Diabetes Mellitus, Type 2NCT06146036
Effects of Different ''Exercise Snacking'' Modalities on Glycemic Control in Patients With Type 2 Diabetes
A study testing HIIT snacks and Sprint snacks in people with Diabetes Mellitus, Type 2 and Overweight or Obesity, run by University of Nis.
Trial summary
Patients with type 2 diabetes (T2DM) face an increased risk of obesity, hypertension, and hyperglycemia, attributed to impaired cardiorespiratory fitness, elevated Hb1AC levels, and impaired lipid status. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Overweight or Obesity
- What is being tested?
- HIIT snacks and Sprint snacks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2024to 15 Mar 2024
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-45 years old patients who have been diagnosed with Type 2 diabetes at least 3 months prior to the start of the study according to standard criteria
- BMI between 25 and 35 kg/m2 Inactive patients according to the International Physical Activity Questionnaire
- patients receiving medical therapy (no more than two medications) and not undergoing exogenous insulin therapy
- patients free of injuries and without any contraindications to exercise or chronic diseases that might be disruptive with vigorous activity
- patients should be stable on their current diabetes medications, with no recent changes in their treatment regimen
Who cannot join
- patients undergoing exogenous insulin therapy or/and receiving more than two glucose-lowering medicaments
- highly physically active on the International Physical Activity Questionnaire (IPAQ)
- patients suffering from any of the ''end-stage'' chronic diseases including: renal disease, liver disease, neuropathy, cardiovascular diseases uncontrolled hypertension
- patients who are strictly prohibited by medical professionals from engaging in vigorous exercise
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Comparison of the Acute Effects of Two ''Exercise Snacking'' Modalities on Glycemic Control in Overweight Patients With Type 2 Diabetes
Patients with type 2 diabetes (T2DM) face an increased risk of obesity, hypertension, and hyperglycemia, attributed to impaired cardiorespiratory fitness, elevated Hb1AC levels, and impaired lipid status. Therefore, effective prevention of complications and T2DM-related diseases is crucial for increasing the life expectancy of T2DM patients. Regular exercise plays a crucial role in the prevention and management of diabetes and its associated complications. However, most T2DM patients are not engaged in exercise. The most common causes are a lack of time, monotonous training patterns, and the severe exhaustion patients experience after recently developed and effective HIIT and SIT programs. Therefore, recent studies have explored the concept of "exercise snacking" (brief isolated bouts (< 1 min) of intense exercise spread throughout the day
) as a promising strategy to improve glycemic control, functional capacity, and cardiometabolic health among clinical and healthy populations. However, the type, intensity, and volume of exercise bouts that result in the best improvement are unknown. Therefore, we hypothesize that these exercise modalities may also acutely improve glycaemic control in sedentary overweight patients with T2DM.
- This study will examine the acute impact of two modalities of ''Exercise Snacking'', compared with a no-exercise control (CON), on glycemic control and blood pressure
- Compare the acute effects of two ''Exercise Snacking'' modalities
- Collect data on individuals' perceptions of each workout mode using measures of Rate of Perceived Exertion (RPE), enjoyment, affect, and adverse events
Read the detailed description
A randomized crossover design will be used for the acute effects study.
Prior to the experimental protocols, participants will be asked to come to the lab on four separate days, which will be scheduled to meet individual schedules.
Day one An electrocardiography stress test (ECG) test will be performed to assess if participants could enroll in the study. The test will be conducted, monitored, and reviewed by a Cardiologist and written approval will be necessary for further inclusion in the study. Moreover, during the first visit a continuous glucose monitoring (iCGM) device - will be inserted on the participant's non-dominant upper arm according to the manual guidelines. The accuracy of the iCGM devices will be validated using capillary vs interstitial iCGM measurements.
Day two The participants will be tested for anthropometric characteristics (height), and body composition. This procedure is necessary to determine the BMI most validly. All tests will be conducted in the laboratory of the Faculty of Sports and Physical Education.
