DiabetesNCT06202950
Type 1 Diabetes,Mindfulness,Yoga,Stress,Health Quality,Glycemic İndex
A study testing Yoga and Mindfulness in people with Diabetes and Stress, run by Hasan Kalyoncu University at 2 sites in Turkey (Türkiye).
Trial summary
The study will examine the effects of Mindfulness-Based Stress Reduction Program and yoga on stress level, quality of life and glycemic control in Youth with Type 1 diabetes. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- What is being tested?
- Yoga and Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Mar 2023to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Youth with Type 1 diabetes between the ages of 13 and 18 with a diabetes age of at least 12 months
- Not having participated in a Mindfulness-Based Stress Reduction Program or doing yoga before,
- Speaking and understanding Turkish,
- Able to read and write,
- Having no other physiological or psychological diseases,
- No mental disability,
Show all 9Show fewer
- Not using psychoactive drugs,
- Parents volunteered for their child to participate in the research and signed the consent form,
- During the application phase, you should have eaten 1.5-2 hours before the application and your blood sugar should be between 150-200mg/dl before the application
Who cannot join
- Failed to complete the program
- Youth diagnosed with acute or chronic diseases in addition to diabetes during the study
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Emine Sarıkamış Kale
Batman, Merkez, 72000
Hasan Kalyoncu University
Gaziantep, Sahinbey
About this study
Official title: The Effect of Mindfulness and Yoga on Stress Level, Quality of Life and Glycemic Control in Youth With Type 1 Diabetes
The study will examine the effects of Mindfulness-Based Stress Reduction Program and yoga on stress level, quality of life and glycemic control in Youth with Type 1 diabetes.
Read the detailed description
Chronic disease; It is defined as a condition that causes permanent disability, is irreversible, occurs as a result of pathological changes, requires special training, long-term care, supervision and control for the rehabilitation of the patient, and limits daily functions. According to the World Health Organization (WHO) data on chronic diseases; Every year, 41 million people in the world die due to chronic diseases, and it is stated that these numbers correspond to 74% of the deaths in the world. Nowadays, chronic diseases are becoming an increasing health problem, especially for children and adolescents. According to WHO, the incidence of chronic diseases in adolescence is reported to be 15%. According to the report published by the American Academy of Pediatrics (APA), 10-20 million children and adolescents in the United States (USA) have some kind of chronic disease.Diabetes is one of the most common non-communicable chronic diseases globally. Diabetes Mellitus (DM) is a chronic metabolic disease that develops as a result of insufficiency, deficiency and/or absence of the insulin hormone secreted from beta cells in the pancreas, is characterized by hyperglycemia, and causes disorders in carbohydrate, fat and protein metabolism. It has a chronic course and is the most common metabolic disease in childhood. Although there are different types of diabetes, Type 1 diabetes is common in childhood. Type 1 diabetes cases constitute 10-15% of all diabetic patients, and this rate is increasing. Genetic, environmental and autoimmune factors play an important role in the development of Type 1 diabetes . The incidence of the disease, which is often seen between the ages of 7-15, increases between the ages of 4-6 and 10-14. According to the 10th Diabetes Atlas data published by the International Diabetes Federation in 2021; There are 536.6 million people with diabetes worldwide, and this number is expected to increase to 783.2 million in 2045. It is reported that the number of individuals with diabetes among children and adolescents between the ages of 0-19 worldwide is approximately 1.99 million, and 1.2 million of this number consists of children and adolescents with Type 1 diabetes. In our country, it is reported that the number of children and adolescents with Type 1 diabetes between the ages of 0-18 is approximately 17 thousand and the number of adolescents with diabetes between the ages of 10-18 is approximately 13 thousand.The fact that diabetes is a disease that is not easy to manage, combined with problems such as estrangement from parents in adolescence, increased sense of independence, physiological change and peer pressure, can cause many difficulties for the adolescent in fulfilling his developmental tasks.
