ObesityNCT05007171
Changes in Anthropometric, Biochemical and DNA Damage Parameters After 3-weeks VLCD in Severely Obese Patients
A study testing Very low calorie diet in people with Obesity and Weight Loss, run by Special Hospital for Extended Treatment of Duga Resa at 1 site in Croatia.
Trial summary
Obesity manifest with inflammation, hyperglycaemia and dyslipidaemia. These conditions disturb redox system by generating excessive reactive oxygen species (ROS) and causing oxidative stress (OS) leading to DNA damage. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Weight Loss, DNA Damage
- What is being tested?
- Very low calorie diet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCroatia
- Study dates
- 14 Jun 2019to 9 Mar 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- body mass index ≥ 35 kg/m2
Who cannot join
- pregnancy
- actual tumor diseases
- recent diagnostic or treatment exposures to ionizing radiation in the period of one year
- individuals not willing to stay 3 weeks under supervision under full 24 h surveillance from the medical stuff
Trial locations and contacts
1 site in 1 country.
Croatia1 site
Special Hospital for Extended Treatment of Duga Resa
Duga Resa, City of Zagreb, 47250
About this study
Official title: Changes in Anthropometric, Biochemical and DNA Damage Parameters After 3-weeks-567-kcal VLCD in Severely Obese Patients With BMI ≥ 35kg/m2
Obesity manifest with inflammation, hyperglycaemia and dyslipidaemia. These conditions disturb redox system by generating excessive reactive oxygen species (ROS) and causing oxidative stress (OS) leading to DNA damage. Very low calorie diet (VLCD) have rapid positive effect on weight loss, glucose homeostasis, inflammation and OS. The aim of study is to test the influence of 3-weeks VLCD on anthropometric, biochemical and genomic parameters in class II and III obesity patients.
Read the detailed description
Obesity is a chronic disease associated with chronic inflammation, insulin resistance, dyslipidemia, oxidative stress and increased risk for type 2 diabetes, cardiovascular disease, stroke and multiple cancer types. Oxidative stress can lead to base lesions of DNA which could be detected with alkine comet assay and its version with use of formamidopyrimidine DNA glycosylase-endonuclease enzyme in fresh or frozen small volume samples. Dietary caloric restriction has beneficial effects on insulin sensitivity, inflammation, oxidative stress and DNA repair. Very low calorie diet (VLCD) data are scarce, especially on the changing levels of DNA damage.This study will assess the effect of a three-week VLCD used in Special Hospital for extended treatment of Duga Resa in individuals with BMI ≥ 35kg/m2 on the level of primary and oxidative DNA damage as well as body composition and biochemical parameters.
- Conditions
- Obesity, Weight Loss, DNA Damage
- Being tested
- Very low calorie diet
- Keywords
- Obesity, Very low calorie diet, Alkine comet assay, FPG oxidative comet assay, DNA damage
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very low calorie dietDevice
During 3 weeks in hospital patients will eat prepared very low calorie diet composed of 50-60% complex carbohydrates with low carbo-glycemic index, 20-25% proteins and 25-30% fat
| Study group | Role | What they receive |
|---|---|---|
| Very low calorie diet | Experimental | Use of very low calorie diet in hospital for 3 weeks Receives: Device: Very low calorie diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes in the body mass index
Body mass index (kg/m2) is calculated by using measured body weight (kg) with measured body height (m)
Measured: Baseline, after 3 weeks of VLCD
The changes in the body fat mass
Body fat mass (kg) assessed with bioelectrical impedance method
Measured: Baseline, after 3 weeks of VLCD
The changes in the skeletal muscle mass
Skeletal muscle mass (kg) assessed with bioelectrical impedance method
Measured: Baseline, after 3 weeks of VLCD
