AtherosclerosisPhase 4RebuildNCT02621489
Effects on Re-endothelialisation With Bydureon Treatment in Type 2 Diabetes Subjects
A Phase 4 study testing Bydureon, Humulin kwickpen and Metformin in people with Atherosclerosis and Diabetes, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The aim of the study is to use Exenatide long-acting release (LAR) [Bydureon] to minimize vascular remodeling and neointima formation after Percutaneous Coronary Intervention (PCI) and to accelerate stent endothelialisation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atherosclerosis, Diabetes, Restenosis
- What is being tested?
- Bydureon, Humulin kwickpen and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2015to Oct 2022
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients eligible for PCI with application of DES, due to ACS.
- Patients with known or newly diagnosed T2D (type 2 diabetes is diagnosed according to current WHO criteria or by the use of anti-diabetic drugs)
- Male and female subjects 18-80 years.
- HbA1c (accordingly to IFCC) 47 mmol/mol - 110 mmol/mol.
- Signed informed consent form.
Who cannot join
- Type 1 diabetes (autoantibody positive).
- Any history of receiving GLP-1 analogues or dipeptidyl peptidase inhibitors within 6 months
- Known severe heart failure, classified as NYHA 4.
- Active myocarditis; malfunctioning artificial heart valve.
- History of ventricular tachycardia within 3 months before study entry; second- or third-degree atrioventricular block.
- Supine systolic blood pressure <85 mm Hg or >200 mm Hg at screening.
Show all 16Show fewer
- Primary renal impairment, creatinine clearance < 45 ml/min if treated with metformin.
- Uncorrected hypokalemia or hyperkalemia (potassium <3.5 mmol/l or >5.5 mmol/l).
- Significant anemia (Hb < 90 g/l)
- Severe gastrointestinal disease, including gastroparesis. As judged by the Investigator.
- Body mass index (BMI) > 45 kg/m2.
- Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy in the previous 5 years. Patients with intraepithelial squamous cell carcinoma of the skin treated with topical 5FU and subjects with basal cell skin cancer are allowed to enter the trial.
- Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant.
- Current drug and alcohol abuse.
- History of acute or chronic pancreatitis
- Subjects considered by the Investigator to be unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept of clinical science and education Karolinska Institutet Södersjukhuset
Stockholm, Other, 11883
About this study
Official title: Effects on Re-endothelialisation With Bydureon Treatment Add on to Insulin Versus Insulin Alone, Both in Combination With Metformin in Type 2 Diabetic Subjects
The aim of the study is to use Exenatide long-acting release (LAR) [Bydureon] to minimize vascular remodeling and neointima formation after Percutaneous Coronary Intervention (PCI) and to accelerate stent endothelialisation.
Read the detailed description
Exenatide LAR will be given as a once-weekly (s.c.) dose of Bydureon (2 mg) add on to Insulin in combination with Metformin. If patients are Insulin naïve (both groups) an initial dose of 10U (s.c.) at bedtime will be started, and further up-titrated to achieve a fP-glucose levels at 6 mmol/l. Standard care for post myocardial infarction will be given after PCI.
Primary objectives:
To test whether Bydureon, add on to Insulin Neutral Protamine Hagedorn (NPH) + Metformin, is superior vs. Insulin NPH + Metformin alone, in covered stent struts
Secondary objectives:
To test whether Bydureon, add on to Insulin NPH + Metformin, is superior vs. Insulin NPH + Metformin alone: in cardiac and endothelial functions
- Conditions
- Atherosclerosis, Diabetes, Restenosis
- Being tested
- Bydureon, Humulin kwickpen, Metformin
- Keywords
- Glucagon-like peptide-1, Endothelialization, Cardiac Function, Exenatide, Optical Coherence Tomography
- Medical subject headings
- Atherosclerosis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BydureonDrug
Also called Exenatide
2 mg Once Weekly
Humulin kwickpenDrug
Also called Insulin Aspart
Humulin kwickpen 10U QD at bedtime
MetforminDrug
Also called Biguanide
Metformin 1g BID
| Study group | Role | What they receive |
|---|---|---|
| Bydureon 2 mg Once Weekly | Experimental | Patients randomised to Bydureon will be treated with Metformin 1g BID, and only receive 10U of Humulin kwickpen QD at bedtime, with no more up-titration of insulin during the study. Receives: Drug: Bydureon; Drug: Humulin kwickpen; Drug: Metformin |
| Humulin kwickpen | Active comparator | Patients randomised to the comparator group will be treated with Meformin 1g BID and Humulin kwickpen to reach a fP-glucose level of 6 mmol/l. For that reason patients will be instructed to increase the bedtime Insulin dose of 2-4U every third day until this goal is reached. Receives: Drug: Humulin kwickpen; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of non-covered stent struts by Bydureon add on to Insulin over that of Insulin as analyzed by optical coherence tomography (OCT).
