ObesityNCT00139477

Study of Serum Markers for Cardiovascular Risk in Obese Youth and Impact of Lifestyle and Medication Intervention

A study testing Metformin, Dietary modification with caloric restriction and Establishment of exercise protocol in people with Obesity, run by Nemours Children's Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 7 to 18 yearsHealthy volunteers can take part
Conditions the study is for: Obesity
What is being tested?: Metformin, Dietary modification with caloric restriction and Establishment of exercise protocol
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteUnited States
Study dates: Nov 2003to Sep 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 7 to 18 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Ages 7-18 years.
Greater than the 95th percentile body mass index for their age and gender.
Children are in Tanner Stage I or IV or V.
Normal Blood Pressure.
Normal fasting glucose.
Normal lipids.

Show all 10Show fewer

Menstruating girls must have completed their most recent period at least 2 weeks prior to blood draw.
No recent illness, no chronic illnesses, no routine medications, no smoking or alcohol intake.
Must pass the screening test done in Protocol #1.
Must have higher values than normal for certain blood tests related to heart disease that were measured in Protocol #1.

Who cannot join

Chronic active illnesses.
Recent illnesses.
Use of routine medications, vitamins, herbal remedies, oral contraceptive pills, or other over the counter medications within 4 weeks of blood draw.
History of recent or chronic smoking.
Currently pregnant.
Impaired fasting glucose.

Show all 11Show fewer

Dyslipidemia.
Actively in puberty.
Weight greater than 300 pounds.
Metal in the abdomen.
History of being overweight greater than 5 years.

Trial locations and contacts

1 site in 1 country.

United States1 site

Nemours Children's Clinic
Jacksonville, Florida, 32207

Other trials in United States

About this study

Official title: Understanding the Effects of Therapeutic Intervention on Cardiovascular Risk Markers, Insulin Resistance, and Intra-Hepatic Fat Contents in Obese Children at High Risk for the Metabolic Syndrome.

In Protocol #2, we will select 30 obese pubertal and 30 obese prepubertal subjects with an abnormal cytokine profile (i.e. fibrinogen and/or hsCRP concentration greater than or equal to 2 Standard Deviations (SD) above the mean established in our lab for lean controls in Protocol #1). They will be randomly assigned to either lifestyle intervention (diet/exercise) or diet/exercise plus metformin for 6 months. After the 6 month evaluation the subjects will cross over the treatment arms, i.e., those that were doing diet/exercise intervention only will add metformin, those that were doing the diet/exercise plus metformin will discontinue the metformin and continue with diet/exercise changes only. Intrahepatic fat contents will be measured as well.

The investigators hypothesize that obese children in these age groups will have increased cardiovascular risk related to their obese state before reaching the currently defined criteria of metabolic syndrome.

The investigators hypothesize that these cardiovascular risks can be reduced with lifestyle and drug interventions.

Conditions: Obesity
Being tested: Metformin, Dietary modification with caloric restriction, Establishment of exercise protocol
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MetforminDrug
Metformin, 250mg by mouth twice a day with meals will be started and if tolerated increased to 500mg twice a day in 3 days in those less than 12 years old and titrated further to 1000mg twice a day if tolerated.
Dietary modification with caloric restrictionBehavioural
The life style intervention changes will include a hypocaloric diet representing at least a 500 kcal/day reduction based on their dietary histories and Resting Energy Expenditure (REE) determined by the initial calorimetry.
Establishment of exercise protocolBehavioural
Participants will attend the Fitness Center 3 times per week and supervised by an exercise technician or exercise specialist. Exercise will be individually prescribed for each participant based on their functional abilities. Exercise will consist of 5-10 minutes for warm up and stretching, followed by 15-30 minutes of cardiovascular exercise (i.e. treadmill, bicycle ergometer, rower, nustep, etc), 10-20 minutes of strength training (supervised using weight stack equipment), and 5-10 minutes of cool down and stretching. As children typically do not need an exercise prescription based on heart rate, we will familiarize them with perceived exertion scales and monitor that they are exercising in the moderate to hard range of perception of effort. Participants will be started at 15 minutes of cardiovascular exercise and 10 minutes of strength training exercise, progressing by 2-3 minutes every week until 30 and 20 minutes is achieved for each respectively.