Day three The maximal incremental test on the cycle ergometer will be used to determine the cardiorespiratory fitness level (VO2max, VO2peak) as well as the resting heart rate (HRrest), maximum HR (HRmax), and HR recovery (HRRTEST). These parameters, primarily HRmax will be crucial when implementing the intensity of the session which will not be done in an ''all effort'' manner. Participants will be familiarized with wearing the heart rate monitors and using the rating of perceived exertion scale (RPE) too. Briefly, after a 5-minute warm-up at 50 W, the intensity will be increased by 15 W/min until the tempo can no longer be maintained at 50 rpm. Cardiorespiratory fitness will be measured using an online gas analysis system (Cosmed Quark; CPET, Rome, Italy), VO2peak will be determined as the highest ten-breath rolling average and accepted if two or more of the following criteria were met: (1) voluntary exhaustion, (2) a plateau in VO2 despite increasing intensity; (3) maximal heart rate within 10 beats of the age-predicted maximum. This protocol already has been used in patients with T2DM.
Day four On the fourth day, the familiarization process will be conducted. Briefly, participants will be given the opportunity to try on the exercise sessions that we will use in the main protocols.
Main experimental protocols Before each trial participants will be asked to avoid any strenuous exercise at least for 72 hours. After 7 days of baseline assessment, participants will come to the laboratory. Each of these trials will be separated by at least 5-7 days. Before and after each protocol blood glucose levels (SBP and DPB) will be measured, as well as RPE, enjoyment, affect, and adverse events using the standardized questionaries and rating scales. Moreover, HR will be measured continuously during each exercise session.
- Participants will come to the laboratory three times a day and the protocols will not last longer than half an hour. Therefore, after a short-term warm-up on the cycle ergometer (5 minutes, the intensity was determined by the participants themselves), short-term, intense bouts of cycling 6x1 minute at 90% HR max with a minute of active break between bouts will be performed (at 50 W). Recovery will last 3 minutes, also at the self-paced. The whole process will be repeated two more times during the day with intervals of 1-4 hours
- For the SS group, training will consist of three separate sprints on the cycle ergometer separated by 1-4 h. The SS exercise bouts will consist of a 2-minute warm-up followed by a 20-s sprint and then a 1-minute cooldown (three separate workout sessions each lasting 3 min 20 s). The warm-up, cooldown, and recovery periods will all be performed at 50 W. Each sprint will be performed at a resistance of 0.21 N m/kg and include a 10-s period when participants will be advised to accelerate the number of rpm as fast as possible.
- Control - During CON, participants will come to the lab and remain sedentary throughout this entire period.
- Conditions
- Diabetes Mellitus, Type 2, Overweight or Obesity
- Being tested
- HIIT snacks, Sprint snacks, Control
- Keywords
- exercise, high intensity, diabetes melitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIIT snacksBehavioural
Cycling Exercise. 3 times per day 6 x 1 min at approximately 85-95% of HRmax
Sprint snacksBehavioural
Cycling Exercise. 3 times per day one ''all out'' sprint
ControlOther
No exercise, sedentary.
| Study group | Role | What they receive |
|---|---|---|
| HIIT snacks | Experimental | 3 x 6×1 minute cycling intervals at 90% at HRmax Receives: Behavioral: HIIT snacks |
| Sprint snaks | Experimental | 3×20-second 'all-out' cycling with 1-4 hours recovery between sprints Receives: Behavioral: Sprint snacks |
| Control | Experimental | No exercise. Rest. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean 24-hour blood glucose levels
Blood glucose levels (mmol/L) will be measured continuously using continuous glucose monitoring system under free-living conditions without providing standardized meals
Measured: At baseline (visit 1, week 1) and through main experimental period (visit 5 , week 2, visit 6 - week 3 and visit 7 - week 4).
Time spent in hyperglycemia
The % of the day spent above 10 mmol/L within 24 hours will be calculated using continuous glucose monitoring system under free-living conditions without providing standardized meals.
Measured: At baseline (visit 1, week 1) and through main experimental period (visit 5 , week 2, visit 6 - week 3 and visit 7 - week 4).
Glycemic variability
Glycemic variability will be measured using the mean amplitude of glycemic excursions (MAGE) and standard deviation (SD) from mean glucose.
Measured: At baseline (visit 1, week 1) and through main experimental period (visit 5 , week 2, visit 6 - week 3 and visit 7 - week 4).
Incremental Area Under the Curve (AUC)
The incremental area under the curve for the glucose response will be calculated using trapezoidal model.
