Diabetes Mellitus, Type 2NCT03952000
Influence of Prior Walking on Postprandial Metabolism in Centrally Obese Men
A study testing Exercise in people with Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Loughborough University at 1 site in United Kingdom.
Trial summary
The present study will investigate the effect of prior walking on postprandial metabolism and endothelial function in centrally obese South Asian and White European men. Participants will complete two, 2-day trials in a random, crossover design separated by at least a week. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Cardiovascular Diseases, Endothelial Dysfunction
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Jan 2019to 1 Sep 2019
- Phase
- Interventional
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 60 year old South Asian and White European men;
- Centrally obese (waist circumference >90cm for South Asians, >94cm for White Europeans);
- Weight stable for the past 3 months;
- Non-smokers;
- No known contradictions to maximal exertion exercise.
Who cannot join
- Musculoskeletal injury that has affected normal ambulation within the last month;
- Congenital heart disease;
- Any muscle or bone injuries that do not allow them to walk on a treadmill;
- Uncontrolled exercise-induced asthma;
- Coagulation or bleeding disorders;
- Diabetes (metabolism will be different to non-diabetics potentially skewing the data);
Show all 13Show fewer
- Taking any medication that might influence fat metabolism;
- Taking any medication that might influence blood glucose (e.g., insulin for diabetes);
- Heart conditions;
- Smoking;
- Dieting or restrained eating behaviours;
- Weight fluctuation greater than 3 kg in the previous 3 months to study enrolment;
- A food allergy.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
National Centre for Sport and Exercise Medicine, Loughborough University
Loughborough, LE11 3TU
About this study
Official title: Influence of Prior Walking on Endothelial Function and Coronary Heart Disease Risk Markers in Centrally Obese South Asian and White European Men
The present study will investigate the effect of prior walking on postprandial metabolism and endothelial function in centrally obese South Asian and White European men.
Participants will complete two, 2-day trials in a random, crossover design separated by at least a week.
Read more
On day 1, participants will either rest or complete a 60 minute walk at 60% maximal oxygen uptake. On day 2, participants will arrive at 08:00 having fasted overnight and a baseline venous blood sample and endothelial function measurement will be taken. Participants will consume a high-fat breakfast and lunch and 12 subsequent venous blood samples will be taken throughout the day at standardised intervals to measure a variety of coronary heart disease risk markers. A second endothelial function measurement will be completed 2 hours after the breakfast. Blood pressure will be measured every hour.
It is expected that the South Asian participants will have impaired metabolism and endothelial function compared to their European counterparts but the bout of exercise performed on day 1 will mitigate these responses.
Read the detailed description
South Asians have a higher-than-average risk of coronary heart disease. The reasons for this are unclear, but physical inactivity and/or poor responsiveness to exercise may play a role. It is important to understand the effect of exercise on endothelial function and coronary heart disease risk markers in the hope that exercise can be prescribed as an effective treatment to mitigate endothelial dysfunction and the risk of heart disease.
Previous research from the investigators' laboratory has indicated that postprandial metabolism is impaired in South Asian men, but this, and other coronary heart disease risk markers, can be improved with acute exercise. However, the previous research was conducted in apparently healthy South Asian and White European men. The investigators now wish to quantify and compare the coronary heart disease risk marker and endothelial function response to acute exercise in centrally obese South Asian and White European individuals who are at a higher risk for diabetes and cardiovascular disease.
On visit 1, participants will attend the laboratory to undergo preliminary assessments and to be familiarised with the laboratory environment and study procedures. Specifically, health status, habitual physical activity, dietary habits and anthropometric data (height, weight, waist and hip circumference, body fat) will be collected. A HbA1c test will be performed to check participants are not diabetic. The modified Bruce Treadmill test will be performed to predict maximal oxygen uptake.
On visit 2, participants will undergo a magnetic resonance imaging (MRI) scan to quantify regional body composition comprising abdominal subcutaneous adipose tissue, visceral adipose tissue, liver fat percentage, thigh intramuscular adipose tissue and thigh muscle volume.
On visits 3-6 participants will complete two, 2-day trials in a random, crossover design separated by at least 1 week. On day 1 of both trials, participants will arrive fasted at 08:00 and a baseline blood sample, blood pressure and endothelial function measurement will be taken. Participants will consume a standardised high fat breakfast at 09:00 and lunch at 13:00. At 15:30 the participants will walk for 60 minutes at 60% maximal oxygen uptake and complete a second endothelial function measurement at 16:45. Participants will leave the laboratory with a standardised evening meal to consume before 22:00. The control trial will be the same, except no exercise will be performed.
