Diabetic Peripheral NeuropathyNCT04638556
Effect of Circulating lncRNAs on Type 2 Diabetic Peripheral Neuropathy
An observational study of Diabetic Peripheral Neuropathy, run by Jinshan Hospital Fudan University at 1 site in China.
Trial summary
This project intends to use high-throughput sequencing, molecular biology and bioinformatics technology to clarify the role of target lncrnas in the inflammatory response of DPN, to explore the correlation between target lncrnas and DPN pathogenesis, and to clarify the feasibility of target lncrnas as a marker of DPN… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- lncRNA detection
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2019to 31 Dec 2022
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The normal group is healthy adults without any diseases. The T2DM group included patients with simple type 2 diabetes without complications of type 2 diabetes and other underlying diseases. The DPN group included patients with simple T2DM combined with DPN.
Who may be able to join
- Healthy Volunteers
- Patients who were diagnosed with type 2 diabetes in accordance with the Chinese guidelines for the prevention and treatment of type 2 diabetes (2017 Edition) Patients who decided to voluntarily participate in clinical trials and agreed in writing
- Patients who were diagnosed with type 2 diabetes in accordance with the Chinese guidelines for the prevention and treatment of type 2 diabetes (2017 Edition) Neuropathy at or after the diagnosis of diabetes Clinical symptoms include: numbness or sensation, tingling or tingling, pain, abnormal sensitivity or tenderness after touching
- Examination item include:
- abnormal temperature sense
- 10 g nylon thread examination, foot sensation decreased or disappeared
Show all 9Show fewer
- abnormal vibration sense
- ankle reflex disappeared
- two or more items of nerve conduction velocity were slowed down (electromyography or sensory threshold measurement) Patients with two of the above five items were abnormal, or patients with clinical symptoms plus 1 item
Who cannot join
- Peripheral neuropathy
- The T2DM group
- Patients with diabetic complication Patients with a systolic blood pressure(SBP)≥ 160 mmHg or ≤ 100 mmHg or a diastolic blood pressure(DBP) ≥ 95 mmHg or ≤ 60 mmHg Patients with other disease
- The DPN group
- Nerve injury caused by other diseases or drugs Patients with T1DM or other endocrine system diseases, acute complications of diabetes, such as diabetic ketoacidosis and hypertonic non ketotic coma, cardiovascular and cerebrovascular diseases, nonalcoholic fatty liver disease, liver and kidney failure, inflammatory diseases, active infection, cancer, pregnancy or lactation Patients with a systolic blood pressure(SBP)≥ 160 mmHg or ≤ 100 mmHg or a diastolic blood pressure(DBP) ≥ 95 mmHg or ≤ 60 mmHg In addition to the above items, patients who are deemed inappropriate by clinical trial researchers
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jinshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 201508
Xiaohong Shi, +86-021-57039893, xiaohongshi@fudan.edu.cn
About this study
Official title: The Effect of Circulating lncRNAs on Type 2 Diabetic Peripheral Neuropathy by Regulating miR-146a
This project intends to use high-throughput sequencing, molecular biology and bioinformatics technology to clarify the role of target lncrnas in the inflammatory response of DPN, to explore the correlation between target lncrnas and DPN pathogenesis, and to clarify the feasibility of target lncrnas as a marker of DPN cycle.
