Type 1 DiabetesWBH001NCT04730882
Effect of Postprandial Hyperglycemia on Vasculature in Type 1 Diabetes and Healthy Adults
An observational study of Type 1 Diabetes and Hyperglycemia, Postprandial, run by University of Virginia at 1 site in United States.
Trial summary
To the investigator's knowledge, there are no data available in the current literature regarding the acute effects of postprandial hyperglycemia and insulin timing on myocardial perfusion in people with type 1 diabetes (T1D). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes, Hyperglycemia, Postprandial
- What is being tested?
- Mixed Meal
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2021to 18 Oct 2024
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 17 Healthy controls and 17 participants with T1D
Who may be able to join
- Healthy with no chronic illness
- Age 18-35 years
- BMI ≤ 30 (wt kg/ht m2)
- Normal screening labs or no clinically significant values
- T1D participants must have T1D based on WHO diagnostic criteria for > 1 year
- A fasting plasma glucose level >126 mg/dl (7.0 mmol/l)
Show all 9Show fewer
- A casual plasma glucose >200 mg/dl (11.1 mmol/l)
- In the absence of unequivocal hyperglycemia, the diagnosis must be confirmed on a subsequent day.
- Subjects using sensor-augmented insulin pump therapy and/or artificial pancreas (closed loop system) will be included
Who cannot join
- • Smoking presently or have quit < 2 years.
- BP >140/90 mmHg
- BMI >30 (wt kg/ht m2)
- Pulse oximetry <90%
- Elevated LDL cholesterol > 160 mg/dl
- HbA1c ≥ 9 %
Show all 13Show fewer
- Use of statins, calcium channel blocker, ACE, ARB, nitrates, alpha-beta blockers or diuretics
- History of cardiac, cerebrovascular, gastrointestinal, liver, renal decease or cancer
- Presence of an intracardiac or intrapulmonary shunt (we will screen for this by auscultation during the physical exam by PI).
- Retinopathy (beyond mild non proliferative retinopathy)
- Urine albumin/creatinine ratio > 300 mg per g
- Pregnant or breastfeeding.
- Known hypersensitivity to perflutren (contained in Definity
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22906
About this study
To the investigator's knowledge, there are no data available in the current literature regarding the acute effects of postprandial hyperglycemia and insulin timing on myocardial perfusion in people with type 1 diabetes (T1D). Observational studies using CEU in type 2 diabetes demonstrate that postprandial hyperglycemia determines myocardial perfusion defects. The investigator hypothesizes that the combination of postprandial hyperglycemia and insulin increases pulse wave velocity (i.e., aortic stiffness) and myocardial vasoconstriction, thereby reducing myocardial perfusion in T1D when compared to healthy controls. Furthermore, the investigator hypothesizes in T1D that dosing insulin before meal intake will ameliorate these cardiovascular defects.
Read the detailed description
The investigator will compare 17 T1D and 17 age-, sex-, and BMI-matched healthy controls (18-35 yrs) measuring pulse wave velocity (PWV), flow-mediated dilation (FMD) and myocardial perfusion (contrast enhanced ultrasound [CEU]) before and 2 hours after ingesting a mixed meal (40% of each subject's daily estimated caloric need, with 50%, 30%, 20% from carbohydrates, fat and protein, respectively).
T1D participants will have 2 study admissions:
- injection of insulin 15 minutes before ingesting a mixed meal. B) injection of insulin 15 min after ingesting a mixed meal.
