Obesity & OverweightPANFAT-BSNCT07464223
MRI Assessment of Pancreatic Fat Changes and Islet Function Recovery After Bariatric Surgery in Obese Patients
An observational study of Obesity & Overweight and Type 2 Diabetes Mellitus (T2DM), run by yu li，MD at 1 site in China.
Trial summary
This study evaluates changes in pancreatic fat and recovery of pancreatic function in obese patients undergoing laparoscopic sleeve gastrectomy (LSG), a weight-loss surgery. Obesity can cause fat to accumulate in the pancreas, which may impair insulin production and lead to type 2 diabetes. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Obesity & Overweight, Type 2 Diabetes Mellitus (T2DM), Pancreatic Steatosis
- What is being tested?
- Laparoscopic Sleeve Gastrectomy (LSG)
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 30 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Obese patients aged 16-60 years with BMI >32 kg/m² undergoing laparoscopic sleeve gastrectomy at Qingdao University Affiliated Hospital. Participants must have preoperative evidence of pancreatic fat infiltration and complete medical records. Both male and female patients are eligible.
Who may be able to join
- Age between 16 and 60 years
- BMI > 32 kg/m²
- Preoperative auxiliary examination supports diagnosis of pancreatic fat infiltration
- Willing to undergo pancreatic MRI examination
- Previous attempts at other weight loss methods have been ineffective
- Complete medical records available
- Voluntary signed informed consent
- Scheduled to undergo laparoscopic sleeve gastrectomy (LSG) at Qingdao University Affiliated Hospital
Who cannot join
- Secondary obesity
- Previous major gastrointestinal surgery
- Diagnosed gastric or duodenal ulcer
- Gastrointestinal diseases associated with malabsorption
- Other diseases causing abnormal pancreatic function
- BMI < 32 kg/m²
Show all 10Show fewer
- Poor compliance or self-control, unable to follow dietary guidance after surgery
- Unable to complete follow-up visits
- Contraindications for MRI examination
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Longitudinal Study Based on MRI to Evaluate the Changes of Pancreatic Fat and the Recovery of Pancreatic Function in Obese Patients After Bariatric Surgery
This study evaluates changes in pancreatic fat and recovery of pancreatic function in obese patients undergoing laparoscopic sleeve gastrectomy (LSG), a weight-loss surgery.
Obesity can cause fat to accumulate in the pancreas, which may impair insulin production and lead to type 2 diabetes. This study uses magnetic resonance imaging (MRI) to measure pancreatic fat before and after surgery to understand how weight loss affects pancreatic function.
Read more
About 50 obese patients (BMI > 32 kg/m²) aged 16-60 years who are scheduled for LSG will be enrolled. Participants will undergo MRI scans of the pancreas and blood tests before surgery and at 1, 3, and 6 months after surgery. The MRI uses a safe, non-invasive technique called Dixon imaging to measure fat content in different parts of the pancreas (head, body, and tail). Blood tests will measure fasting glucose, insulin, C-peptide, and HbA1c to assess pancreatic function.
The study aims to determine whether reduction in pancreatic fat after weight-loss surgery is associated with improved insulin secretion and reduced insulin resistance. This information may help doctors better understand how bariatric surgery improves metabolic health and guide postoperative patient management.
Participation involves no additional risk beyond routine clinical care. All MRI scans and blood tests are part of standard postoperative monitoring for bariatric surgery patients.
Read the detailed description
See attached protocol for detailed study design, eligibility criteria, and outcome measures.
- Conditions
- Obesity & Overweight, Type 2 Diabetes Mellitus (T2DM), Pancreatic Steatosis, Insulin Resistance
- Being tested
- Laparoscopic Sleeve Gastrectomy (LSG)
- Keywords
- Bariatric Surgery, Sleeve Gastrectomy, Pancreatic Fat, MRI, Dixon Imaging, Islet Function, Insulin Secretion, Metabolic Surgery, Diabetes Remission
- Medical subject headings
- Obesity, Overweight, Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Sleeve Gastrectomy (LSG)Procedure or surgery
Standard laparoscopic sleeve gastrectomy performed by experienced surgeons. This is the routine clinical procedure for weight loss, not an experimental intervention. The study observes pancreatic fat changes and metabolic outcomes following this standard surgery.
| Study group | Role | What they receive |
|---|---|---|
| Obese patients undergoing LSG | Obese patients (BMI > 32 kg/m²) aged 16-60 years undergoing laparoscopic sleeve gastrectomy (LSG), with pancreatic fat infiltration confirmed by preoperative MRI. Participants will be assessed at baseline (preoperative) and at 1, 3, and 6 months postoperatively. Receives: Procedure: Laparoscopic Sleeve Gastrectomy (LSG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pancreatic Fat Content
Pancreatic fat fraction will be measured using MRI Dixon imaging at pancreatic head, body, and tail. Fat fraction (%) = [(SI in-phase - SI opposed-phase) / (2 × SI in-phase)] × 100.