Study groups in NCT00139477
Study group	Role	What they receive
Diet/Exercise only, then Diet/Exercise plus Metformin	Experimental	Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Receives: Drug: Metformin; Behavioral: Dietary modification with caloric restriction; Behavioral: Establishment of exercise protocol
Diet/Exercise plus Metformin, then Diet/Exercise only	Active comparator	Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Receives: Drug: Metformin; Behavioral: Dietary modification with caloric restriction; Behavioral: Establishment of exercise protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at 6 Months
Value at 6 months minus value at baseline. HsCRP is an acute phase protein which is a sensitive marker for systemic inflammation. HsCRP concentrations were measured in our laboratory by immuno-nephelometry (Siemens Healthcare Diagnostics, Deerfield IL, USA), with an hsCRP lower sensitivity of 0.156 mg/L.
Measured: Baseline and 6 months
Change From Baseline in Fibrinogen at 6 Months
Value at 6 months minus value at baseline. Fibrinogen is a hepatic-derived factor directly involved in clotting and in the viscosity characteristics of blood flow. It binds to platelets and contributes to their aggregation, promotes fibrin formation and is also an acute phase reactant that is increased in inflammatory states. Fibrinogen concentrations were measured in our laboratory by immuno-nephelometry (Siemens Healthcare Diagnostics, Deerfield IL, USA).
Measured: Baseline and 6 months
Change From Baseline in Interleukin 6 (IL-6) at 6 Months
Value at 6 months minus value at baseline. IL-6 is a pro-inflammatory cytokine thought to produce a state of low-grade inflammation in obese individuals. IL-6 stimulates hepatic production of C-reactive protein (CRP), an acute phase protein which is a sensitive marker for systemic inflammation. IL-6 was measured by enzyme-linked immunosorbent assay (ELISA; R\&D Systems, Minneapolis, MN, USA).
Measured: Baseline and 6 months
Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at 6 Months
Value at 6 months minus value at baseline. PAI-1 is the primary physiological inhibitor of fibrinolysis and proteolysis. High PAI-1 levels have been linked to thrombosis and fibrosis, insulin resistance and obesity. PAI-1 was measured by ELISA (American Diagnostica, Stamford, CT, USA).
Measured: Baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2003Sep 2011

First posted31 Aug 2005 (estimated)
Study startNov 2003
Primary completionMay 2009
Study completionSep 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00139477
Sponsor's protocol ID: 04-032
Status last verified: Oct 2012
First submitted: 29 Aug 2005
Last updated: 18 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Mauras N, Delgiorno C, Kollman C, Bird K, Morgan M, Sweeten S, Balagopal P, Damaso L. Obesity without established comorbidities of the metabolic syndrome is associated with a proinflammatory and prothrombotic state, even before the onset of puberty in children. J Clin Endocrinol Metab. 2010 Mar;95(3):1060-8. doi: 10.1210/jc.2009-1887. Epub 2010 Jan 8.
PubMed 20061420
Rynders C, Weltman A, Delgiorno C, Balagopal P, Damaso L, Killen K, Mauras N. Lifestyle intervention improves fitness independent of metformin in obese adolescents. Med Sci Sports Exerc. 2012 May;44(5):786-92. doi: 10.1249/MSS.0b013e31823cef5e.
PubMed 22015710
Mauras N, DelGiorno C, Hossain J, Bird K, Killen K, Merinbaum D, Weltman A, Damaso L, Balagopal P. Metformin use in children with obesity and normal glucose tolerance--effects on cardiovascular markers and intrahepatic fat. J Pediatr Endocrinol Metab. 2012;25(1-2):33-40. doi: 10.1515/jpem-2011-0450.
PubMed 22570948
Benson M, Hossain J, Caulfield MP, Damaso L, Gidding S, Mauras N. Lipoprotein subfractions by ion mobility in lean and obese children. J Pediatr. 2012 Dec;161(6):997-1003. doi: 10.1016/j.jpeds.2012.05.060. Epub 2012 Jul 20.
PubMed 22819275