In studies conducted with adolescents with type 1 diabetes; In the study to determine the quality of life of healthy children/adolescents with Type 1 diabetes aged 4-15, it was found that the quality of life of children and adolescents with Type 1 diabetes was lower than that of healthy children and adolescents.
In order to determine the time management skills of adolescents with Type 1 diabetes and the effect of these skills on metabolic control, another study with 69 adolescents with Type 1 diabetes between the ages of 13-19, using the Diabetes Adolescent Diagnosis Form, Diabetes Time Management Questionnaire (DBYA), Habits and Behaviors in Adaptation to Diabetes. In the research conducted using the and Information Survey (DUADBA), Metabolic Control and Daily Record Form; It has been stated that adolescents with good time management manage diabetes better and that managing diabetes well does not affect metabolic control.study applied the Psychological Symptom Screening Test (SCL-90-R) to 56 individuals with Type 1 diabetes between the ages of 7 and 21 in order to determine the psychological symptoms and findings of children and adolescents attending a diabetes camp. As a result of this research, "50.9% of the patients had somatization, 47.3% had anxiety, 43.9% had obsession, 33.3% had depression, 37.5% had psychosis, 48.2% had It was determined that there were multiple psychiatric findings, including anger in 100% of patients and phobia in 28.1%.In the study to examine the self-concept of children/adolescents with Type 1 diabetes and their ways of coping with stress; It has been stated that self-concept is higher in those with a short duration of diabetes or 11-15 years than in those with a diabetes duration of 6-10 years, and that coping with stress was found to be higher in adolescents aged 14-17 without Type 1 diabetes than in adolescents with diabetes .
In the research conducted with 349 adolescents with Type 1 diabetes and 409 healthy individuals between the ages of 6-18 from Kuwait, in order to examine the social and psychological conditions of children/adolescents; Depression and anxiety levels of children and adolescents with type 1 diabetes were found to be higher and their psychosocial relationships were worse.In a study to examine the symptoms of depression in adolescents with Type 1 diabetes, including 45 male and 72 female adolescents with Type 1 diabetes, depressive symptoms were found in 50% of the adolescents. It has also been reported that adolescents between the ages of 14 and 16 have more depressive symptoms than younger ones.
In the study which the coping skills with anxiety and glycemic control were investigated in adolescents with Type 1 diabetes, 145 individuals were studied and the Coping Inventory of Stressful Situations was applied. In this study, it was found that as the duration of the disease increases, anxiety decreases and the ability to cope with the disease increase.In the study on the prevalence of depression and anxiety in individuals with Type 1 diabetes, the Hospital Anxiety and Depression Scale was used. In a study conducted with a total of 502 individuals, it was found that anxiety was more common than depression in individuals with Type 1 diabetes, and depression and anxiety were more common in women than in men .
In the study investigating depressive symptoms in children and adolescents with Type 1 diabetes, the Children's Depression Inventory was administered to 145 children and adolescents with Type 1 Diabetes. As a result of the research, high rates of depression were found in 15% of children and adolescents. It has also been reported that depression increases in girls and with increasing age .
In the meta-analysis study , it was stated that only 51% of patients with Type 2 diabetes reached the hemoglobin A1c (HbA1c) target of <7%. Studies on HbA1c in adolescents with type 1 diabetes are limited in number; In the HbA1c study conducted by with 66 071 children and adolescents in 8 high-income countries, it was stated that the HbA1c value varied between 7.6% and 8.8% and that HbA1c increased significantly during the transition from childhood to adolescence Type 1 diabetes; In addition to being a metabolic, chronic and organic disease, it is also a disease that has a psychosocial dimension. Studies have shown that the rate of psychiatric disorders in adults with diabetes varies between 33% and 42% and is 2-3 times higher than the general prevalence rate in society, and another study has shown that in children aged 8-17, children and adolescents with insulin-dependent Type 1 diabetes, It is stated that they have more mental difficulties than their healthy peers.Adolescents with type 1 diabetes experience physical, emotional and social problems. It is suggested that the reason for this is that both the blood sugar level and its irregularities directly affect the brain and psychological functions, and the blood sugar level is affected by psychological and emotional changes. A child/adolescent with type 1 diabetes is obliged to carry out interventions such as measuring blood sugar more than once a day, adjusting the insulin dose and administering insulin for the management of the disease, and must cope with this situation. Due to all these reasons, in adolescents with Type 1 diabetes; Depression, anxiety disorder, decrease in quality of life, eating disorder, fear of hypoglycemia, difficulty in coping and adjustment disorder may develop. Positive results are achieved with the Mindfulness-Based Stress Reduction Program and yoga practice, which are mind and body-based interventions in the process of coping with the psychosocial and physiological problems experienced by adolescents with type 1 ..diabetes.