The changes in the percent body fat
Percent body fat (%) assessed with bioelectrical impedance method
Measured: Baseline, after 3 weeks of VLCD
The changes in fasting glucose concentration
Concentration of glucose (mmol/L)
Measured: Baseline, after 3 weeks of VLCD
The changes in urea concentration
Concentration of urea (mmol/L)
Measured: Baseline, after 3 weeks of VLCD
The changes in insulin concentration
Concentration of insulin (mIU/L)
Measured: Baseline, after 3 weeks of VLCD
The changes in HOMA index
HOMA index is calculated according to the formula: glucose (mmol/L) x insulin (mIU/L)/22.5
Measured: Baseline, after 3 weeks of VLCD
The changes in lipid profile
Concentrations of triglycerides (mmo/L), LDL (mmol/L), HDL (mmol/L) cholesterol (mmol/L)
Measured: Baseline, after 3 weeks of VLCD
The changes in inflammation parameters
Concentration of C-reactive protein (mg/L)
Measured: Baseline, after 3 weeks of VLCD
The changes in inflammation parameters
Concentration of total white blood cell count
Measured: Baseline, after 3 weeks of VLCD
Secondary outcomes (3)
The changes in DNA damage assessed with alkaline comet assay
Values for alkaline comet assay in μm for tale length
Measured: Baseline, after 3 weeks of VLCD
The changes in DNA damage assessed with alkaline comet assay
Values for alkaline comet assay in % for tale intensity
Measured: Baseline, after 3 weeks of VLCD
The changes in oxidative DNA damage assessed with FPG comet assay
Values for FPG comet assay in % for tale intensity
Measured: Baseline, after 3 weeks of VLCD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start14 Jun 2019
- Primary completion9 Mar 2020
- Study completion9 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Special Hospital for Extended Treatment of Duga Resa
- Sponsor type
- Other government
- Collaborators
- Institute for Medical Research and Occupational Health, University of Zagreb
- Responsible party
- Sponsor
- Investigators
- Mirta Milic, PhD, Principal investigator, Institute for Medical Research and Occupational Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007171
- Sponsor's protocol ID
- DNAa3WVLCDiBMI-35/22
- Status last verified
- Aug 2021
- First submitted
- 16 Jul 2021
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Usman M, Volpi EV. DNA damage in obesity: Initiator, promoter and predictor of cancer. Mutat Res Rev Mutat Res. 2018 Oct-Dec;778:23-37. doi: 10.1016/j.mrrev.2018.08.002. Epub 2018 Aug 17.
PubMed 30454680Himbert C, Thompson H, Ulrich CM. Effects of Intentional Weight Loss on Markers of Oxidative Stress, DNA Repair and Telomere Length - a Systematic Review. Obes Facts. 2017;10(6):648-665. doi: 10.1159/000479972. Epub 2017 Dec 14.
PubMed 29237161Wlodarczyk M, Nowicka G. Obesity, DNA Damage, and Development of Obesity-Related Diseases. Int J Mol Sci. 2019 Mar 6;20(5):1146. doi: 10.3390/ijms20051146.
PubMed 30845725Hart RW, Dixit R, Seng J, Turturro A, Leakey JE, Feuers R, Duffy P, Buffington C, Cowan G, Lewis S, Pipkin J, Li SY. Adaptive role of caloric intake on the degenerative disease processes. Toxicol Sci. 1999 Dec;52(2 Suppl):3-12. doi: 10.1093/toxsci/52.2.3.
PubMed 10630584Heydari AR, Unnikrishnan A, Lucente LV, Richardson A. Caloric restriction and genomic stability. Nucleic Acids Res. 2007;35(22):7485-96. doi: 10.1093/nar/gkm860. Epub 2007 Oct 16.
PubMed 17942423Setayesh T, Nersesyan A, Misik M, Ferk F, Langie S, Andrade VM, Haslberger A, Knasmuller S. Impact of obesity and overweight on DNA stability: Few facts and many hypotheses. Mutat Res Rev Mutat Res. 2018 Jul-Sep;777:64-91. doi: 10.1016/j.mrrev.2018.07.001. Epub 2018 Jul 11.
PubMed 30115431Setayesh T, Misik M, Langie SAS, Godschalk R, Waldherr M, Bauer T, Leitner S, Bichler C, Prager G, Krupitza G, Haslberger A, Knasmuller S. Impact of Weight Loss Strategies on Obesity-Induced DNA Damage. Mol Nutr Food Res. 2019 Sep;63(17):e1900045. doi: 10.1002/mnfr.201900045. Epub 2019 Jun 14.
