Gestatiaonl Diabetes MellitusNCT07269405
Study to Prevent Dysglycemia in Women With GDM
A study testing Intervention and Conventional care in people with Gestatiaonl Diabetes Mellitus and GDM, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Women with a history of gestational diabetes mellitus (GDM) have a 7-fold increased risk of type 2 diabetes (T2D), with the risk at its highest during the 3-6 years postpartum. GDM thus represents one of the strongest known risk factors for T2D. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Gestatiaonl Diabetes Mellitus, GDM
- What is being tested?
- Intervention and Conventional care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteHong Kong
- Study dates
- 26 Sep 2025to Mar 2030
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with a history of gestational diabetes mellitus and one additional risk factor (obesity, family history of diabetes, impaired fasting glycemia and/or impaired glucose tolerance and/ and or risk understanding by yourself RUBY score of ≥ 8) at 6-12 weeks postpartum
- Singleton pregnancy
- Willingness, ability and commitment to comply with study procedures
- In the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude the patient from being a suitable study candidate.
- Normally residing in Hong Kong
- Able to communicate in Chinese
- Written informed consent to participate in the study provided by the patient
Who cannot join
- Known current diabetes
- Current or previous use of glucose-lowering or weight loss drugs at screening
- Concurrent participation in other weight loss or lifestyle intervention programmes
- Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study
- Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff
- Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device
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- Known uncontrolled thyrotoxicosis
- Current use of steroids
- Known current or recent alcohol or drug abuse
- Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection
- An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
Department of Medicine and Therapeutics, The Chinese University of Hong Kong (CUHK), Ward 3M, Diabetes and Endocrine Research Centre, 3/F Day Treatment Block and Children Wards (Old Block), Prince of Wales Hospital
Shatin
About this study
Official title: A Randomised Controlled Trial of a Multi-component Postpartum Intervention to Prevent Dysglycemia in Women With a History of Gestational Diabetes Mellitus (GDM)
Women with a history of gestational diabetes mellitus (GDM) have a 7-fold increased risk of type 2 diabetes (T2D), with the risk at its highest during the 3-6 years postpartum. GDM thus represents one of the strongest known risk factors for T2D.
Only 30-60% of women with GDM returned for postpartum visits, with the majority defaulting on postpartum glucose tolerance testing. Women with GDM also have an increased risk of hypertension, cardiovascular disease (CVD), non-alcoholic fatty liver disease, and other comorbidities. Through this study, participants will receive lifestyle advice that may help them prevent diabetes. The study will help determine whether a multicomponent intervention will prevent incident dysglycemia and improve offspring cardiometabolic health. This will inform healthcare professionals and policymakers if these interventions are helpful. The control group will receive basic dietary information leaflets and will have access to the e-care platform for the three-year period (8-166 weeks postnatal). They will receive routine lifestyle advice and counseling. The intervention groups will receive information on basic dietary information and have access to the e-platform. Participants will attend individualized/group dietary counseling sessions biweekly in the first 4 months during the intensive phase (V1-V7) and thereafter bimonthly (V8-10, 28-50 weeks postnatal) and biyearly between year 1 to year 3. This will include 16 sessions with a dietitian/nutritionist and 4 sessions with an exercise instructor. Participants will be given an individualized menu plan aiming at achieving a varied, balanced diet with an emphasis on fiber intake and moderate-carbohydrate, low-fat, low-glycemic index products in appropriate portions. The lifestyle intervention program will incorporate motivational interviewing and behavioral modification to enhance health knowledge on daily diet and physical activity. The lifestyle intervention aims to achieve targets on body weight, dietary intake, and physical activities.
Read the detailed description
The high-risk nature of women with GDM highlights this group as the "low-hanging fruit" who would substantially benefit from engagement in diabetes prevention programs. Lifestyle intervention has been shown to reduce the progression to T2D among women with GDM.