Read the detailed description
- Screening lncrnas that regulate DPN inflammatory response and bind to miR-146a ① Experimental grouping The experiment was divided into T2DM group and DPN group. T2DM group was simple type 2 diabetes, without complications and other basic diseases; DPN group was simple T2DM patients with DPN. The diagnostic criteria for T2DM patients were in accordance with the Chinese guidelines for the prevention and treatment of type 2 diabetes (2017 Edition). The screening criteria for T2DM patients with DPN are as follows: 1. Clear history of type 2 diabetes mellitus. 2. Neuropathy at or after the diagnosis of diabetes. 3. The clinical symptoms and signs were consistent with those of DPN. Clinical symptoms include: numbness or sensation; tingling or tingling; pain; abnormal sensitivity or tenderness after touching. 4. Examination: A. abnormal temperature sense; B. 10 g nylon thread examination, foot sensation decreased or disappeared; C. abnormal vibration sense; D. ankle reflex disappeared; e. two or more items of nerve conduction velocity were slowed down (electromyography or sensory threshold measurement). 5. Nerve injury caused by other diseases or drugs was excluded. Two of the above five items were abnormal, or clinical symptoms + 1 item were abnormal. ② Under the condition of full informed consent, 3ml plasma samples were collected from T2DM group and DPN group, 4 copies in each group, and stored in refrigerator at - 80 ℃. ③ Screening of lncrnas and mRNAs differentially expressed in two groups of samples by gene sequencing. Total RNA was extracted from tissue samples. The concentration and purity of RNA were detected by Nanodrop2000. The integrity of RNA was detected by agarose gel electrophoresis, and RIN value was determined by Agilent2100. The total RNA of a single library was 2 UG, the concentration was more than 100 ng / μ L, od260 / 280 was between 1.8 ~ 2.2, and rRNA was removed. Using metal ions, the mRNA was randomly broken into small fragments of about 200 bp. Under the action of reverse transcriptase, a single strand of cDNA was synthesized by using random primers and using mRNA as template. The second strand of cDNA was synthesized by substituting dUTP for dTTP. The structure of the double stranded cDNA is a sticky end. The end repair mix is added to make up the flat end, and then an a base is added at the 3 'end to connect the Y-shaped junction. The second strand of cDNA was digested by ung enzyme so that only the first strand of cDNA was contained in the library. Then the Illumina sequencer platform was used for sequencing to obtain the original sequencing data. The differentially expressed lncrnas and mRNAs were obtained by quality control and sequence alignment. ④ The lncrnas with difference multiple ≥ 2 were obtained, and the lncrnas co expressed with inflammatory factors were determined by co expression analysis. ⑤ Different lncnras were retrieved from mircode and Starbase databases to obtain lncnras combined with miR-146a.
- In vitro validation of candidate lncnras: ① high concentration glucose (200mmol / L) induced injury of Schwann cells; ② detection of the expression of candidate lncnras and miR-146a in high glucose induced Schwann cells to obtain lncnras with high expression; ③ double luciferase reporter gene experiment to verify the combination of candidate lncnras and miR-146a, and obtain candidate lncnras binding to miR-146a; ④ construction Methods: lncnras silencing vector was used to transfer candidate lncnras into high glucose induced Schwann cells; ⑤ Western blot and liquid chip were used to detect the levels of inflammatory factors (TNF - α, IL-1 β, IL-6 and IL-10) in Schwann cells; and ⑥ correlation analysis was used to determine the lncrnas positively correlated with inflammatory factors.
- Large plasma samples were used to verify the correlation between candidate lncrnas and miR-146a and inflammatory factors.
- the experimental grouping was the same as before; ② with full informed consent, 50 plasma samples were collected from T2DM patients and T2DM patients with DPN, each 3ml each. ③ candidate lncrnas and miR-146a primers were designed and QRT PCR was used to detect the candidate lncrnas and miR-146a The levels of inflammatory factors (TNF - α, IL-1 β, IL-6 and IL-10) in the plasma of the two groups were detected by liquid chip technology; ⑤ lncrnas negatively correlated with miR-146a and positively correlated with the expression of inflammatory factors were determined by correlation analysis.
- Statistical treatment: SPSS 23.0 software was used for statistical analysis. The measurement data are expressed as mean ± SD One way ANOVA or nonparametric test was used to analyze the distribution and grouping characteristics. Pearson correlation analysis was used to analyze the correlation of measurement data. With P < 0.05, the difference was statistically significant.
- Technical route this study is mainly divided into three parts. Firstly, lncrnas that regulate DPN inflammatory response and bind with miR-146a are screened; on this basis, candidate lncnras are obtained by in vitro validation; finally, lncnras with molecular marker function are verified on large sample plasma samples.