Measured: 12 weeks
Secondary outcomes (15)
Fractional Flow Reserve (FFR)
FFR is a unitless index calculated as the ratio between distal coronary and aortic pressure during maximum hyperemia.
Measured: 12 weeks
Coronary Flow velocity Reserve (CRF)
CFR is a unitless index calculated as the ratio between the the mean transit time recorded at maximum hyperemia and at baseline using the thermodilution.
Measured: 12 weeks
Index of Microcirculatory Resistance (IMR)
IMR is a unitless index calculated by dividing the mean distal coronary pressure by the inverse of the mean transit time recorded using the thermodilution technique during maximum hyperemia
Measured: 12 weeks
Fractional flow reserve positive re-stenosis
Measured: 12 weeks
Target lesion failure
Need of unplanned PCI in the treated stenosis or significant re-stenosis in the follow-up
Measured: 12 weeks
Acute coronary syndrome (ACS) and/or repeat revascularization
Measured: 12 weeks
Late lumen loss/neointima thickness measured with OCT
Measured: 12 weeks
Change in minimal lumen area by OCT
Measured: 12 weeks
Left ventricular systolic and diastolic function assessed by echocardiography
Measured: 12 weeks
Recovery from endothelial damage, measured by high resolution ultrasound, after PCI
Non-invasive ultrasound over the radialis artery after the PCI procedure using Standard 6-7F guiding catheters.
Measured: 12 weeks
Plasma markers of endothelial activation i.e., E-Selectin, VCAM-1, ICAM-1, nitrotyrosine levels
Measured: 12 weeks
Plasma markers of inflammation i.e., CRP, IL-1β, IL-6 and IL-8.
Measured: 12 weeks
Plasma markers of matrix remodeling enzymes i.e., MMP-2 and MMP9
Measured: 12 weeks
Circulating endothelial progenitor cells
Measured: 12 weeks
Gene expression (Affymetrix) e.g., transcription factors of sirtuins (SIRT) and nitric oxide synthase (NOS)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionAug 2022
- Study completionOct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Nystrom, Karolinska Institutet
- Investigators
- Thomas Nyström, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621489
- Sponsor's protocol ID
- BY2015
- Acronym
- Rebuild
- Status last verified
- Apr 2023
- First submitted
- 22 Nov 2015
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Eriksson L, Saxelin R, Rohl S, Roy J, Caidahl K, Nystrom T, Hedin U, Razuvaev A. Glucagon-Like Peptide-1 Receptor Activation Does not Affect Re-Endothelialization but Reduces Intimal Hyperplasia via Direct Effects on Smooth Muscle Cells in a Nondiabetic Model of Arterial Injury. J Vasc Res. 2015;52(1):41-52. doi: 10.1159/000381097. Epub 2015 May 7.
PubMed 25966620Erdogdu O, Eriksson L, Xu H, Sjoholm A, Zhang Q, Nystrom T. Exendin-4 protects endothelial cells from lipoapoptosis by PKA, PI3K, eNOS, p38 MAPK, and JNK pathways. J Mol Endocrinol. 2013 Mar 18;50(2):229-41. doi: 10.1530/JME-12-0166. Print 2013 Apr.
