardiorespiratory fitness
Time frame: 3-month follow-up
Bone Mineral Density
Time frame: 3-month follow-up
Lean Mass
Time frame: 3-month follow-up
Health-related Quality of Life
Time frame: 3-month follow-up
Adherence
Time frame: 3-month follow-up
Adverse Events
Time frame: 3-month follow-up
Medication
Time frame: 3-month follow-up
Habitual Physical Activity
Time frame: 3-month follow-up
Dietary Intake
Time frame: 3-month follow-up
Blood pressure
Time frame: 3-month follow-up
Hip circumference
Time frame: 3-month follow-up
Self-report habitual physical activity
Time frame: 3-month follow-up
Enjoyment
Time frame: 3-month follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Individual participant dataSharing planned: Yes. The data of individual participants that underlie the results reported in this trial, after de-identification including text, tables, figures, and appendices, as well as study protocol and statistical analysis plan, will be shared after 3 months of study publication. Data will be shared with researchers who provide a methodologically sound proposal for academic purposes. Proposals should be directed to pmsiu@hku.hk to gain access and for the data requests, a data-access agreement needs to be signed.
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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.
Ming Fai Parco Siu, PhD principal investigator
Li Ka Shing Faculty of Medicine, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT group and MICT group in people with Central Obesity, run by The University of Hong Kong at 1 site in Hong Kong.
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 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: withdrawn, as of the sponsor's last update on 4 Nov 2022. 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Visceral fat (time frame: 3-month follow-up). 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 4 Nov 2022.