PubMed 31141317Harper C, Maher J, Grunseit A, Seimon RV, Sainsbury A. Experiences of using very low energy diets for weight loss by people with overweight or obesity: a review of qualitative research. Obes Rev. 2018 Oct;19(10):1412-1423. doi: 10.1111/obr.12715. Epub 2018 Aug 24.
PubMed 30144269Parretti HM, Jebb SA, Johns DJ, Lewis AL, Christian-Brown AM, Aveyard P. Clinical effectiveness of very-low-energy diets in the management of weight loss: a systematic review and meta-analysis of randomized controlled trials. Obes Rev. 2016 Mar;17(3):225-34. doi: 10.1111/obr.12366. Epub 2016 Jan 18.
PubMed 26775902Milic M, Ozvald I, Vinkovic Vrcek I, Vucic Lovrencic M, Orescanin V, Bonassi S, Del Castillo ER. Alkaline comet assay results on fresh and one-year frozen whole blood in small volume without cryo-protection in a group of people with different health status. Mutat Res Genet Toxicol Environ Mutagen. 2019 Jul;843:3-10. doi: 10.1016/j.mrgentox.2019.03.009. Epub 2019 Mar 28.
PubMed 31421735Milic M, Kisan M, Rogulj D, Radman M, Lovrencic MV, Konjevoda P, Domijan AM. Level of primary DNA damage in the early stage of metabolic syndrome. Mutat Res Genet Toxicol Environ Mutagen. 2013 Dec 12;758(1-2):1-5. doi: 10.1016/j.mrgentox.2013.07.013. Epub 2013 Sep 27.
PubMed 24076402Rogulj D, Konjevoda P, Milic M, Mladinic M, Domijan AM. Fatty liver index as an indicator of metabolic syndrome. Clin Biochem. 2012 Jan;45(1-2):68-71. doi: 10.1016/j.clinbiochem.2011.10.014. Epub 2011 Oct 26.
PubMed 22056738Langie SA, Azqueta A, Collins AR. The comet assay: past, present, and future. Front Genet. 2015 Aug 13;6:266. doi: 10.3389/fgene.2015.00266. eCollection 2015. No abstract available.
PubMed 26322077Mulligan AA, Luben RN, Bhaniani A, Parry-Smith DJ, O'Connor L, Khawaja AP, Forouhi NG, Khaw KT; EPIC-Norfolk FFQ Study. A new tool for converting food frequency questionnaire data into nutrient and food group values: FETA research methods and availability. BMJ Open. 2014 Mar 27;4(3):e004503. doi: 10.1136/bmjopen-2013-004503.
PubMed 24674997Heilbronn LK, de Jonge L, Frisard MI, DeLany JP, Larson-Meyer DE, Rood J, Nguyen T, Martin CK, Volaufova J, Most MM, Greenway FL, Smith SR, Deutsch WA, Williamson DA, Ravussin E; Pennington CALERIE Team. Effect of 6-month calorie restriction on biomarkers of longevity, metabolic adaptation, and oxidative stress in overweight individuals: a randomized controlled trial. JAMA. 2006 Apr 5;295(13):1539-48. doi: 10.1001/jama.295.13.1539.
PubMed 16595757
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Anthropometric, Biochemical and DNA Damage Parameters After 3-weeks-567-kcal VLCD in Severely Obese Patients With BMI ≥ 35kg/m2
- ClinicalTrials.gov ID
- NCT05007171
- Acronym / sponsor ID
- DNAa3WVLCDiBMI-35/22
- Conditions
- Obesity, Weight Loss, DNA Damage
- Keywords
- Obesity, Very low calorie diet, Alkine comet assay, FPG oxidative comet assay, DNA damage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Special Hospital for Extended Treatment of Duga ResaOther government
- Collaborators
- Institute for Medical Research and Occupational Health, University of Zagreb
- Study start
- 14 Jun 2019 (actual)
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 16 Aug 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.
Obesity manifest with inflammation, hyperglycaemia and dyslipidaemia. These conditions disturb redox system by generating excessive reactive oxygen species (ROS) and causing oxidative stress (OS) leading to DNA damage. Very low calorie diet (VLCD) have rapid positive effect on weight loss, glucose homeostasis, inflammation and OS. The aim of study is to test the influence of 3-weeks VLCD on anthropometric, biochemical and genomic parameters in class II and III obesity patients.