Measured: Baseline (preoperative), 1 month, 3 months, and 6 months postoperatively
Change in Insulin Resistance Index (HOMA-IR)
Insulin resistance will be assessed using the Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) calculated as: [fasting plasma glucose (mmol/L) × fasting insulin (μU/mL)] / 22.5. Fasting plasma glucose will be measured by glucose oxidase method and fasting insulin will be measured by chemiluminescence immunoassay. Higher HOMA-IR values indicate greater insulin resistance.
Measured: Baseline (preoperative), 1 month, 3 months, and 6 months postoperatively
Change in Pancreatic Beta-cell Function
Pancreatic beta-cell function will be assessed using HOMA-%β (Homeostasis Model Assessment for beta-cell function) calculated as: HOMA-%β = [20 × fasting insulin (μU/mL)] / [fasting glucose (mmol/L) - 3.5] (%). Fasting blood glucose, fasting insulin, C-peptide, and HbA1c will be measured at each time point.
Measured: Baseline (preoperative), 1 month, 3 months, and 6 months postoperatively
Secondary outcomes (3)
Change in Body Weight and BMI
Body weight will be measured using calibrated electronic scales with subjects wearing light clothing and no shoes. Height will be measured using a stadiometer. BMI will be calculated as weight (kg) divided by height squared (m²). Percentage of total weight loss (%TWL) and percentage of excess weight loss (%EWL) will also be calculated to assess surgical efficacy.
Measured: Baseline (preoperative), 1 month, 3 months, and 6 months postoperatively
Change in Pancreatic Fat Distribution (Head, Body, Tail)
Regional pancreatic fat content will be measured separately at pancreatic head, body, and tail using MRI Dixon imaging. Three regions of interest (ROI) will be drawn at the maximal cross-sectional area of each pancreatic segment. Fat fraction (%) = [(SI in-phase - SI opposed-phase) / (2 × SI in-phase)] × 100. This allows assessment of differential fat reduction patterns across pancreatic regions and correlation with regional islet function recovery.
Measured: Baseline (preoperative), 1 month, 3 months, and 6 months postoperatively
Correlation Between Pancreatic Fat Reduction and Islet Function Recovery
Correlation analysis between the magnitude of pancreatic fat reduction (measured by MRI Dixon) and improvement in islet function parameters (HOMA-%β, HOMA-IR, fasting insulin, C-peptide). This will identify whether pancreatic fat reduction is an independent predictor of beta-cell function recovery after laparoscopic sleeve gastrectomy.
Measured: Baseline to 6 months postoperatively (change scores will be calculated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start1 Sep 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Obesity & OverweightStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- yu li，MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, yu li，MD, The Affiliated Hospital of Qingdao University
- Investigators
- Yu Lu, MD, PhD, Study chair, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464223
- Sponsor's protocol ID
- QYFYEC2024-233
- Acronym
- PANFAT-BS
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying published results will be shared upon reasonable request to the corresponding author (Dr. Yu Li, Liyu11920@hotmail.com) after publication of primary results. Data sharing will begin: 12 months after publication of primary results Data will be shared with: Researchers who provide a methodologically sound proposal Data sharing mechanism: Secure file transfer or email Types of data to be shared: De-identified participant-level data, data dictionary, and statistical analysis plan Supporting documents: Study protocol and informed consent form will be available upon request
Publications
Silva Junior MF, Batista MJ, de Sousa MDLR. Correction: Risk factors for tooth loss in adults: A population-based prospective cohort study. PLoS One. 2019 Dec 16;14(12):e0226794. doi: 10.1371/journal.pone.0226794. eCollection 2019.
PubMed 31841552Yoshino M, Kayser BD, Yoshino J, Stein RI, Reeds D, Eagon JC, Eckhouse SR, Watrous JD, Jain M, Knight R, Schechtman K, Patterson BW, Klein S. Effects of Diet versus Gastric Bypass on Metabolic Function in Diabetes. N Engl J Med. 2020 Aug 20;383(8):721-732. doi: 10.1056/NEJMoa2003697.
PubMed 32813948Vieira-Leite-Segundo A, Lima Falcao MF, Correia-Lins Filho R, Marques Soares MS, Lopez Lopez J, Chimenos Kustner E. Multiple myeloma with primary manifestation in the mandible: a case report. Med Oral Patol Oral Cir Bucal. 2008 Apr 1;13(4):E232-4.