- Conditions
- Type 1 Diabetes, Hyperglycemia, Postprandial
- Being tested
- Mixed Meal
- Medical subject headings
- Diabetes Mellitus, Type 1, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed MealDietary supplement
the meal will be 40% of each subject's daily estimated caloric need, with 50%, 30%, 20% from carbohydrates, fat and protein, respectively
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control | Healthy subjects 18-35 years of age Receives: Dietary Supplement: Mixed Meal | |
| Type 1 Diabetes | People with type 1 diabetes (18-35 yrs) who have type 1 diabetes based on WHO diagnostic criteria for > 1 year Receives: Dietary Supplement: Mixed Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial Microvascular Perfusion (measured by contrast-enhanced ultrasound)
Measurement of change in myocardial microvascular perfusion
Measured: baseline and 2 hours after a meal
Secondary outcomes (8)
Skeletal Muscle Microvascular Perfusion (measured by contrast-enhanced ultrasound)
Measurement of change in microvascular perfusion of skeletal muscle
Measured: baseline and 2 hours after a meal
Flow Mediated Dilation
Vascular measure of change in conduit artery stiffness
Measured: baseline and 2 hours after a meal
Pulse Wave Velocity ( PWV)
Measurement of change in central artery stiffness
Measured: baseline and 2 hours after a meal
Tumor Necrosis Factor-Alpha (TNF-alpha)
Inflammatory biomarker (plasma sample) specific specific to patients with type 1 diabetes
Measured: baseline and 2 hours after a meal
Interleukin 6 (IL-6)
Inflammatory biomarker (plasma sample) specific specific to patients with type 1 diabetes
Measured: baseline and 2 hours after a meal
high sensitivity C-reactive protein (hsCRP)
Inflammatory biomarker (plasma sample) specific specific to patients with type 1 diabetes
Measured: baseline and 2 hours after a meal
Intercellular Adhesion Molecule 1 (ICAM-1)
Biomarker (plasma sample) of endothelial dysfunction
Measured: baseline and 2 hours after a meal
E-selectin
Biomarker (plasma sample) of endothelial dysfunction
Measured: baseline and 2 hours after a meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start6 Apr 2021
- Primary completion18 Oct 2024
- Study completion18 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (73)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, William Horton, MD, University of Virginia
- Investigators
- William Horton, MD, Principal investigator, University of Virginia, Department of EndocrinologyZhenqi Liu, MD, Study chair, University of Virginia, Department of Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730882
- Sponsor's protocol ID
- 200216
- Other IDs
- KL2TR003016
- Acronym
- WBH001
- Status last verified
- Mar 2025
- First submitted
- 25 Jan 2021
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lind M, Svensson AM, Kosiborod M, Gudbjornsdottir S, Pivodic A, Wedel H, Dahlqvist S, Clements M, Rosengren A. Glycemic control and excess mortality in type 1 diabetes. N Engl J Med. 2014 Nov 20;371(21):1972-82. doi: 10.1056/NEJMoa1408214.
PubMed 25409370Lee AK, Warren B, Lee CJ, McEvoy JW, Matsushita K, Huang ES, Sharrett AR, Coresh J, Selvin E. The Association of Severe Hypoglycemia With Incident Cardiovascular Events and Mortality in Adults With Type 2 Diabetes. Diabetes Care. 2018 Jan;41(1):104-111. doi: 10.2337/dc17-1669. Epub 2017 Nov 10.
PubMed 29127240Goto A, Goto M, Terauchi Y, Yamaguchi N, Noda M. Association Between Severe Hypoglycemia and Cardiovascular Disease Risk in Japanese Patients With Type 2 Diabetes. J Am Heart Assoc. 2016 Mar 9;5(3):e002875. doi: 10.1161/JAHA.115.002875.
PubMed 26961698Aryangat AV, Gerich JE. Type 2 diabetes: postprandial hyperglycemia and increased cardiovascular risk. Vasc Health Risk Manag. 2010 Mar 24;6:145-55. doi: 10.2147/vhrm.s8216.
PubMed 20448799Ceriello A, Hanefeld M, Leiter L, Monnier L, Moses A, Owens D, Tajima N, Tuomilehto J. Postprandial glucose regulation and diabetic complications. Arch Intern Med. 2004 Oct 25;164(19):2090-5. doi: 10.1001/archinte.164.19.2090.
PubMed 15505121Cavalot F, Petrelli A, Traversa M, Bonomo K, Fiora E, Conti M, Anfossi G, Costa G, Trovati M. Postprandial blood glucose is a stronger predictor of cardiovascular events than fasting blood glucose in type 2 diabetes mellitus, particularly in women: lessons from the San Luigi Gonzaga Diabetes Study. J Clin Endocrinol Metab. 2006 Mar;91(3):813-9. doi: 10.1210/jc.2005-1005. Epub 2005 Dec 13.