PubMed 23343509Erdogdu O, Nathanson D, Sjoholm A, Nystrom T, Zhang Q. Exendin-4 stimulates proliferation of human coronary artery endothelial cells through eNOS-, PKA- and PI3K/Akt-dependent pathways and requires GLP-1 receptor. Mol Cell Endocrinol. 2010 Aug 30;325(1-2):26-35. doi: 10.1016/j.mce.2010.04.022. Epub 2010 May 7.
PubMed 20452396Erdogdu O, Eriksson L, Nystrom T, Sjoholm A, Zhang Q. Exendin-4 restores glucolipotoxicity-induced gene expression in human coronary artery endothelial cells. Biochem Biophys Res Commun. 2012 Mar 23;419(4):790-5. doi: 10.1016/j.bbrc.2012.02.106. Epub 2012 Feb 27.
PubMed 22390929Nystrom T, Gutniak MK, Zhang Q, Zhang F, Holst JJ, Ahren B, Sjoholm A. Effects of glucagon-like peptide-1 on endothelial function in type 2 diabetes patients with stable coronary artery disease. Am J Physiol Endocrinol Metab. 2004 Dec;287(6):E1209-15. doi: 10.1152/ajpendo.00237.2004. Epub 2004 Sep 7.
PubMed 15353407Dokken BB, Piermarini CV, Teachey MK, Gura MT, Dameff CJ, Heller BD, Krate J, Ashgar AM, Querin L, Mitchell JL, Hilwig RW, Kern KB. Glucagon-like peptide-1 preserves coronary microvascular endothelial function after cardiac arrest and resuscitation: potential antioxidant effects. Am J Physiol Heart Circ Physiol. 2013 Feb 15;304(4):H538-46. doi: 10.1152/ajpheart.00282.2012. Epub 2012 Dec 15.
PubMed 23241323Guagliumi G, Sirbu V, Bezerra H, Biondi-Zoccai G, Fiocca L, Musumeci G, Matiashvili A, Lortkipanidze N, Tahara S, Valsecchi O, Costa M. Strut coverage and vessel wall response to zotarolimus-eluting and bare-metal stents implanted in patients with ST-segment elevation myocardial infarction: the OCTAMI (Optical Coherence Tomography in Acute Myocardial Infarction) Study. JACC Cardiovasc Interv. 2010 Jun;3(6):680-7. doi: 10.1016/j.jcin.2010.04.005.
PubMed 20630463Santos-Pardo I, Witt N, Angeras O, Nystrom T. Effects of exenatide on coronary stent's endothelialization in subjects with type 2 diabetes: a randomized controlled trial. The Rebuild study. Cardiovasc Diabetol. 2023 Dec 8;22(1):337. doi: 10.1186/s12933-023-02071-4.
PubMed 38066597
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Re-endothelialisation With Bydureon Treatment Add on to Insulin Versus Insulin Alone, Both in Combination With Metformin in Type 2 Diabetic Subjects
- ClinicalTrials.gov ID
- NCT02621489
- Acronym / sponsor ID
- Rebuild / BY2015
- Conditions
- Atherosclerosis, Diabetes, Restenosis
- Keywords
- Glucagon-like peptide-1, Endothelialization, Cardiac Function, Exenatide, Optical Coherence Tomography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Aug 2022 (actual)
- Study completion
- Oct 2022 (actual)
- First posted
- 3 Dec 2015 (estimated)
- 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.
The aim of the study is to use Exenatide long-acting release (LAR) [Bydureon] to minimize vascular remodeling and neointima formation after Percutaneous Coronary Intervention (PCI) and to accelerate stent endothelialisation.
Detailed description
Exenatide LAR will be given as a once-weekly (s.c.) dose of Bydureon (2 mg) add on to Insulin in combination with Metformin. If patients are Insulin naïve (both groups) an initial dose of 10U (s.c.) at bedtime will be started, and further up-titrated to achieve a fP-glucose levels at 6 mmol/l. Standard care for post myocardial infarction will be given after PCI.