- Technical difficulties In this study, we used gene sequencing technology to detect the differential expression of lncrnas and mRNAs in plasma of T2DM patients and DPN patients, combined with bioinformatics technology to screen lncrnas related to inflammation and bind to miR-146a. Objective to screen for miR-146a binding proteins associated with inflammation Lncrnas are the technical difficulties in this study.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- lncRNA detection
- Keywords
- diabetic peripheral neuropathy, long non-coding RNA, microRNA-146a, inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lncRNA detectionDiagnostic test
The lncRNAs in the plasma of three groups of patients will be tested.
| Study group | Role | What they receive |
|---|---|---|
| Normal | A healthy, disease-free population. Receives: Diagnostic Test: lncRNA detection | |
| T2DM | T2DM group was simple type 2 diabetes mellitus. Receives: Diagnostic Test: lncRNA detection | |
| DPN | The screening criteria for T2DM patients with DPN are as follows: 1. Clear history of type 2 diabetes mellitus. 2. Neuropathy at or after the diagnosis of diabetes. 3. The clinical symptoms and signs were consistent with those of DPN. Clinical symptoms include: numbness or sensation; tingling or tingling; pain; abnormal sensitivity or tenderness after touching. 4. Examination: A. abnormal temperature sense; B. 10 g nylon thread examination, foot sensation decreased or disappeared; C. abnormal vibration sense; D. ankle reflex disappeared; e. two or more items of nerve conduction velocity were slowed down (electromyography or sensory threshold measurement). 5. Nerve injury caused by other diseases or drugs was excluded. Two of the above five items were abnormal, or clinical symptoms + 1 item were abnormal. Receives: Diagnostic Test: lncRNA detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nerve conduction velocity
NCV was measured in the sural nerve. For the determination of motor nerve conduction velocity(MNCV), the sciatic nerve was stimulated with single supramaximal square wave pulses(5to10 Ma and 40μs duration) via fine needle electrodes inserted percutaneously.The distance between the two sites of stimulation was 2mm. MNCV was calculated by subtracting the distal latency from the proximal latency,and the result was divided into the distance between the stimulating and recording electrode.Sensory nerve conduction velocity(SNCV) was meaured and recorded.The site of stimulation was located in the ankle and the recording site was in the sciatic notch.The maximal SNCV was calculated by measuring the latency to the onset/peak of the initial negative deflection and the distance between stimulating and recording electrodes,and the result was divided by latency period.
Measured: 2020.09-2022.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start3 Sep 2019
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinshan Hospital Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Municipal Commission of Health and Family Planning
- Responsible party
- Principal investigator, Xiaohong Shi, Jinshan Hospital Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638556
- Sponsor's protocol ID
- 201940362
- Status last verified
- Nov 2020
- First submitted
- 16 Nov 2020
- Last updated
- 30 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data use permission requires to be approved by the funder.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Circulating lncRNAs on Type 2 Diabetic Peripheral Neuropathy by Regulating miR-146a
- ClinicalTrials.gov ID
- NCT04638556
- Acronym / sponsor ID
- 201940362
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- diabetic peripheral neuropathy, long non-coding RNA, microRNA-146a, inflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Jinshan Hospital Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Municipal Commission of Health and Family Planning
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 20 Nov 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.
This project intends to use high-throughput sequencing, molecular biology and bioinformatics technology to clarify the role of target lncrnas in the inflammatory response of DPN, to explore the correlation between target lncrnas and DPN pathogenesis, and to clarify the feasibility of target lncrnas as a marker of DPN cycle.