PubMed 16352690Livingstone SJ, Looker HC, Hothersall EJ, Wild SH, Lindsay RS, Chalmers J, Cleland S, Leese GP, McKnight J, Morris AD, Pearson DW, Peden NR, Petrie JR, Philip S, Sattar N, Sullivan F, Colhoun HM. Risk of cardiovascular disease and total mortality in adults with type 1 diabetes: Scottish registry linkage study. PLoS Med. 2012;9(10):e1001321. doi: 10.1371/journal.pmed.1001321. Epub 2012 Oct 2.
PubMed 23055834Action to Control Cardiovascular Risk in Diabetes Study Group; Gerstein HC, Miller ME, Byington RP, Goff DC Jr, Bigger JT, Buse JB, Cushman WC, Genuth S, Ismail-Beigi F, Grimm RH Jr, Probstfield JL, Simons-Morton DG, Friedewald WT. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2545-59. doi: 10.1056/NEJMoa0802743. Epub 2008 Jun 6.
PubMed 18539917Currie CJ, Peters JR, Tynan A, Evans M, Heine RJ, Bracco OL, Zagar T, Poole CD. Survival as a function of HbA(1c) in people with type 2 diabetes: a retrospective cohort study. Lancet. 2010 Feb 6;375(9713):481-9. doi: 10.1016/S0140-6736(09)61969-3. Epub 2010 Jan 26.
PubMed 20110121Saisho Y. Glycemic variability and oxidative stress: a link between diabetes and cardiovascular disease? Int J Mol Sci. 2014 Oct 13;15(10):18381-406. doi: 10.3390/ijms151018381.
PubMed 25314300Risso A, Mercuri F, Quagliaro L, Damante G, Ceriello A. Intermittent high glucose enhances apoptosis in human umbilical vein endothelial cells in culture. Am J Physiol Endocrinol Metab. 2001 Nov;281(5):E924-30. doi: 10.1152/ajpendo.2001.281.5.E924.
PubMed 11595647Quagliaro L, Piconi L, Assaloni R, Martinelli L, Motz E, Ceriello A. Intermittent high glucose enhances apoptosis related to oxidative stress in human umbilical vein endothelial cells: the role of protein kinase C and NAD(P)H-oxidase activation. Diabetes. 2003 Nov;52(11):2795-804. doi: 10.2337/diabetes.52.11.2795.
PubMed 14578299Piconi L, Quagliaro L, Assaloni R, Da Ros R, Maier A, Zuodar G, Ceriello A. Constant and intermittent high glucose enhances endothelial cell apoptosis through mitochondrial superoxide overproduction. Diabetes Metab Res Rev. 2006 May-Jun;22(3):198-203. doi: 10.1002/dmrr.613.
PubMed 16453381Horvath EM, Benko R, Kiss L, Muranyi M, Pek T, Fekete K, Barany T, Somlai A, Csordas A, Szabo C. Rapid 'glycaemic swings' induce nitrosative stress, activate poly(ADP-ribose) polymerase and impair endothelial function in a rat model of diabetes mellitus. Diabetologia. 2009 May;52(5):952-61. doi: 10.1007/s00125-009-1304-0. Epub 2009 Mar 5.
PubMed 19263033Ceriello A, Esposito K, Piconi L, Ihnat MA, Thorpe JE, Testa R, Boemi M, Giugliano D. Oscillating glucose is more deleterious to endothelial function and oxidative stress than mean glucose in normal and type 2 diabetic patients. Diabetes. 2008 May;57(5):1349-54. doi: 10.2337/db08-0063. Epub 2008 Feb 25.
PubMed 18299315
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Postprandial Hyperglycemia on Vasculature in Type 1 Diabetes and Healthy Adults
- ClinicalTrials.gov ID
- NCT04730882
- Acronym / sponsor ID
- WBH001 / 200216
- Conditions
- Type 1 Diabetes, Hyperglycemia, Postprandial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 18 Oct 2024 (actual)
- Study completion
- 18 Oct 2024 (actual)
- First posted
- 29 Jan 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.