On day 2, participants will arrive at 08:00 having fasted overnight for 10h (except plain water). A cannula will be inserted into the antecubital vein for collection of venous blood samples. Blood pressure will be measured at 08:00 (0h) and again at hourly intervals throughout the day. Endothelial function will measured at 08:15 (0.25h) and again at 3h. At 0h, a fasting blood sample will be collected. Subsequent venous blood samples will be collected at 1.5, 1.75, 2, 3, 4, 5, 5.5, 5.75, 6, 7, 8 and 9h. Participants will consume a standardised high fat breakfast at 1h and a standardised high fat lunch at 5h. The meals consist of 57% fat, 32% carbohydrate and 11% protein. The meals provide 14.3 kcal per kg of body mass.
Participants will rest in the laboratory throughout day 2 of both the exercise and control trials.
- Conditions
- Diabetes Mellitus, Type 2, Cardiovascular Diseases, Endothelial Dysfunction, Insulin Resistance, Oxidative Stress
- Being tested
- Exercise
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
A 60 minute walk at 60% maximal oxygen uptake.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Exercise | Experimental | Exercise: Participants will walk for 60 minutes at 60% maximal oxygen uptake on day 1. Receives: Behavioral: Exercise |
| No Intervention: Control | No intervention | Participants will rest on day 1. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triacylglycerol changes in response to exercise and feeding
Fasting on day 1 and 2. Time-course of plasma triacylglycerol concentrations in response to exercise and/or feeding on day 2.
Measured: Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 1.75hours, 2hours, 3hours, 4hours, 5hours, 5.5hours, 5.75hours, 6hours, 7hours, 8hours and 9hours.
Endothelial function changes in response to exercise and feeding
Changes in endothelial function via flow-mediated dilatation in response to feeding and exercise.
Measured: Day 1 fasting and 8.75hours. Day 2 fasting and 2.5hours.
Secondary outcomes (12)
Glucose changes in response to exercise and/or feeding
Fasting on day 1 and 2. Time-course of plasma glucose concentrations in response to exercise and/or feeding on day 2.
Measured: Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 1.75hours, 2hours, 3hours, 4hours, 5hours, 5.5hours, 5.75hours, 6hours, 7hours, 8hours and 9hours.
Blood pressure changes in response to exercise and/or feeding
Changes in blood pressure (systolic and diastolic).
Measured: Day 1 fasting. Day 2 fasting (0 hour point) and 1hours, 2hours, 3hours, 4hours, 5hours, 6hours, 7hours, 8hours and 9hours.
Total cholesterol
Fasting plasma total cholesterol on day 1 and day 2 of both trials.
Measured: Day 1 fasting. Day 2 fasting.
Insulin changes in response to exercise and/or feeding
Fasting on day 1 and 2. Time-course of plasma insulin concentrations in response to exercise and/or feeding on day 2.
Measured: Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 2hours, 4hours, 5hours, 5.5hours, 7hours, 8hours.
High-density lipoprotein cholesterol
Fasting high-density lipoprotein cholesterol on day 1 and 2 of both trials.
Measured: Day 1 fasting. Day 2 fasting.
Low-density lipoprotein cholesterol
Fasting low-density lipoprotein cholesterol on day 1 and 2 of both trials.
Measured: Day 1 fasting. Day 2 fasting.
Non-esterified fatty acids changes in response to exercise and/or feeding
Fasting on day 1 and 2. Time-course of plasma non-esterified fatty acid concentrations in response to exercise and/or feeding on day 2.
Measured: Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 2hours, 4hours, 5hours, 5.5hours, 7hours and 9hours.
Interleukin-6 changes in response to exercise and/or feeding
Fasting on day 1 and 2. Time-course of plasma interleukin-6 concentrations in response to exercise and/or feeding on day 2.
Measured: Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.
C-Reactive protein changes in response to exercise and/or feeding
Fasting on day 1 and 2. Time-course of plasma C-Reactive protein concentrations in response to exercise and/or feeding on day 2.
Measured: Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.
Tumor Necrosis Factor concentrations
Fasting tumor necrosis factor on day 1 and 2 of both trials.
Measured: Day 1 fasting. Day 2 fasting.
Peroxiredoxin-4 changes in response to exercise and/or feeding
Fasting on day 1 and 2. Time-course of plasma peroxiredoxin-4 concentrations across day 2 of both trials.
Measured: Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.
Superoxide dismutase 3
Fasting on day 1 and 2. Time-course of plasma Superoxide dismutase 3 concentrations across day 2 of both trials
Measured: Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start3 Jan 2019
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester
- Responsible party
- Principal investigator, Matthew Roberts, Loughborough University
- Investigators
- David Stensel, Principal investigator, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952000
- Sponsor's protocol ID
- R18-P120
- Status last verified
- Jan 2020
- First submitted
- 13 May 2019
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised individual participant data for all primary and secondary outcome measures will be made available upon request. Study protocol, statistical analysis plan and informed consent forms are also available upon request.