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Understanding the Effects of Therapeutic Intervention on Cardiovascular Risk Markers, Insulin Resistance, and Intra-Hepatic Fat Contents in Obese Children at High Risk for the Metabolic Syndrome.
ClinicalTrials.gov ID: NCT00139477
Acronym / sponsor ID: 04-032
Conditions: Obesity
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Nemours Children's ClinicUniversity, hospital or other
Collaborators: Thrasher Research Fund
Study start: Nov 2003
Primary completion: May 2009 (actual)
Study completion: Sep 2011 (actual)
First posted: 31 Aug 2005 (estimated)
Results: Posted 11 Oct 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The investigators hypothesize that these cardiovascular risks can be reduced with lifestyle and drug interventions.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Diet/Exercise only, then Diet/Exercise plus Metformin	Experimental	Drug: Metformin, Behavioral: Dietary modification with caloric restriction, Behavioral: Establishment of exercise protocolDiet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period).
Diet/Exercise plus Metformin, then Diet/Exercise only	Active comparator	Drug: Metformin, Behavioral: Dietary modification with caloric restriction, Behavioral: Establishment of exercise protocolDiet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period).

Who may qualify

Ages: 7 to 18 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (10 listed)

Ages 7-18 years.
Greater than the 95th percentile body mass index for their age and gender.
Children are in Tanner Stage I or IV or V.
Normal Blood Pressure.
Normal fasting glucose.

Key exclusion criteria (11 listed)

Chronic active illnesses.
Recent illnesses.
Use of routine medications, vitamins, herbal remedies, oral contraceptive pills, or other over the counter medications within 4 weeks of blood draw.
History of recent or chronic smoking.
Currently pregnant.

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
MetforminMetformin, 250mg by mouth twice a day with meals will be started and if tolerated increased to 500mg twice a day in 3 days in those less than 12 years old and titrated further to 1000mg twice a day if tolerated.	Drug	Diet/Exercise only, then Diet/Exercise plus Metformin, Diet/Exercise plus Metformin, then Diet/Exercise only
Dietary modification with caloric restrictionThe life style intervention changes will include a hypocaloric diet representing at least a 500 kcal/day reduction based on their dietary histories and Resting Energy Expenditure (REE) determined by the initial calorimetry.	Behavioural	Diet/Exercise only, then Diet/Exercise plus Metformin, Diet/Exercise plus Metformin, then Diet/Exercise only
Establishment of exercise protocolParticipants will attend the Fitness Center 3 times per week and supervised by an exercise technician or exercise specialist. Exercise will be individually prescribed for each participant based on their functional abilities. Exercise will consist of 5-10 minutes for warm up and stretching, followed by 15-30 minutes of cardiovascular exercise (i.e. treadmill, bicycle ergometer, rower, nustep, etc), 10-20 minutes of strength training (supervised using weight stack equipment), and 5-10 minutes of cool down and stretching. As children typically do not need an exercise prescription based on heart rate, we will familiarize them with perceived exertion scales and monitor that they are exercising in the moderate to hard range of perception of effort. Participants will be started at 15 minutes of cardiovascular exercise and 10 minutes of strength training exercise, progressing by 2-3 minutes every week until 30 and 20 minutes is achieved for each respectively.	Behavioural	Diet/Exercise only, then Diet/Exercise plus Metformin, Diet/Exercise plus Metformin, then Diet/Exercise only