Primary objectives:
To test whether Bydureon, add on to Insulin Neutral Protamine Hagedorn (NPH) + Metformin, is superior vs. Insulin NPH + Metformin alone, in covered stent struts
Secondary objectives:
To test whether Bydureon, add on to Insulin NPH + Metformin, is superior vs. Insulin NPH + Metformin alone: in cardiac and endothelial functions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bydureon 2 mg Once Weekly | Experimental | Drug: Bydureon, Drug: Humulin kwickpen, Drug: MetforminPatients randomised to Bydureon will be treated with Metformin 1g BID, and only receive 10U of Humulin kwickpen QD at bedtime, with no more up-titration of insulin during the study. |
| Humulin kwickpen | Active comparator | Drug: Humulin kwickpen, Drug: MetforminPatients randomised to the comparator group will be treated with Meformin 1g BID and Humulin kwickpen to reach a fP-glucose level of 6 mmol/l. For that reason patients will be instructed to increase the bedtime Insulin dose of 2-4U every third day until this goal is reached. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients eligible for PCI with application of DES, due to ACS.
- Patients with known or newly diagnosed T2D (type 2 diabetes is diagnosed according to current WHO criteria or by the use of anti-diabetic drugs)
- Male and female subjects 18-80 years.
- HbA1c (accordingly to IFCC) 47 mmol/mol - 110 mmol/mol.
- Signed informed consent form.
Key exclusion criteria (16 listed)
- Type 1 diabetes (autoantibody positive).
- Any history of receiving GLP-1 analogues or dipeptidyl peptidase inhibitors within 6 months
- Known severe heart failure, classified as NYHA 4.
- Active myocarditis; malfunctioning artificial heart valve.
- History of ventricular tachycardia within 3 months before study entry; second- or third-degree atrioventricular block.
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 |
|---|---|---|
| BydureonAlso: Exenatide2 mg Once Weekly | Drug | Bydureon 2 mg Once Weekly |
| Humulin kwickpenAlso: Insulin AspartHumulin kwickpen 10U QD at bedtime | Drug | Bydureon 2 mg Once Weekly, Humulin kwickpen |
| MetforminAlso: BiguanideMetformin 1g BID | Drug | Bydureon 2 mg Once Weekly, Humulin kwickpen |
Primary outcome
The degree of non-covered stent struts by Bydureon add on to Insulin over that of Insulin as analyzed by optical coherence tomography (OCT).
Time frame: 12 weeks
15 secondary outcomes
Fractional Flow Reserve (FFR)
Time frame: 12 weeks
Coronary Flow velocity Reserve (CRF)
Time frame: 12 weeks
Index of Microcirculatory Resistance (IMR)
Time frame: 12 weeks
Fractional flow reserve positive re-stenosis
Time frame: 12 weeks
Target lesion failure
Time frame: 12 weeks
Acute coronary syndrome (ACS) and/or repeat revascularization
Time frame: 12 weeks
Late lumen loss/neointima thickness measured with OCT
Time frame: 12 weeks
Change in minimal lumen area by OCT
Time frame: 12 weeks
Left ventricular systolic and diastolic function assessed by echocardiography
Time frame: 12 weeks
Recovery from endothelial damage, measured by high resolution ultrasound, after PCI
Time frame: 12 weeks
Plasma markers of endothelial activation i.e., E-Selectin, VCAM-1, ICAM-1, nitrotyrosine levels
Time frame: 12 weeks
Plasma markers of inflammation i.e., CRP, IL-1β, IL-6 and IL-8.
Time frame: 12 weeks
Plasma markers of matrix remodeling enzymes i.e., MMP-2 and MMP9
Time frame: 12 weeks
Circulating endothelial progenitor cells
Time frame: 12 weeks
Gene expression (Affymetrix) e.g., transcription factors of sirtuins (SIRT) and nitric oxide synthase (NOS)
Time frame: 12 weeks
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 20 Apr 2023.