Detailed description
Obesity is a chronic disease associated with chronic inflammation, insulin resistance, dyslipidemia, oxidative stress and increased risk for type 2 diabetes, cardiovascular disease, stroke and multiple cancer types. Oxidative stress can lead to base lesions of DNA which could be detected with alkine comet assay and its version with use of formamidopyrimidine DNA glycosylase-endonuclease enzyme in fresh or frozen small volume samples. Dietary caloric restriction has beneficial effects on insulin sensitivity, inflammation, oxidative stress and DNA repair. Very low calorie diet (VLCD) data are scarce, especially on the changing levels of DNA damage.This study will assess the effect of a three-week VLCD used in Special Hospital for extended treatment of Duga Resa in individuals with BMI ≥ 35kg/m2 on the level of primary and oxidative DNA damage as well as body composition and biochemical parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Very low calorie diet | Experimental | Device: Very low calorie dietUse of very low calorie diet in hospital for 3 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- body mass index ≥ 35 kg/m2
Key exclusion criteria (4 listed)
- pregnancy
- actual tumor diseases
- recent diagnostic or treatment exposures to ionizing radiation in the period of one year
- individuals not willing to stay 3 weeks under supervision under full 24 h surveillance from the medical stuff
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 |
|---|---|---|
| Very low calorie dietDuring 3 weeks in hospital patients will eat prepared very low calorie diet composed of 50-60% complex carbohydrates with low carbo-glycemic index, 20-25% proteins and 25-30% fat | Device | Very low calorie diet |
Primary outcome
The changes in the body mass index
Time frame: Baseline, after 3 weeks of VLCD
Body mass index (kg/m2) is calculated by using measured body weight (kg) with measured body height (m)
The changes in the body fat mass
Time frame: Baseline, after 3 weeks of VLCD
Body fat mass (kg) assessed with bioelectrical impedance method
The changes in the skeletal muscle mass
Time frame: Baseline, after 3 weeks of VLCD
Skeletal muscle mass (kg) assessed with bioelectrical impedance method
The changes in the percent body fat
Time frame: Baseline, after 3 weeks of VLCD
Percent body fat (%) assessed with bioelectrical impedance method
The changes in fasting glucose concentration
Time frame: Baseline, after 3 weeks of VLCD
Concentration of glucose (mmol/L)
The changes in urea concentration
Time frame: Baseline, after 3 weeks of VLCD
Concentration of urea (mmol/L)
The changes in insulin concentration
Time frame: Baseline, after 3 weeks of VLCD
Concentration of insulin (mIU/L)
The changes in HOMA index
Time frame: Baseline, after 3 weeks of VLCD
HOMA index is calculated according to the formula: glucose (mmol/L) x insulin (mIU/L)/22.5
The changes in lipid profile
Time frame: Baseline, after 3 weeks of VLCD
Concentrations of triglycerides (mmo/L), LDL (mmol/L), HDL (mmol/L) cholesterol (mmol/L)
The changes in inflammation parameters
Time frame: Baseline, after 3 weeks of VLCD
Concentration of C-reactive protein (mg/L)
The changes in inflammation parameters
Time frame: Baseline, after 3 weeks of VLCD
Concentration of total white blood cell count
3 secondary outcomes
The changes in DNA damage assessed with alkaline comet assay
Time frame: Baseline, after 3 weeks of VLCD
The changes in DNA damage assessed with alkaline comet assay
Time frame: Baseline, after 3 weeks of VLCD
The changes in oxidative DNA damage assessed with FPG comet assay
Time frame: Baseline, after 3 weeks of VLCD
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 16 Aug 2021.
- Background: PubMed 30454680Usman M, Volpi EV. DNA damage in obesity: Initiator, promoter and predictor of cancer. Mutat Res Rev Mutat Res. 2018 Oct-Dec;778:23-37. doi: 10.1016/j.mrrev.2018.08.002. Epub 2018 Aug 17.
- Background: PubMed 29237161Himbert C, Thompson H, Ulrich CM. Effects of Intentional Weight Loss on Markers of Oxidative Stress, DNA Repair and Telomere Length - a Systematic Review. Obes Facts. 2017;10(6):648-665. doi: 10.1159/000479972. Epub 2017 Dec 14.