Primary outcome

Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at 6 Months
Time frame: Baseline and 6 months
Value at 6 months minus value at baseline. HsCRP is an acute phase protein which is a sensitive marker for systemic inflammation. HsCRP concentrations were measured in our laboratory by immuno-nephelometry (Siemens Healthcare Diagnostics, Deerfield IL, USA), with an hsCRP lower sensitivity of 0.156 mg/L.
Change From Baseline in Fibrinogen at 6 Months
Time frame: Baseline and 6 months
Value at 6 months minus value at baseline. Fibrinogen is a hepatic-derived factor directly involved in clotting and in the viscosity characteristics of blood flow. It binds to platelets and contributes to their aggregation, promotes fibrin formation and is also an acute phase reactant that is increased in inflammatory states. Fibrinogen concentrations were measured in our laboratory by immuno-nephelometry (Siemens Healthcare Diagnostics, Deerfield IL, USA).
Change From Baseline in Interleukin 6 (IL-6) at 6 Months
Time frame: Baseline and 6 months
Value at 6 months minus value at baseline. IL-6 is a pro-inflammatory cytokine thought to produce a state of low-grade inflammation in obese individuals. IL-6 stimulates hepatic production of C-reactive protein (CRP), an acute phase protein which is a sensitive marker for systemic inflammation. IL-6 was measured by enzyme-linked immunosorbent assay (ELISA; R\&D Systems, Minneapolis, MN, USA).
Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at 6 Months
Time frame: Baseline and 6 months
Value at 6 months minus value at baseline. PAI-1 is the primary physiological inhibitor of fibrinolysis and proteolysis. High PAI-1 levels have been linked to thrombosis and fibrosis, insulin resistance and obesity. PAI-1 was measured by ELISA (American Diagnostica, Stamford, CT, USA).

Results and safety

Results posted to the registry on 11 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diet/Exercise Only, Then Diet/Exercise Plus Metformin	31	19
Diet/Exercise Plus Metformin, Then Diet/Exercise Only	35	23

Primary outcome: Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at 6 Months

Time frame: Baseline and 6 months. Median (Inter-Quartile Range). Unit: mg/dL

Measure	Diet/Exercise, Then Diet/Exercise Plus Metformin (Prepubertal) n = 8	Diet/Exercise, Then Diet/Exercise Plus Metformin (Pubertal) n = 11	Diet/Exercise Plus Metformin, Then Diet/Exercise (Prepubertal) n = 13	Diet/Exercise Plus Metformin, Then Diet/Exercise (Pubertal) n = 9
Value	-0.37 (-1.54 to 0.81)	-1.78 (-5.49 to -0.15)	-0.29 (-1.42 to 1.79)	0.00 (-0.65 to 2.17)

Population analysed: 1 Subject in the "Diet/Exercise plus Metformin, then Diet/Exercise (Pubertal)" Group did not have an hsCRP level available for analysis.

Primary outcome: Change From Baseline in Fibrinogen at 6 Months

Time frame: Baseline and 6 months. Median (Inter-Quartile Range). Unit: mg/dL

Measure	Diet/Exercise, Then Diet/Exercise Plus Metformin (Prepubertal) n = 8	Diet/Exercise, Then Diet/Exercise Plus Metformin (Pubertal) n = 11	Diet/Exercise Plus Metformin, Then Diet/Exercise (Prepubertal) n = 13	Diet/Exercise Plus Metformin, Then Diet/Exercise (Pubertal) n = 9
Value	58.5 (-64 to 123.75)	-105 (-141 to -31)	0.00 (-51.5 to 83)	-33 (-93.5 to 40.5)

Population analysed: 1 Subject in the "Diet/Exercise plus Metformin, then Diet/Exercise (Pubertal)" Group did not have a Fibrinogen level available for analysis.