Measured: At baseline (visit 1, week 1) and through main experimental period (visit 5 , week 2, visit 6 - week 3 and visit 7 - week 4).
Secondary outcomes (5)
Ratings of perceived exertion (RPE)
RPE will be examined using Borg Scale (0-10 scale) with 1 being ,,very light'' and 10 being ''maximum effort''.
Measured: RPE will be examined before and after each exercise session during main experimental period.
Adverse events
Adverse events will be evaluated and classified into four different categories: 1) minor and temporary, 2) serious symptoms (potential risk of severe injury or life threatening, 3) manifest injury or disease and 4) death. An adverse event rate will be calculated for each participant as the total number of sessions during which any adverse events occurred divided by the total number of attended sessions.
Measured: Adverse events will be assessed through main experimental period (visit 5 , week 2; visit 6 - week 3; visit 7 - week 4)
Exercise enjoyment
The Physical Activity Enjoyment Scale (PACES) will be used to determine the perceived enjoyment after each exercise session. The PACES is an 18-item physical activity/exercise enjoyment scale in which participants are asked to rate "how you feel at the moment about the physical activity/exercise you have been doing" on a 7-point bipolar Likert scale with a total score of 126. Higher scores indicate greater levels of the exercise enjoyment.
Measured: Will be assessed immediately after each exercise session during main experimental period.
Changes in positive and negative affect
Changes in positive and negative affect as a result of the exercise bouts will be measured using the positive and negative affect scale (PANAS). The PANAS consists of 20 items, with 10 items measuring positive affect and 10 items measuring negative affect on a 5-point Likert scale. Higher scores indicate higher levels of positive affect.
Measured: Changes in positive and negative affect will be measured before and after each exercise session during main experimental period.
Blood pressure
Both systolic (SBP) and diastolic blood pressure (DBP) will be measured.
Measured: SBP and DBP will be measured at baseline before and after each exercise session during main experimental period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start20 Jan 2024 (estimated)
- Primary completion20 Feb 2024 (estimated)
- Study completion15 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anja Lazić, University of Nis
- Investigators
- Milica Pesic, PhD, Study director, Medical Faculty, University of Nis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146036
- Sponsor's protocol ID
- To snack or not to snack
- Status last verified
- Dec 2023
- First submitted
- 13 Nov 2023
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lazic A, Dankovic G, Korobeinikov G, Cadenas-Sanchez C, Trajkovic N. Acute effects of different "exercise snacking'' modalities on glycemic control in patients with type 2 diabetes mellitus (T2DM): study protocol for a randomized controlled trial. BMC Public Health. 2025 Feb 11;25(1):566. doi: 10.1186/s12889-025-21669-9.
PubMed 39934727
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Acute Effects of Two ''Exercise Snacking'' Modalities on Glycemic Control in Overweight Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06146036
- Acronym / sponsor ID
- To snack or not to snack
- Conditions
- Diabetes Mellitus, Type 2, Overweight or Obesity
- Keywords
- exercise, high intensity, diabetes melitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of NisUniversity, hospital or other
- Study start
- 20 Jan 2024 (estimated)
- Primary completion
- 20 Feb 2024 (estimated)
- Study completion
- 15 Mar 2024 (estimated)
- First posted
- 24 Nov 2023 (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.
Patients with type 2 diabetes (T2DM) face an increased risk of obesity, hypertension, and hyperglycemia, attributed to impaired cardiorespiratory fitness, elevated Hb1AC levels, and impaired lipid status. Therefore, effective prevention of complications and T2DM-related diseases is crucial for increasing the life expectancy of T2DM patients. Regular exercise plays a crucial role in the prevention and management of diabetes and its associated complications. However, most T2DM patients are not engaged in exercise. The most common causes are a lack of time, monotonous training patterns, and the severe exhaustion patients experience after recently developed and effective HIIT and SIT programs. Therefore, recent studies have explored the concept of "exercise snacking" (brief isolated bouts (< 1 min) of intense exercise spread throughout the day
) as a promising strategy to improve glycemic control, functional capacity, and cardiometabolic health among clinical and healthy populations. However, the type, intensity, and volume of exercise bouts that result in the best improvement are unknown. Therefore, we hypothesize that these exercise modalities may also acutely improve glycaemic control in sedentary overweight patients with T2DM.