- Background: PubMed 30845725Wlodarczyk M, Nowicka G. Obesity, DNA Damage, and Development of Obesity-Related Diseases. Int J Mol Sci. 2019 Mar 6;20(5):1146. doi: 10.3390/ijms20051146.
- Background: PubMed 10630584Hart RW, Dixit R, Seng J, Turturro A, Leakey JE, Feuers R, Duffy P, Buffington C, Cowan G, Lewis S, Pipkin J, Li SY. Adaptive role of caloric intake on the degenerative disease processes. Toxicol Sci. 1999 Dec;52(2 Suppl):3-12. doi: 10.1093/toxsci/52.2.3.
- Background: PubMed 17942423Heydari AR, Unnikrishnan A, Lucente LV, Richardson A. Caloric restriction and genomic stability. Nucleic Acids Res. 2007;35(22):7485-96. doi: 10.1093/nar/gkm860. Epub 2007 Oct 16.
- Background: PubMed 30115431Setayesh T, Nersesyan A, Misik M, Ferk F, Langie S, Andrade VM, Haslberger A, Knasmuller S. Impact of obesity and overweight on DNA stability: Few facts and many hypotheses. Mutat Res Rev Mutat Res. 2018 Jul-Sep;777:64-91. doi: 10.1016/j.mrrev.2018.07.001. Epub 2018 Jul 11.
- Background: PubMed 31141317Setayesh T, Misik M, Langie SAS, Godschalk R, Waldherr M, Bauer T, Leitner S, Bichler C, Prager G, Krupitza G, Haslberger A, Knasmuller S. Impact of Weight Loss Strategies on Obesity-Induced DNA Damage. Mol Nutr Food Res. 2019 Sep;63(17):e1900045. doi: 10.1002/mnfr.201900045. Epub 2019 Jun 14.
- Background: PubMed 30144269Harper C, Maher J, Grunseit A, Seimon RV, Sainsbury A. Experiences of using very low energy diets for weight loss by people with overweight or obesity: a review of qualitative research. Obes Rev. 2018 Oct;19(10):1412-1423. doi: 10.1111/obr.12715. Epub 2018 Aug 24.
- Background: PubMed 26775902Parretti HM, Jebb SA, Johns DJ, Lewis AL, Christian-Brown AM, Aveyard P. Clinical effectiveness of very-low-energy diets in the management of weight loss: a systematic review and meta-analysis of randomized controlled trials. Obes Rev. 2016 Mar;17(3):225-34. doi: 10.1111/obr.12366. Epub 2016 Jan 18.
- Background: PubMed 31421735Milic M, Ozvald I, Vinkovic Vrcek I, Vucic Lovrencic M, Orescanin V, Bonassi S, Del Castillo ER. Alkaline comet assay results on fresh and one-year frozen whole blood in small volume without cryo-protection in a group of people with different health status. Mutat Res Genet Toxicol Environ Mutagen. 2019 Jul;843:3-10. doi: 10.1016/j.mrgentox.2019.03.009. Epub 2019 Mar 28.
- Background: PubMed 24076402Milic M, Kisan M, Rogulj D, Radman M, Lovrencic MV, Konjevoda P, Domijan AM. Level of primary DNA damage in the early stage of metabolic syndrome. Mutat Res Genet Toxicol Environ Mutagen. 2013 Dec 12;758(1-2):1-5. doi: 10.1016/j.mrgentox.2013.07.013. Epub 2013 Sep 27.
- Background: PubMed 22056738Rogulj D, Konjevoda P, Milic M, Mladinic M, Domijan AM. Fatty liver index as an indicator of metabolic syndrome. Clin Biochem. 2012 Jan;45(1-2):68-71. doi: 10.1016/j.clinbiochem.2011.10.014. Epub 2011 Oct 26.
- Individual participant dataSharing planned: No
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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.
Mirta Milic, PhD principal investigator
Institute for Medical Research and Occupational Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Very low calorie diet in people with Obesity and Weight Loss, run by Special Hospital for Extended Treatment of Duga Resa at 1 site in Croatia.
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 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2021. 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 Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes in the body mass index (time frame: Baseline, after 3 weeks of VLCD). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05007171, which also lists 18 linked publications.
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 16 Aug 2021.