Detailed description
- Screening lncrnas that regulate DPN inflammatory response and bind to miR-146a ① Experimental grouping The experiment was divided into T2DM group and DPN group. T2DM group was simple type 2 diabetes, without complications and other basic diseases; DPN group was simple T2DM patients with DPN. The diagnostic criteria for T2DM patients were in accordance with the Chinese guidelines for the prevention and treatment of type 2 diabetes (2017 Edition). The screening criteria for T2DM patients with DPN are as follows: 1. Clear history of type 2 diabetes mellitus. 2. Neuropathy at or after the diagnosis of diabetes. 3. The clinical symptoms and signs were consistent with those of DPN. Clinical symptoms include: numbness or sensation; tingling or tingling; pain; abnormal sensitivity or tenderness after touching. 4. Examination: A. abnormal temperature sense; B. 10 g nylon thread examination, foot sensation decreased or disappeared; C. abnormal vibration sense; D. ankle reflex disappeared; e. two or more items of nerve conduction velocity were slowed down (electromyography or sensory threshold measurement). 5. Nerve injury caused by other diseases or drugs was excluded. Two of the above five items were abnormal, or clinical symptoms + 1 item were abnormal. ② Under the condition of full informed consent, 3ml plasma samples were collected from T2DM group and DPN group, 4 copies in each group, and stored in refrigerator at - 80 ℃. ③ Screening of lncrnas and mRNAs differentially expressed in two groups of samples by gene sequencing. Total RNA was extracted from tissue samples. The concentration and purity of RNA were detected by Nanodrop2000. The integrity of RNA was detected by agarose gel electrophoresis, and RIN value was determined by Agilent2100. The total RNA of a single library was 2 UG, the concentration was more than 100 ng / μ L, od260 / 280 was between 1.8 ~ 2.2, and rRNA was removed. Using metal ions, the mRNA was randomly broken into small fragments of about 200 bp. Under the action of reverse transcriptase, a single strand of cDNA was synthesized by using random primers and using mRNA as template. The second strand of cDNA was synthesized by substituting dUTP for dTTP. The structure of the double stranded cDNA is a sticky end. The end repair mix is added to make up the flat end, and then an a base is added at the 3 'end to connect the Y-shaped junction. The second strand of cDNA was digested by ung enzyme so that only the first strand of cDNA was contained in the library. Then the Illumina sequencer platform was used for sequencing to obtain the original sequencing data. The differentially expressed lncrnas and mRNAs were obtained by quality control and sequence alignment. ④ The lncrnas with difference multiple ≥ 2 were obtained, and the lncrnas co expressed with inflammatory factors were determined by co expression analysis. ⑤ Different lncnras were retrieved from mircode and Starbase databases to obtain lncnras combined with miR-146a.
- In vitro validation of candidate lncnras: ① high concentration glucose (200mmol / L) induced injury of Schwann cells; ② detection of the expression of candidate lncnras and miR-146a in high glucose induced Schwann cells to obtain lncnras with high expression; ③ double luciferase reporter gene experiment to verify the combination of candidate lncnras and miR-146a, and obtain candidate lncnras binding to miR-146a; ④ construction Methods: lncnras silencing vector was used to transfer candidate lncnras into high glucose induced Schwann cells; ⑤ Western blot and liquid chip were used to detect the levels of inflammatory factors (TNF - α, IL-1 β, IL-6 and IL-10) in Schwann cells; and ⑥ correlation analysis was used to determine the lncrnas positively correlated with inflammatory factors.
- Large plasma samples were used to verify the correlation between candidate lncrnas and miR-146a and inflammatory factors.
- the experimental grouping was the same as before; ② with full informed consent, 50 plasma samples were collected from T2DM patients and T2DM patients with DPN, each 3ml each. ③ candidate lncrnas and miR-146a primers were designed and QRT PCR was used to detect the candidate lncrnas and miR-146a The levels of inflammatory factors (TNF - α, IL-1 β, IL-6 and IL-10) in the plasma of the two groups were detected by liquid chip technology; ⑤ lncrnas negatively correlated with miR-146a and positively correlated with the expression of inflammatory factors were determined by correlation analysis.
- Statistical treatment: SPSS 23.0 software was used for statistical analysis. The measurement data are expressed as mean ± SD One way ANOVA or nonparametric test was used to analyze the distribution and grouping characteristics. Pearson correlation analysis was used to analyze the correlation of measurement data. With P < 0.05, the difference was statistically significant.
- Technical route this study is mainly divided into three parts. Firstly, lncrnas that regulate DPN inflammatory response and bind with miR-146a are screened; on this basis, candidate lncnras are obtained by in vitro validation; finally, lncnras with molecular marker function are verified on large sample plasma samples.