- This study will examine the acute impact of two modalities of ''Exercise Snacking'', compared with a no-exercise control (CON), on glycemic control and blood pressure
- Compare the acute effects of two ''Exercise Snacking'' modalities
- Collect data on individuals' perceptions of each workout mode using measures of Rate of Perceived Exertion (RPE), enjoyment, affect, and adverse events
Detailed description
A randomized crossover design will be used for the acute effects study.
Prior to the experimental protocols, participants will be asked to come to the lab on four separate days, which will be scheduled to meet individual schedules.
Day one An electrocardiography stress test (ECG) test will be performed to assess if participants could enroll in the study. The test will be conducted, monitored, and reviewed by a Cardiologist and written approval will be necessary for further inclusion in the study. Moreover, during the first visit a continuous glucose monitoring (iCGM) device - will be inserted on the participant's non-dominant upper arm according to the manual guidelines. The accuracy of the iCGM devices will be validated using capillary vs interstitial iCGM measurements.
Day two The participants will be tested for anthropometric characteristics (height), and body composition. This procedure is necessary to determine the BMI most validly. All tests will be conducted in the laboratory of the Faculty of Sports and Physical Education.
Day three The maximal incremental test on the cycle ergometer will be used to determine the cardiorespiratory fitness level (VO2max, VO2peak) as well as the resting heart rate (HRrest), maximum HR (HRmax), and HR recovery (HRRTEST). These parameters, primarily HRmax will be crucial when implementing the intensity of the session which will not be done in an ''all effort'' manner. Participants will be familiarized with wearing the heart rate monitors and using the rating of perceived exertion scale (RPE) too. Briefly, after a 5-minute warm-up at 50 W, the intensity will be increased by 15 W/min until the tempo can no longer be maintained at 50 rpm. Cardiorespiratory fitness will be measured using an online gas analysis system (Cosmed Quark; CPET, Rome, Italy), VO2peak will be determined as the highest ten-breath rolling average and accepted if two or more of the following criteria were met: (1) voluntary exhaustion, (2) a plateau in VO2 despite increasing intensity; (3) maximal heart rate within 10 beats of the age-predicted maximum. This protocol already has been used in patients with T2DM.
Day four On the fourth day, the familiarization process will be conducted. Briefly, participants will be given the opportunity to try on the exercise sessions that we will use in the main protocols.
Main experimental protocols Before each trial participants will be asked to avoid any strenuous exercise at least for 72 hours. After 7 days of baseline assessment, participants will come to the laboratory. Each of these trials will be separated by at least 5-7 days. Before and after each protocol blood glucose levels (SBP and DPB) will be measured, as well as RPE, enjoyment, affect, and adverse events using the standardized questionaries and rating scales. Moreover, HR will be measured continuously during each exercise session.
- Participants will come to the laboratory three times a day and the protocols will not last longer than half an hour. Therefore, after a short-term warm-up on the cycle ergometer (5 minutes, the intensity was determined by the participants themselves), short-term, intense bouts of cycling 6x1 minute at 90% HR max with a minute of active break between bouts will be performed (at 50 W). Recovery will last 3 minutes, also at the self-paced. The whole process will be repeated two more times during the day with intervals of 1-4 hours
- For the SS group, training will consist of three separate sprints on the cycle ergometer separated by 1-4 h. The SS exercise bouts will consist of a 2-minute warm-up followed by a 20-s sprint and then a 1-minute cooldown (three separate workout sessions each lasting 3 min 20 s). The warm-up, cooldown, and recovery periods will all be performed at 50 W. Each sprint will be performed at a resistance of 0.21 N m/kg and include a 10-s period when participants will be advised to accelerate the number of rpm as fast as possible.