- Being tested
- Yoga, Mindfulness
- Keywords
- Mindfulness, Yoga, Type 1 Diabetes, Youth, Stress Level, Quality of Life, Glycemic Control
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
Applying yoga for one hour a week for eight weeks to an adolescent with type 1 diabetes
MindfulnessBehavioural
Applying mindfulness for one hour a week for eight weeks to an adolescent with type 1 diabetes
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | Applying yoga for one hour a week for eight weeks to with type 1 diabetes Receives: Behavioral: Yoga |
| Mindfulness | Active comparator | Applying mindfulness to youth with type 1 diabetes one hour a week for eight weeks Receives: Behavioral: Mindfulness |
| control | No intervention | the control group received the usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
10-item version of the Diabetes Stress Questionnaire for Youths with Type 1 Diabetes
use the scale with patients 12 and up and we administer it via online survey (Qualtrics). Scores vary from 0 (not at all) to 3 (very much), so the min score=0, and the max score=30. We use the clinical cut off of 12 (scores >=12 are flagged).
Measured: 8 weeks
pediatrics quality of life inventoryTM (PedsQL) diabetes module 3.0 for Turkish adolescents with type 1 diabetes scale
The 28-item multidimensional PedsQLTM 3.0 Diabetes Module included five subscales, which are diabetes symptoms (11 items), treatment barriers (4 items), treatment adherence (7 items), worry (3 items), and communication (3 items). The format
Measured: 8 weeks
Glycemic control form
it is an assessment tool developed to evaulate the hemoglobin A1C
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 posted12 Jan 2024
- Study start15 Mar 2023
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EMİNE SARIKAMIŞ KALE, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202950
- Sponsor's protocol ID
- 2023/70
- Status last verified
- Dec 2025
- First submitted
- 2 Jan 2024
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness and Yoga on Stress Level, Quality of Life and Glycemic Control in Youth With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06202950
- Acronym / sponsor ID
- 2023/70
- Keywords
- Mindfulness, Yoga, Type 1 Diabetes, Youth, Stress Level, Quality of Life, Glycemic Control
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 12 Jan 2024 (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 study will examine the effects of Mindfulness-Based Stress Reduction Program and yoga on stress level, quality of life and glycemic control in Youth with Type 1 diabetes.