Publications
Arjunan SP, Deighton K, Bishop NC, King J, Reischak-Oliveira A, Rogan A, Sedgwick M, Thackray AE, Webb D, Stensel DJ. The effect of prior walking on coronary heart disease risk markers in South Asian and European men. Eur J Appl Physiol. 2015 Dec;115(12):2641-51. doi: 10.1007/s00421-015-3269-7. Epub 2015 Oct 5.
PubMed 26438068Arjunan SP, Bishop NC, Reischak-Oliveira A, Stensel DJ. Exercise and coronary heart disease risk markers in South Asian and European men. Med Sci Sports Exerc. 2013 Jul;45(7):1261-8. doi: 10.1249/MSS.0b013e3182853ecf.
PubMed 23470315
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Prior Walking on Endothelial Function and Coronary Heart Disease Risk Markers in Centrally Obese South Asian and White European Men
- ClinicalTrials.gov ID
- NCT03952000
- Acronym / sponsor ID
- R18-P120
- Conditions
- Diabetes Mellitus, Type 2, Cardiovascular Diseases, Endothelial Dysfunction, Insulin Resistance, Oxidative Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 16 May 2019 (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.
The present study will investigate the effect of prior walking on postprandial metabolism and endothelial function in centrally obese South Asian and White European men.
Participants will complete two, 2-day trials in a random, crossover design separated by at least a week.
On day 1, participants will either rest or complete a 60 minute walk at 60% maximal oxygen uptake. On day 2, participants will arrive at 08:00 having fasted overnight and a baseline venous blood sample and endothelial function measurement will be taken. Participants will consume a high-fat breakfast and lunch and 12 subsequent venous blood samples will be taken throughout the day at standardised intervals to measure a variety of coronary heart disease risk markers. A second endothelial function measurement will be completed 2 hours after the breakfast. Blood pressure will be measured every hour.
It is expected that the South Asian participants will have impaired metabolism and endothelial function compared to their European counterparts but the bout of exercise performed on day 1 will mitigate these responses.
Detailed description
South Asians have a higher-than-average risk of coronary heart disease. The reasons for this are unclear, but physical inactivity and/or poor responsiveness to exercise may play a role. It is important to understand the effect of exercise on endothelial function and coronary heart disease risk markers in the hope that exercise can be prescribed as an effective treatment to mitigate endothelial dysfunction and the risk of heart disease.
Previous research from the investigators' laboratory has indicated that postprandial metabolism is impaired in South Asian men, but this, and other coronary heart disease risk markers, can be improved with acute exercise. However, the previous research was conducted in apparently healthy South Asian and White European men. The investigators now wish to quantify and compare the coronary heart disease risk marker and endothelial function response to acute exercise in centrally obese South Asian and White European individuals who are at a higher risk for diabetes and cardiovascular disease.
On visit 1, participants will attend the laboratory to undergo preliminary assessments and to be familiarised with the laboratory environment and study procedures. Specifically, health status, habitual physical activity, dietary habits and anthropometric data (height, weight, waist and hip circumference, body fat) will be collected. A HbA1c test will be performed to check participants are not diabetic. The modified Bruce Treadmill test will be performed to predict maximal oxygen uptake.
On visit 2, participants will undergo a magnetic resonance imaging (MRI) scan to quantify regional body composition comprising abdominal subcutaneous adipose tissue, visceral adipose tissue, liver fat percentage, thigh intramuscular adipose tissue and thigh muscle volume.
On visits 3-6 participants will complete two, 2-day trials in a random, crossover design separated by at least 1 week. On day 1 of both trials, participants will arrive fasted at 08:00 and a baseline blood sample, blood pressure and endothelial function measurement will be taken. Participants will consume a standardised high fat breakfast at 09:00 and lunch at 13:00. At 15:30 the participants will walk for 60 minutes at 60% maximal oxygen uptake and complete a second endothelial function measurement at 16:45. Participants will leave the laboratory with a standardised evening meal to consume before 22:00. The control trial will be the same, except no exercise will be performed.
On day 2, participants will arrive at 08:00 having fasted overnight for 10h (except plain water). A cannula will be inserted into the antecubital vein for collection of venous blood samples. Blood pressure will be measured at 08:00 (0h) and again at hourly intervals throughout the day. Endothelial function will measured at 08:15 (0.25h) and again at 3h. At 0h, a fasting blood sample will be collected. Subsequent venous blood samples will be collected at 1.5, 1.75, 2, 3, 4, 5, 5.5, 5.75, 6, 7, 8 and 9h. Participants will consume a standardised high fat breakfast at 1h and a standardised high fat lunch at 5h. The meals consist of 57% fat, 32% carbohydrate and 11% protein. The meals provide 14.3 kcal per kg of body mass.