Primary outcome: Change From Baseline in Interleukin 6 (IL-6) at 6 Months

Time frame: Baseline and 6 months. Median (Inter-Quartile Range). Unit: pg/mL

Measure	Diet/Exercise, Then Diet/Exercise Plus Metformin (Prepubertal) n = 8	Diet/Exercise, Then Diet/Exercise Plus Metformin (Pubertal) n = 11	Diet/Exercise Plus Metformin, Then Diet/Exercise (Prepubertal) n = 13	Diet/Exercise Plus Metformin, Then Diet/Exercise (Pubertal) n = 10
Value	-0.66 (-2.39 to -0.01)	-0.99 (-2.11 to 0.22)	0.2 (-0.80 to 2.19)	-0.35 (-0.94 to 0.07)

Primary outcome: Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at 6 Months

Time frame: Baseline and 6 months. Median (Inter-Quartile Range). Unit: ng/ML

Measure	Diet/Exercise, Then Diet/Exercise Plus Metformin (Prepubertal) n = 8	Diet/Exercise, Then Diet/Exercise Plus Metformin (Pubertal) n = 10	Diet/Exercise Plus Metformin, Then Diet/Exercise (Prepubertal) n = 13	Diet/Exercise Plus Metformin, Then Diet/Exercise (Pubertal) n = 9
Value	6.98 (-48.54 to 14.4)	-46.84 (-62.86 to -24.46)	0.55 (-34.45 to 34.22)	-34.42 (-46.74 to 25.82)

Population analysed: 1 Subject in the "Diet/Exercise plus Metformin, then Diet/Exercise (Pubertal)" Group and 1 Subject in the "Diet/Exercise, then Diet/Exercise plus Metformin (Pubertal)" Group did not have a PAI-1 level available for analysis.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diet/Exercise Only, Then Diet/Exercise Plus Metformin	0 of 31 (0%)	0 of 31 (0%)	Not reported
Diet/Exercise Plus Metformin, Then Diet/Exercise Only	0 of 35 (0%)	0 of 35 (0%)	Not reported

Limitations and caveats (from the sponsor): Protocol #2 attrition was high, such that, we could not derive conclusions beyond the 6 month time period. Therefore, conclusions were based on participants after completing the first intervention without crossover to the second intervention.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20061420Mauras N, Delgiorno C, Kollman C, Bird K, Morgan M, Sweeten S, Balagopal P, Damaso L. Obesity without established comorbidities of the metabolic syndrome is associated with a proinflammatory and prothrombotic state, even before the onset of puberty in children. J Clin Endocrinol Metab. 2010 Mar;95(3):1060-8. doi: 10.1210/jc.2009-1887. Epub 2010 Jan 8.
Results publication: PubMed 22015710Rynders C, Weltman A, Delgiorno C, Balagopal P, Damaso L, Killen K, Mauras N. Lifestyle intervention improves fitness independent of metformin in obese adolescents. Med Sci Sports Exerc. 2012 May;44(5):786-92. doi: 10.1249/MSS.0b013e31823cef5e.
Results publication: PubMed 22570948Mauras N, DelGiorno C, Hossain J, Bird K, Killen K, Merinbaum D, Weltman A, Damaso L, Balagopal P. Metformin use in children with obesity and normal glucose tolerance--effects on cardiovascular markers and intrahepatic fat. J Pediatr Endocrinol Metab. 2012;25(1-2):33-40. doi: 10.1515/jpem-2011-0450.
Derived from this study: PubMed 22819275Benson M, Hossain J, Caulfield MP, Damaso L, Gidding S, Mauras N. Lipoprotein subfractions by ion mobility in lean and obese children. J Pediatr. 2012 Dec;161(6):997-1003. doi: 10.1016/j.jpeds.2012.05.060. Epub 2012 Jul 20.

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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.

Nelly Mauras, MD principal investigator

Nemours Children's Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Metformin, Dietary modification with caloric restriction and Establishment of exercise protocol in people with Obesity, run by Nemours Children's Clinic 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 10 inclusion and 11 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 18 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 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?

Yes. Results are posted in the registry (first posted 11 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 From Baseline in High-sensitivity C-reactive Protein (hsCRP) at 6 Months (time frame: Baseline and 6 months). The study lists 4 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 NCT00139477, which also lists 4 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 18 Apr 2023.