- Control - During CON, participants will come to the lab and remain sedentary throughout this entire period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIIT snacks | Experimental | Behavioral: HIIT snacks3 x 6×1 minute cycling intervals at 90% at HRmax |
| Sprint snaks | Experimental | Behavioral: Sprint snacks3×20-second 'all-out' cycling with 1-4 hours recovery between sprints |
| Control | Experimental | Other: ControlNo exercise. Rest. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-45 years old patients who have been diagnosed with Type 2 diabetes at least 3 months prior to the start of the study according to standard criteria
- BMI between 25 and 35 kg/m2 Inactive patients according to the International Physical Activity Questionnaire
- patients receiving medical therapy (no more than two medications) and not undergoing exogenous insulin therapy
- patients free of injuries and without any contraindications to exercise or chronic diseases that might be disruptive with vigorous activity
- patients should be stable on their current diabetes medications, with no recent changes in their treatment regimen
Key exclusion criteria (4 listed)
- patients undergoing exogenous insulin therapy or/and receiving more than two glucose-lowering medicaments
- highly physically active on the International Physical Activity Questionnaire (IPAQ)
- patients suffering from any of the ''end-stage'' chronic diseases including: renal disease, liver disease, neuropathy, cardiovascular diseases uncontrolled hypertension
- patients who are strictly prohibited by medical professionals from engaging in vigorous exercise
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 |
|---|---|---|
| HIIT snacksCycling Exercise. 3 times per day 6 x 1 min at approximately 85-95% of HRmax | Behavioural | HIIT snacks |
| Sprint snacksCycling Exercise. 3 times per day one ''all out'' sprint | Behavioural | Sprint snaks |
| ControlNo exercise, sedentary. | Other | Control |
Primary outcome
Mean 24-hour blood glucose levels
Time frame: At baseline (visit 1, week 1) and through main experimental period (visit 5 , week 2, visit 6 - week 3 and visit 7 - week 4).
Blood glucose levels (mmol/L) will be measured continuously using continuous glucose monitoring system under free-living conditions without providing standardized meals
Time spent in hyperglycemia
Time frame: At baseline (visit 1, week 1) and through main experimental period (visit 5 , week 2, visit 6 - week 3 and visit 7 - week 4).
The % of the day spent above 10 mmol/L within 24 hours will be calculated using continuous glucose monitoring system under free-living conditions without providing standardized meals.
Glycemic variability
Time frame: At baseline (visit 1, week 1) and through main experimental period (visit 5 , week 2, visit 6 - week 3 and visit 7 - week 4).
Glycemic variability will be measured using the mean amplitude of glycemic excursions (MAGE) and standard deviation (SD) from mean glucose.
Incremental Area Under the Curve (AUC)
Time frame: At baseline (visit 1, week 1) and through main experimental period (visit 5 , week 2, visit 6 - week 3 and visit 7 - week 4).
The incremental area under the curve for the glucose response will be calculated using trapezoidal model.
5 secondary outcomes
Ratings of perceived exertion (RPE)
Time frame: RPE will be examined before and after each exercise session during main experimental period.
Adverse events
Time frame: Adverse events will be assessed through main experimental period (visit 5 , week 2; visit 6 - week 3; visit 7 - week 4)
Exercise enjoyment
Time frame: Will be assessed immediately after each exercise session during main experimental period.
Changes in positive and negative affect
Time frame: Changes in positive and negative affect will be measured before and after each exercise session during main experimental period.
Blood pressure
Time frame: SBP and DBP will be measured at baseline before and after each exercise session during main experimental period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Derived from this study: PubMed 39934727Lazic A, Dankovic G, Korobeinikov G, Cadenas-Sanchez C, Trajkovic N. Acute effects of different "exercise snacking'' modalities on glycemic control in patients with type 2 diabetes mellitus (T2DM): study protocol for a randomized controlled trial. BMC Public Health. 2025 Feb 11;25(1):566. doi: 10.1186/s12889-025-21669-9.
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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.
Milica Pesic, PhD study director
Medical Faculty, University of Nis
Questions about this trial
What is this clinical trial studying?
A study testing HIIT snacks and Sprint snacks in people with Diabetes Mellitus, Type 2 and Overweight or Obesity, run by University of Nis.
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 4 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: status not confirmed, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nebojsa Trajkovic, PhD (+381652070462, nele_trajce@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean 24-hour blood glucose levels (time frame: At baseline (visit 1, week 1) and through main experimental period (visit 5 , week 2, visit 6 - week 3 and visit 7 - week 4).). 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 NCT06146036, which also lists 1 linked publication.
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 22 Dec 2023.