Participants will rest in the laboratory throughout day 2 of both the exercise and control trials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Exercise | Experimental | Behavioral: ExerciseExercise: Participants will walk for 60 minutes at 60% maximal oxygen uptake on day 1. |
| No Intervention: Control | No intervention | –Participants will rest on day 1. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18 to 60 year old South Asian and White European men;
- Centrally obese (waist circumference >90cm for South Asians, >94cm for White Europeans);
- Weight stable for the past 3 months;
- Non-smokers;
- No known contradictions to maximal exertion exercise.
Key exclusion criteria (13 listed)
- Musculoskeletal injury that has affected normal ambulation within the last month;
- Congenital heart disease;
- Any muscle or bone injuries that do not allow them to walk on a treadmill;
- Uncontrolled exercise-induced asthma;
- Coagulation or bleeding disorders;
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 |
|---|---|---|
| ExerciseA 60 minute walk at 60% maximal oxygen uptake. | Behavioural | Experimental: Exercise |
Primary outcome
Triacylglycerol changes in response to exercise and feeding
Time frame: Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 1.75hours, 2hours, 3hours, 4hours, 5hours, 5.5hours, 5.75hours, 6hours, 7hours, 8hours and 9hours.
Fasting on day 1 and 2. Time-course of plasma triacylglycerol concentrations in response to exercise and/or feeding on day 2.
Endothelial function changes in response to exercise and feeding
Time frame: Day 1 fasting and 8.75hours. Day 2 fasting and 2.5hours.
Changes in endothelial function via flow-mediated dilatation in response to feeding and exercise.
12 secondary outcomes
Glucose changes in response to exercise and/or feeding
Time frame: Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 1.75hours, 2hours, 3hours, 4hours, 5hours, 5.5hours, 5.75hours, 6hours, 7hours, 8hours and 9hours.
Blood pressure changes in response to exercise and/or feeding
Time frame: Day 1 fasting. Day 2 fasting (0 hour point) and 1hours, 2hours, 3hours, 4hours, 5hours, 6hours, 7hours, 8hours and 9hours.
Total cholesterol
Time frame: Day 1 fasting. Day 2 fasting.
Insulin changes in response to exercise and/or feeding
Time frame: Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 2hours, 4hours, 5hours, 5.5hours, 7hours, 8hours.
High-density lipoprotein cholesterol
Time frame: Day 1 fasting. Day 2 fasting.
Low-density lipoprotein cholesterol
Time frame: Day 1 fasting. Day 2 fasting.
Non-esterified fatty acids changes in response to exercise and/or feeding
Time frame: Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 2hours, 4hours, 5hours, 5.5hours, 7hours and 9hours.
Interleukin-6 changes in response to exercise and/or feeding
Time frame: Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.
C-Reactive protein changes in response to exercise and/or feeding
Time frame: Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.
Tumor Necrosis Factor concentrations
Time frame: Day 1 fasting. Day 2 fasting.
Peroxiredoxin-4 changes in response to exercise and/or feeding
Time frame: Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.
Superoxide dismutase 3
Time frame: Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.
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 29 Jan 2020.
- Background: PubMed 26438068Arjunan SP, Deighton K, Bishop NC, King J, Reischak-Oliveira A, Rogan A, Sedgwick M, Thackray AE, Webb D, Stensel DJ. The effect of prior walking on coronary heart disease risk markers in South Asian and European men. Eur J Appl Physiol. 2015 Dec;115(12):2641-51. doi: 10.1007/s00421-015-3269-7. Epub 2015 Oct 5.
- Background: PubMed 23470315Arjunan SP, Bishop NC, Reischak-Oliveira A, Stensel DJ. Exercise and coronary heart disease risk markers in South Asian and European men. Med Sci Sports Exerc. 2013 Jul;45(7):1261-8. doi: 10.1249/MSS.0b013e3182853ecf.
- Individual participant dataSharing planned: Yes. Anonymised individual participant data for all primary and secondary outcome measures will be made available upon request. Study protocol, statistical analysis plan and informed consent forms are also 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.
David Stensel principal investigator
Loughborough University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Loughborough University at 1 site in United Kingdom.
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 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 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Triacylglycerol changes in response to exercise and feeding (time frame: Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 1.75hours, 2hours, 3hours, 4hours, 5hours, 5.5hours, 5.75hours, 6hours, 7hours, 8hours and 9hours.). The study lists 2 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 NCT03952000, which also lists 2 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 29 Jan 2020.