To the investigator's knowledge, there are no data available in the current literature regarding the acute effects of postprandial hyperglycemia and insulin timing on myocardial perfusion in people with type 1 diabetes (T1D). Observational studies using CEU in type 2 diabetes demonstrate that postprandial hyperglycemia determines myocardial perfusion defects. The investigator hypothesizes that the combination of postprandial hyperglycemia and insulin increases pulse wave velocity (i.e., aortic stiffness) and myocardial vasoconstriction, thereby reducing myocardial perfusion in T1D when compared to healthy controls. Furthermore, the investigator hypothesizes in T1D that dosing insulin before meal intake will ameliorate these cardiovascular defects.
Detailed description
The investigator will compare 17 T1D and 17 age-, sex-, and BMI-matched healthy controls (18-35 yrs) measuring pulse wave velocity (PWV), flow-mediated dilation (FMD) and myocardial perfusion (contrast enhanced ultrasound [CEU]) before and 2 hours after ingesting a mixed meal (40% of each subject's daily estimated caloric need, with 50%, 30%, 20% from carbohydrates, fat and protein, respectively).
T1D participants will have 2 study admissions:
- injection of insulin 15 minutes before ingesting a mixed meal. B) injection of insulin 15 min after ingesting a mixed meal.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | – | Dietary Supplement: Mixed MealHealthy subjects 18-35 years of age |
| Type 1 Diabetes | – | Dietary Supplement: Mixed MealPeople with type 1 diabetes (18-35 yrs) who have type 1 diabetes based on WHO diagnostic criteria for > 1 year |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 17 Healthy controls and 17 participants with T1D
Key inclusion criteria (9 listed)
- Healthy with no chronic illness
Key exclusion criteria (13 listed)
- • Smoking presently or have quit < 2 years.
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 |
|---|---|---|
| Mixed Mealthe meal will be 40% of each subject's daily estimated caloric need, with 50%, 30%, 20% from carbohydrates, fat and protein, respectively | Dietary supplement | Healthy Control, Type 1 Diabetes |
Primary outcome
Myocardial Microvascular Perfusion (measured by contrast-enhanced ultrasound)
Time frame: baseline and 2 hours after a meal
Measurement of change in myocardial microvascular perfusion
8 secondary outcomes
Skeletal Muscle Microvascular Perfusion (measured by contrast-enhanced ultrasound)
Time frame: baseline and 2 hours after a meal
Flow Mediated Dilation
Time frame: baseline and 2 hours after a meal
Pulse Wave Velocity ( PWV)
Time frame: baseline and 2 hours after a meal
Tumor Necrosis Factor-Alpha (TNF-alpha)
Time frame: baseline and 2 hours after a meal
Interleukin 6 (IL-6)
Time frame: baseline and 2 hours after a meal
high sensitivity C-reactive protein (hsCRP)
Time frame: baseline and 2 hours after a meal
Intercellular Adhesion Molecule 1 (ICAM-1)
Time frame: baseline and 2 hours after a meal
E-selectin
Time frame: baseline and 2 hours after a meal
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 30 Mar 2025.
- Background: PubMed 25409370Lind M, Svensson AM, Kosiborod M, Gudbjornsdottir S, Pivodic A, Wedel H, Dahlqvist S, Clements M, Rosengren A. Glycemic control and excess mortality in type 1 diabetes. N Engl J Med. 2014 Nov 20;371(21):1972-82. doi: 10.1056/NEJMoa1408214.
- Background: PubMed 29127240Lee AK, Warren B, Lee CJ, McEvoy JW, Matsushita K, Huang ES, Sharrett AR, Coresh J, Selvin E. The Association of Severe Hypoglycemia With Incident Cardiovascular Events and Mortality in Adults With Type 2 Diabetes. Diabetes Care. 2018 Jan;41(1):104-111. doi: 10.2337/dc17-1669. Epub 2017 Nov 10.
- Background: PubMed 26961698Goto A, Goto M, Terauchi Y, Yamaguchi N, Noda M. Association Between Severe Hypoglycemia and Cardiovascular Disease Risk in Japanese Patients With Type 2 Diabetes. J Am Heart Assoc. 2016 Mar 9;5(3):e002875. doi: 10.1161/JAHA.115.002875.