Detailed description
Chronic disease; It is defined as a condition that causes permanent disability, is irreversible, occurs as a result of pathological changes, requires special training, long-term care, supervision and control for the rehabilitation of the patient, and limits daily functions. According to the World Health Organization (WHO) data on chronic diseases; Every year, 41 million people in the world die due to chronic diseases, and it is stated that these numbers correspond to 74% of the deaths in the world. Nowadays, chronic diseases are becoming an increasing health problem, especially for children and adolescents. According to WHO, the incidence of chronic diseases in adolescence is reported to be 15%. According to the report published by the American Academy of Pediatrics (APA), 10-20 million children and adolescents in the United States (USA) have some kind of chronic disease.Diabetes is one of the most common non-communicable chronic diseases globally. Diabetes Mellitus (DM) is a chronic metabolic disease that develops as a result of insufficiency, deficiency and/or absence of the insulin hormone secreted from beta cells in the pancreas, is characterized by hyperglycemia, and causes disorders in carbohydrate, fat and protein metabolism. It has a chronic course and is the most common metabolic disease in childhood. Although there are different types of diabetes, Type 1 diabetes is common in childhood. Type 1 diabetes cases constitute 10-15% of all diabetic patients, and this rate is increasing. Genetic, environmental and autoimmune factors play an important role in the development of Type 1 diabetes . The incidence of the disease, which is often seen between the ages of 7-15, increases between the ages of 4-6 and 10-14. According to the 10th Diabetes Atlas data published by the International Diabetes Federation in 2021; There are 536.6 million people with diabetes worldwide, and this number is expected to increase to 783.2 million in 2045. It is reported that the number of individuals with diabetes among children and adolescents between the ages of 0-19 worldwide is approximately 1.99 million, and 1.2 million of this number consists of children and adolescents with Type 1 diabetes. In our country, it is reported that the number of children and adolescents with Type 1 diabetes between the ages of 0-18 is approximately 17 thousand and the number of adolescents with diabetes between the ages of 10-18 is approximately 13 thousand.The fact that diabetes is a disease that is not easy to manage, combined with problems such as estrangement from parents in adolescence, increased sense of independence, physiological change and peer pressure, can cause many difficulties for the adolescent in fulfilling his developmental tasks.
In studies conducted with adolescents with type 1 diabetes; In the study to determine the quality of life of healthy children/adolescents with Type 1 diabetes aged 4-15, it was found that the quality of life of children and adolescents with Type 1 diabetes was lower than that of healthy children and adolescents.
In order to determine the time management skills of adolescents with Type 1 diabetes and the effect of these skills on metabolic control, another study with 69 adolescents with Type 1 diabetes between the ages of 13-19, using the Diabetes Adolescent Diagnosis Form, Diabetes Time Management Questionnaire (DBYA), Habits and Behaviors in Adaptation to Diabetes. In the research conducted using the and Information Survey (DUADBA), Metabolic Control and Daily Record Form; It has been stated that adolescents with good time management manage diabetes better and that managing diabetes well does not affect metabolic control.study applied the Psychological Symptom Screening Test (SCL-90-R) to 56 individuals with Type 1 diabetes between the ages of 7 and 21 in order to determine the psychological symptoms and findings of children and adolescents attending a diabetes camp. As a result of this research, "50.9% of the patients had somatization, 47.3% had anxiety, 43.9% had obsession, 33.3% had depression, 37.5% had psychosis, 48.2% had It was determined that there were multiple psychiatric findings, including anger in 100% of patients and phobia in 28.1%.In the study to examine the self-concept of children/adolescents with Type 1 diabetes and their ways of coping with stress; It has been stated that self-concept is higher in those with a short duration of diabetes or 11-15 years than in those with a diabetes duration of 6-10 years, and that coping with stress was found to be higher in adolescents aged 14-17 without Type 1 diabetes than in adolescents with diabetes .
In the research conducted with 349 adolescents with Type 1 diabetes and 409 healthy individuals between the ages of 6-18 from Kuwait, in order to examine the social and psychological conditions of children/adolescents; Depression and anxiety levels of children and adolescents with type 1 diabetes were found to be higher and their psychosocial relationships were worse.In a study to examine the symptoms of depression in adolescents with Type 1 diabetes, including 45 male and 72 female adolescents with Type 1 diabetes, depressive symptoms were found in 50% of the adolescents. It has also been reported that adolescents between the ages of 14 and 16 have more depressive symptoms than younger ones.
In the study which the coping skills with anxiety and glycemic control were investigated in adolescents with Type 1 diabetes, 145 individuals were studied and the Coping Inventory of Stressful Situations was applied. In this study, it was found that as the duration of the disease increases, anxiety decreases and the ability to cope with the disease increase.In the study on the prevalence of depression and anxiety in individuals with Type 1 diabetes, the Hospital Anxiety and Depression Scale was used. In a study conducted with a total of 502 individuals, it was found that anxiety was more common than depression in individuals with Type 1 diabetes, and depression and anxiety were more common in women than in men .