PubMed 18379446Nannipieri M, Baldi S, Mari A, Colligiani D, Guarino D, Camastra S, Barsotti E, Berta R, Moriconi D, Bellini R, Anselmino M, Ferrannini E. Roux-en-Y gastric bypass and sleeve gastrectomy: mechanisms of diabetes remission and role of gut hormones. J Clin Endocrinol Metab. 2013 Nov;98(11):4391-9. doi: 10.1210/jc.2013-2538. Epub 2013 Sep 20.
PubMed 24057293De Luca M, Zese M, Bandini G, Chiappetta S, Iossa A, Merola G, Piatto G, Tolone S, Vitiello A, Silverii GA, Ragghianti B, Mannucci E, Monami M; Expert Panel and Evidence Review Team for the Italian Guidelines on Bariatric and Metabolic Surgery. Metabolic bariatric surgery as a therapeutic option for patients with type 2 diabetes: A meta-analysis and network meta-analysis of randomized controlled trials. Diabetes Obes Metab. 2023 Aug;25(8):2362-2373. doi: 10.1111/dom.15117. Epub 2023 Jun 5.
PubMed 37272316Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R, Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1. Epub 2017 Dec 5.
PubMed 29221645
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study Based on MRI to Evaluate the Changes of Pancreatic Fat and the Recovery of Pancreatic Function in Obese Patients After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT07464223
- Acronym / sponsor ID
- PANFAT-BS / QYFYEC2024-233
- Conditions
- Obesity & Overweight, Type 2 Diabetes Mellitus (T2DM), Pancreatic Steatosis, Insulin Resistance
- Keywords
- Bariatric Surgery, Sleeve Gastrectomy, Pancreatic Fat, MRI, Dixon Imaging, Islet Function, Insulin Secretion, Metabolic Surgery
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- yu li，MDUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 11 Mar 2026 (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 study evaluates changes in pancreatic fat and recovery of pancreatic function in obese patients undergoing laparoscopic sleeve gastrectomy (LSG), a weight-loss surgery.
Obesity can cause fat to accumulate in the pancreas, which may impair insulin production and lead to type 2 diabetes. This study uses magnetic resonance imaging (MRI) to measure pancreatic fat before and after surgery to understand how weight loss affects pancreatic function.
About 50 obese patients (BMI > 32 kg/m²) aged 16-60 years who are scheduled for LSG will be enrolled. Participants will undergo MRI scans of the pancreas and blood tests before surgery and at 1, 3, and 6 months after surgery. The MRI uses a safe, non-invasive technique called Dixon imaging to measure fat content in different parts of the pancreas (head, body, and tail). Blood tests will measure fasting glucose, insulin, C-peptide, and HbA1c to assess pancreatic function.
The study aims to determine whether reduction in pancreatic fat after weight-loss surgery is associated with improved insulin secretion and reduced insulin resistance. This information may help doctors better understand how bariatric surgery improves metabolic health and guide postoperative patient management.
Participation involves no additional risk beyond routine clinical care. All MRI scans and blood tests are part of standard postoperative monitoring for bariatric surgery patients.
Detailed description
See attached protocol for detailed study design, eligibility criteria, and outcome measures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese patients undergoing LSG | – | Procedure: Laparoscopic Sleeve Gastrectomy (LSG)Obese patients (BMI > 32 kg/m²) aged 16-60 years undergoing laparoscopic sleeve gastrectomy (LSG), with pancreatic fat infiltration confirmed by preoperative MRI. Participants will be assessed at baseline (preoperative) and at 1, 3, and 6 months postoperatively. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Obese patients aged 16-60 years with BMI >32 kg/m² undergoing laparoscopic sleeve gastrectomy at Qingdao University Affiliated Hospital. Participants must have preoperative evidence of pancreatic fat infiltration and complete medical records. Both male and female patients are eligible.
Key inclusion criteria (8 listed)
- Age between 16 and 60 years
- BMI > 32 kg/m²
- Preoperative auxiliary examination supports diagnosis of pancreatic fat infiltration
- Willing to undergo pancreatic MRI examination
- Previous attempts at other weight loss methods have been ineffective
Key exclusion criteria (10 listed)
- Secondary obesity
- Previous major gastrointestinal surgery
- Diagnosed gastric or duodenal ulcer
- Gastrointestinal diseases associated with malabsorption
- Other diseases causing abnormal pancreatic function
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 |
|---|---|---|
| Laparoscopic Sleeve Gastrectomy (LSG)Standard laparoscopic sleeve gastrectomy performed by experienced surgeons. This is the routine clinical procedure for weight loss, not an experimental intervention. The study observes pancreatic fat changes and metabolic outcomes following this standard surgery. | Procedure or surgery | Obese patients undergoing LSG |
Primary outcome
Change in Pancreatic Fat Content
Time frame: Baseline (preoperative), 1 month, 3 months, and 6 months postoperatively
Pancreatic fat fraction will be measured using MRI Dixon imaging at pancreatic head, body, and tail. Fat fraction (%) = [(SI in-phase - SI opposed-phase) / (2 × SI in-phase)] × 100.