- Background: PubMed 20448799Aryangat AV, Gerich JE. Type 2 diabetes: postprandial hyperglycemia and increased cardiovascular risk. Vasc Health Risk Manag. 2010 Mar 24;6:145-55. doi: 10.2147/vhrm.s8216.
- Background: PubMed 15505121Ceriello A, Hanefeld M, Leiter L, Monnier L, Moses A, Owens D, Tajima N, Tuomilehto J. Postprandial glucose regulation and diabetic complications. Arch Intern Med. 2004 Oct 25;164(19):2090-5. doi: 10.1001/archinte.164.19.2090.
- Background: PubMed 16352690Cavalot F, Petrelli A, Traversa M, Bonomo K, Fiora E, Conti M, Anfossi G, Costa G, Trovati M. Postprandial blood glucose is a stronger predictor of cardiovascular events than fasting blood glucose in type 2 diabetes mellitus, particularly in women: lessons from the San Luigi Gonzaga Diabetes Study. J Clin Endocrinol Metab. 2006 Mar;91(3):813-9. doi: 10.1210/jc.2005-1005. Epub 2005 Dec 13.
- Background: PubMed 23055834Livingstone SJ, Looker HC, Hothersall EJ, Wild SH, Lindsay RS, Chalmers J, Cleland S, Leese GP, McKnight J, Morris AD, Pearson DW, Peden NR, Petrie JR, Philip S, Sattar N, Sullivan F, Colhoun HM. Risk of cardiovascular disease and total mortality in adults with type 1 diabetes: Scottish registry linkage study. PLoS Med. 2012;9(10):e1001321. doi: 10.1371/journal.pmed.1001321. Epub 2012 Oct 2.
- Background: PubMed 18539917Action to Control Cardiovascular Risk in Diabetes Study Group; Gerstein HC, Miller ME, Byington RP, Goff DC Jr, Bigger JT, Buse JB, Cushman WC, Genuth S, Ismail-Beigi F, Grimm RH Jr, Probstfield JL, Simons-Morton DG, Friedewald WT. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2545-59. doi: 10.1056/NEJMoa0802743. Epub 2008 Jun 6.
- Background: PubMed 20110121Currie CJ, Peters JR, Tynan A, Evans M, Heine RJ, Bracco OL, Zagar T, Poole CD. Survival as a function of HbA(1c) in people with type 2 diabetes: a retrospective cohort study. Lancet. 2010 Feb 6;375(9713):481-9. doi: 10.1016/S0140-6736(09)61969-3. Epub 2010 Jan 26.
- Background: PubMed 25314300Saisho Y. Glycemic variability and oxidative stress: a link between diabetes and cardiovascular disease? Int J Mol Sci. 2014 Oct 13;15(10):18381-406. doi: 10.3390/ijms151018381.
- Background: PubMed 11595647Risso A, Mercuri F, Quagliaro L, Damante G, Ceriello A. Intermittent high glucose enhances apoptosis in human umbilical vein endothelial cells in culture. Am J Physiol Endocrinol Metab. 2001 Nov;281(5):E924-30. doi: 10.1152/ajpendo.2001.281.5.E924.
- Background: PubMed 14578299Quagliaro L, Piconi L, Assaloni R, Martinelli L, Motz E, Ceriello A. Intermittent high glucose enhances apoptosis related to oxidative stress in human umbilical vein endothelial cells: the role of protein kinase C and NAD(P)H-oxidase activation. Diabetes. 2003 Nov;52(11):2795-804. doi: 10.2337/diabetes.52.11.2795.
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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.
William Horton, MD principal investigator
University of Virginia, Department of Endocrinology
Zhenqi Liu, MD study chair
University of Virginia, Department of Endocrinology
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 Type 1 Diabetes and Hyperglycemia, Postprandial, run by University of Virginia at 1 site in United States.
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 13 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 30 Mar 2025. 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 United States. 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?
Myocardial Microvascular Perfusion (measured by contrast-enhanced ultrasound) (time frame: baseline and 2 hours after a meal). 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 NCT04730882, which also lists 73 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 30 Mar 2025.