- Results publication: PubMed 25966620Eriksson L, Saxelin R, Rohl S, Roy J, Caidahl K, Nystrom T, Hedin U, Razuvaev A. Glucagon-Like Peptide-1 Receptor Activation Does not Affect Re-Endothelialization but Reduces Intimal Hyperplasia via Direct Effects on Smooth Muscle Cells in a Nondiabetic Model of Arterial Injury. J Vasc Res. 2015;52(1):41-52. doi: 10.1159/000381097. Epub 2015 May 7.
- Results publication: PubMed 23343509Erdogdu O, Eriksson L, Xu H, Sjoholm A, Zhang Q, Nystrom T. Exendin-4 protects endothelial cells from lipoapoptosis by PKA, PI3K, eNOS, p38 MAPK, and JNK pathways. J Mol Endocrinol. 2013 Mar 18;50(2):229-41. doi: 10.1530/JME-12-0166. Print 2013 Apr.
- Results publication: PubMed 20452396Erdogdu O, Nathanson D, Sjoholm A, Nystrom T, Zhang Q. Exendin-4 stimulates proliferation of human coronary artery endothelial cells through eNOS-, PKA- and PI3K/Akt-dependent pathways and requires GLP-1 receptor. Mol Cell Endocrinol. 2010 Aug 30;325(1-2):26-35. doi: 10.1016/j.mce.2010.04.022. Epub 2010 May 7.
- Results publication: PubMed 22390929Erdogdu O, Eriksson L, Nystrom T, Sjoholm A, Zhang Q. Exendin-4 restores glucolipotoxicity-induced gene expression in human coronary artery endothelial cells. Biochem Biophys Res Commun. 2012 Mar 23;419(4):790-5. doi: 10.1016/j.bbrc.2012.02.106. Epub 2012 Feb 27.
- Results publication: PubMed 15353407Nystrom T, Gutniak MK, Zhang Q, Zhang F, Holst JJ, Ahren B, Sjoholm A. Effects of glucagon-like peptide-1 on endothelial function in type 2 diabetes patients with stable coronary artery disease. Am J Physiol Endocrinol Metab. 2004 Dec;287(6):E1209-15. doi: 10.1152/ajpendo.00237.2004. Epub 2004 Sep 7.
- Results publication: PubMed 23241323Dokken BB, Piermarini CV, Teachey MK, Gura MT, Dameff CJ, Heller BD, Krate J, Ashgar AM, Querin L, Mitchell JL, Hilwig RW, Kern KB. Glucagon-like peptide-1 preserves coronary microvascular endothelial function after cardiac arrest and resuscitation: potential antioxidant effects. Am J Physiol Heart Circ Physiol. 2013 Feb 15;304(4):H538-46. doi: 10.1152/ajpheart.00282.2012. Epub 2012 Dec 15.
- Results publication: PubMed 20630463Guagliumi G, Sirbu V, Bezerra H, Biondi-Zoccai G, Fiocca L, Musumeci G, Matiashvili A, Lortkipanidze N, Tahara S, Valsecchi O, Costa M. Strut coverage and vessel wall response to zotarolimus-eluting and bare-metal stents implanted in patients with ST-segment elevation myocardial infarction: the OCTAMI (Optical Coherence Tomography in Acute Myocardial Infarction) Study. JACC Cardiovasc Interv. 2010 Jun;3(6):680-7. doi: 10.1016/j.jcin.2010.04.005.
- Derived from this study: PubMed 38066597Santos-Pardo I, Witt N, Angeras O, Nystrom T. Effects of exenatide on coronary stent's endothelialization in subjects with type 2 diabetes: a randomized controlled trial. The Rebuild study. Cardiovasc Diabetol. 2023 Dec 8;22(1):337. doi: 10.1186/s12933-023-02071-4.
- 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.
Thomas Nyström principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bydureon, Humulin kwickpen and Metformin in people with Atherosclerosis and Diabetes, run by Karolinska Institutet at 1 site in Sweden.
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 5 inclusion and 16 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 20 Apr 2023. 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 Sweden. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 degree of non-covered stent struts by Bydureon add on to Insulin over that of Insulin as analyzed by optical coherence tomography (OCT). (time frame: 12 weeks). 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 NCT02621489, which also lists 8 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 20 Apr 2023.