- Technical difficulties In this study, we used gene sequencing technology to detect the differential expression of lncrnas and mRNAs in plasma of T2DM patients and DPN patients, combined with bioinformatics technology to screen lncrnas related to inflammation and bind to miR-146a. Objective to screen for miR-146a binding proteins associated with inflammation Lncrnas are the technical difficulties in this study.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal | – | Diagnostic Test: lncRNA detectionA healthy, disease-free population. |
| T2DM | – | Diagnostic Test: lncRNA detectionT2DM group was simple type 2 diabetes mellitus. |
| DPN | – | Diagnostic Test: lncRNA detectionThe screening criteria for T2DM patients with DPN are as follows: 1. Clear history of type 2 diabetes mellitus. 2. Neuropathy at or after the diagnosis of diabetes. 3. The clinical symptoms and signs were consistent with those of DPN. Clinical symptoms include: numbness or sensation; tingling or tingling; pain; abnormal sensitivity or tenderness after touching. 4. Examination: A. abnormal temperature sense; B. 10 g nylon thread examination, foot sensation decreased or disappeared; C. abnormal vibration sense; D. ankle reflex disappeared; e. two or more items of nerve conduction velocity were slowed down (electromyography or sensory threshold measurement). 5. Nerve injury caused by other diseases or drugs was excluded. Two of the above five items were abnormal, or clinical symptoms + 1 item were abnormal. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The normal group is healthy adults without any diseases. The T2DM group included patients with simple type 2 diabetes without complications of type 2 diabetes and other underlying diseases. The DPN group included patients with simple T2DM combined with DPN.
Key inclusion criteria (9 listed)
- Healthy Volunteers
- Patients who were diagnosed with type 2 diabetes in accordance with the Chinese guidelines for the prevention and treatment of type 2 diabetes (2017 Edition) Patients who decided to voluntarily participate in clinical trials and agreed in writing
- Patients who were diagnosed with type 2 diabetes in accordance with the Chinese guidelines for the prevention and treatment of type 2 diabetes (2017 Edition) Neuropathy at or after the diagnosis of diabetes Clinical symptoms include: numbness or sensation, tingling or tingling, pain, abnormal sensitivity or tenderness after touching
- abnormal temperature sense
- 10 g nylon thread examination, foot sensation decreased or disappeared
Key exclusion criteria (5 listed)
- Peripheral neuropathy
- The T2DM group
- Patients with diabetic complication Patients with a systolic blood pressure(SBP)≥ 160 mmHg or ≤ 100 mmHg or a diastolic blood pressure(DBP) ≥ 95 mmHg or ≤ 60 mmHg Patients with other disease
- The DPN group
- Nerve injury caused by other diseases or drugs Patients with T1DM or other endocrine system diseases, acute complications of diabetes, such as diabetic ketoacidosis and hypertonic non ketotic coma, cardiovascular and cerebrovascular diseases, nonalcoholic fatty liver disease, liver and kidney failure, inflammatory diseases, active infection, cancer, pregnancy or lactation Patients with a systolic blood pressure(SBP)≥ 160 mmHg or ≤ 100 mmHg or a diastolic blood pressure(DBP) ≥ 95 mmHg or ≤ 60 mmHg In addition to the above items, patients who are deemed inappropriate by clinical trial researchers
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 |
|---|---|---|
| lncRNA detectionThe lncRNAs in the plasma of three groups of patients will be tested. | Diagnostic test | DPN, Normal, T2DM |
Primary outcome
Nerve conduction velocity
Time frame: 2020.09-2022.12
NCV was measured in the sural nerve. For the determination of motor nerve conduction velocity(MNCV), the sciatic nerve was stimulated with single supramaximal square wave pulses(5to10 Ma and 40μs duration) via fine needle electrodes inserted percutaneously.The distance between the two sites of stimulation was 2mm. MNCV was calculated by subtracting the distal latency from the proximal latency,and the result was divided into the distance between the stimulating and recording electrode.Sensory nerve conduction velocity(SNCV) was meaured and recorded.The site of stimulation was located in the ankle and the recording site was in the sciatic notch.The maximal SNCV was calculated by measuring the latency to the onset/peak of the initial negative deflection and the distance between stimulating and recording electrodes,and the result was divided by latency period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- Individual participant dataSharing planned: Undecided. Data use permission requires to be approved by the funder.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Peripheral Neuropathy, run by Jinshan Hospital Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 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 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact An Qi, undergraduate (86+021-57039818, jsyyllwyh2018@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nerve conduction velocity (time frame: 2020.09-2022.12). 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 30 Nov 2020.