Change in Insulin Resistance Index (HOMA-IR)
Time frame: Baseline (preoperative), 1 month, 3 months, and 6 months postoperatively
Insulin resistance will be assessed using the Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) calculated as: [fasting plasma glucose (mmol/L) × fasting insulin (μU/mL)] / 22.5. Fasting plasma glucose will be measured by glucose oxidase method and fasting insulin will be measured by chemiluminescence immunoassay. Higher HOMA-IR values indicate greater insulin resistance.
Change in Pancreatic Beta-cell Function
Time frame: Baseline (preoperative), 1 month, 3 months, and 6 months postoperatively
Pancreatic beta-cell function will be assessed using HOMA-%β (Homeostasis Model Assessment for beta-cell function) calculated as: HOMA-%β = [20 × fasting insulin (μU/mL)] / [fasting glucose (mmol/L) - 3.5] (%). Fasting blood glucose, fasting insulin, C-peptide, and HbA1c will be measured at each time point.
3 secondary outcomes
Change in Body Weight and BMI
Time frame: Baseline (preoperative), 1 month, 3 months, and 6 months postoperatively
Change in Pancreatic Fat Distribution (Head, Body, Tail)
Time frame: Baseline (preoperative), 1 month, 3 months, and 6 months postoperatively
Correlation Between Pancreatic Fat Reduction and Islet Function Recovery
Time frame: Baseline to 6 months postoperatively (change scores will be calculated)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Background: PubMed 31841552Silva Junior MF, Batista MJ, de Sousa MDLR. Correction: Risk factors for tooth loss in adults: A population-based prospective cohort study. PLoS One. 2019 Dec 16;14(12):e0226794. doi: 10.1371/journal.pone.0226794. eCollection 2019.
- Background: PubMed 32813948Yoshino M, Kayser BD, Yoshino J, Stein RI, Reeds D, Eagon JC, Eckhouse SR, Watrous JD, Jain M, Knight R, Schechtman K, Patterson BW, Klein S. Effects of Diet versus Gastric Bypass on Metabolic Function in Diabetes. N Engl J Med. 2020 Aug 20;383(8):721-732. doi: 10.1056/NEJMoa2003697.
- Background: PubMed 18379446Vieira-Leite-Segundo A, Lima Falcao MF, Correia-Lins Filho R, Marques Soares MS, Lopez Lopez J, Chimenos Kustner E. Multiple myeloma with primary manifestation in the mandible: a case report. Med Oral Patol Oral Cir Bucal. 2008 Apr 1;13(4):E232-4.
- Background: PubMed 24057293Nannipieri M, Baldi S, Mari A, Colligiani D, Guarino D, Camastra S, Barsotti E, Berta R, Moriconi D, Bellini R, Anselmino M, Ferrannini E. Roux-en-Y gastric bypass and sleeve gastrectomy: mechanisms of diabetes remission and role of gut hormones. J Clin Endocrinol Metab. 2013 Nov;98(11):4391-9. doi: 10.1210/jc.2013-2538. Epub 2013 Sep 20.
- Background: PubMed 37272316De Luca M, Zese M, Bandini G, Chiappetta S, Iossa A, Merola G, Piatto G, Tolone S, Vitiello A, Silverii GA, Ragghianti B, Mannucci E, Monami M; Expert Panel and Evidence Review Team for the Italian Guidelines on Bariatric and Metabolic Surgery. Metabolic bariatric surgery as a therapeutic option for patients with type 2 diabetes: A meta-analysis and network meta-analysis of randomized controlled trials. Diabetes Obes Metab. 2023 Aug;25(8):2362-2373. doi: 10.1111/dom.15117. Epub 2023 Jun 5.
- Background: PubMed 29221645Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R, Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1. Epub 2017 Dec 5.
- American Society for Metabolic and Bariatric SurgeryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying published results will be shared upon reasonable request to the corresponding author (Dr. Yu Li, Liyu11920@hotmail.com) after publication of primary results. Data sharing will begin: 12 months after publication of primary results Data will be shared with: Researchers who provide a methodologically sound proposal Data sharing mechanism: Secure file transfer or email Types of data to be shared: De-identified participant-level data, data dictionary, and statistical analysis plan Supporting documents: Study protocol and informed consent form will be available upon request
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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.
Yu Lu, MD, PhD study chair
The Affiliated Hospital of Qingdao University
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 Obesity & Overweight and Type 2 Diabetes Mellitus (T2DM), run by yu li，MD 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 8 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Pancreatic Fat Content (time frame: Baseline (preoperative), 1 month, 3 months, and 6 months postoperatively). The study lists 3 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 NCT07464223, which also lists 6 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 12 Mar 2026.