In the study investigating depressive symptoms in children and adolescents with Type 1 diabetes, the Children's Depression Inventory was administered to 145 children and adolescents with Type 1 Diabetes. As a result of the research, high rates of depression were found in 15% of children and adolescents. It has also been reported that depression increases in girls and with increasing age .
In the meta-analysis study , it was stated that only 51% of patients with Type 2 diabetes reached the hemoglobin A1c (HbA1c) target of <7%. Studies on HbA1c in adolescents with type 1 diabetes are limited in number; In the HbA1c study conducted by with 66 071 children and adolescents in 8 high-income countries, it was stated that the HbA1c value varied between 7.6% and 8.8% and that HbA1c increased significantly during the transition from childhood to adolescence Type 1 diabetes; In addition to being a metabolic, chronic and organic disease, it is also a disease that has a psychosocial dimension. Studies have shown that the rate of psychiatric disorders in adults with diabetes varies between 33% and 42% and is 2-3 times higher than the general prevalence rate in society, and another study has shown that in children aged 8-17, children and adolescents with insulin-dependent Type 1 diabetes, It is stated that they have more mental difficulties than their healthy peers.Adolescents with type 1 diabetes experience physical, emotional and social problems. It is suggested that the reason for this is that both the blood sugar level and its irregularities directly affect the brain and psychological functions, and the blood sugar level is affected by psychological and emotional changes. A child/adolescent with type 1 diabetes is obliged to carry out interventions such as measuring blood sugar more than once a day, adjusting the insulin dose and administering insulin for the management of the disease, and must cope with this situation. Due to all these reasons, in adolescents with Type 1 diabetes; Depression, anxiety disorder, decrease in quality of life, eating disorder, fear of hypoglycemia, difficulty in coping and adjustment disorder may develop. Positive results are achieved with the Mindfulness-Based Stress Reduction Program and yoga practice, which are mind and body-based interventions in the process of coping with the psychosocial and physiological problems experienced by adolescents with type 1 ..diabetes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Behavioral: YogaApplying yoga for one hour a week for eight weeks to with type 1 diabetes |
| Mindfulness | Active comparator | Behavioral: MindfulnessApplying mindfulness to youth with type 1 diabetes one hour a week for eight weeks |
| control | No intervention | –the control group received the usual care |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Youth with Type 1 diabetes between the ages of 13 and 18 with a diabetes age of at least 12 months
- Not having participated in a Mindfulness-Based Stress Reduction Program or doing yoga before,
- Speaking and understanding Turkish,
- Able to read and write,
- Having no other physiological or psychological diseases,
Key exclusion criteria (2 listed)
- Failed to complete the program
- Youth diagnosed with acute or chronic diseases in addition to diabetes during the study
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 |
|---|---|---|
| YogaApplying yoga for one hour a week for eight weeks to an adolescent with type 1 diabetes | Behavioural | Yoga |
| MindfulnessApplying mindfulness for one hour a week for eight weeks to an adolescent with type 1 diabetes | Behavioural | Mindfulness |
Primary outcome
10-item version of the Diabetes Stress Questionnaire for Youths with Type 1 Diabetes
Time frame: 8 weeks
use the scale with patients 12 and up and we administer it via online survey (Qualtrics). Scores vary from 0 (not at all) to 3 (very much), so the min score=0, and the max score=30. We use the clinical cut off of 12 (scores >=12 are flagged).
pediatrics quality of life inventoryTM (PedsQL) diabetes module 3.0 for Turkish adolescents with type 1 diabetes scale
Time frame: 8 weeks
The 28-item multidimensional PedsQLTM 3.0 Diabetes Module included five subscales, which are diabetes symptoms (11 items), treatment barriers (4 items), treatment adherence (7 items), worry (3 items), and communication (3 items). The format
Glycemic control form
Time frame: 12 weeks
it is an assessment tool developed to evaulate the hemoglobin A1C
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga and Mindfulness in people with Diabetes and Stress, run by Hasan Kalyoncu University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
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?
10-item version of the Diabetes Stress Questionnaire for Youths with Type 1 Diabetes (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.