In a systematic review and meta-analysis including 8 lifestyle intervention trials implemented post-GDM, there was a homogenous 25% reduction (relative risk (RR): 0.75; 95% confidence interval (CI) 0.55-1.03) in incident diabetes, though not statistically significant. Of note, trials offering intervention soon after delivery (i.e., <6 months postpartum) were most effective. This contrasts with efforts during pregnancy to reduce GDM, which have failed to reduce GDM unless initiated very early. The long-term follow-up of mothers and offspring from the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study has highlighted the increased risk of adiposity, obesity, and diabetes in offspring, who are at increased risk of NCDs later in life. Hence, enrolling mothers with GDM in empowerment and prevention programs will not only reduce their risk of diabetes and CVD but may also benefit other family members, in particular the offspring.
In a previous pilot lifestyle intervention trial in mothers with GDM in the postpartum setting (NCT03669887), the investigators established the logistics of engaging mothers during the busy postpartum period, performing repeated OGTTs and clinical assessments, and co-designing with mothers a lifestyle intervention curriculum suitable for implementation during the postpartum period. The investigators demonstrated the benefit of the intervention in improving the health behaviors of GDM mothers at 1 year. The investigators were able to engage participants with GDM and noted their misconceptions about the long-term impact of GDM, their concerns about whether they can breastfeed, and lack of awareness of the risk of obesity in their offspring. The intervention arm had improved dietary quality as measured using the Dietary Quality Index-International (DQI-I) score, more favorable changes in BMI at 6 months postpartum, and a trend towards better glycemic status after 12 months.
Objectives:
Primary objective
- To evaluate the effect of a multicomponent postpartum intervention to prevent incident dysglycemia in women with a history of GDM.
Secondary objectives"
- To evaluate the effect of a multicomponent intervention on body weight and composition.
- To evaluate the effect of a multicomponent intervention on cardiometabolic health parameters including blood pressure, heart rate, vital signs, and lipid profiles.
- To evaluate the effect of a multicomponent intervention on continuous glucose monitoring metrics.
- To evaluate the effect of a multicomponent intervention on dietary intake.
- To evaluate the effect of a multicomponent intervention on physical activity.
- To evaluate the effect of a multicomponent intervention on breastfeeding and infant feeding practices.
- To evaluate the effect of a multicomponent intervention on offspring growth, weight, and adiposity.
Compared with conventional care.
Study design: Multi-center, prospective, parallel-group, open-label randomized controlled trial Study population: Women with a history of GDM Sample size: 800 subjects Intervention: Multicomponent intervention including e-care and wearables Comparator: Conventional care
Setting:
Women with a history of gestational diabetes will be identified from antenatal clinics. The study will be conducted at the Prince of Wales Hospital and the CUHK Medical Centre.
- Conditions
- Gestatiaonl Diabetes Mellitus, GDM
- Being tested
- Intervention, Conventional care
- Keywords
- Gestatiaonl diabetes mellitus, GDM, Postpartum, Lifestyle intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
The intervention groups will receive information on basic dietary information and have access to e-platform.
Participants will attend individualised/ group dietary counselling sessions biweekly in the first 4 months during the intensive phase and thereafter bimonthly and biyearly between year 1 to year 3.
This will include 16 sessions with a dietitian/nutritionist and 4 sessions with an exercise instructor. Participants will be given an individualized menu plan aiming at achieving a varied balanced diet with an emphasis on fibre intake and moderate-carbohydrate, low-fat, low-glycaemic index products in appropriate portions.
Conventional careOther
The control group will receive basic dietary information leaflets and will have access to the e-care platform for the three-year period. The control group will receive routine lifestyle advice.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent Lifestyle Intervention | Experimental | Multicomponent intervention include e-care and wearables Receives: Behavioral: Intervention |
| Conventional Care | Other | Conventional care Receives: Other: Conventional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion with deterioration in glycaemic status (ie. from NGT to pre-diabetes (IFG or IGT), or pre-diabetes to T2D, based on annual OGTT
Measured: 1 Year, 2 Year, 3 Year
Secondary outcomes (13)
Fasting glucose and post challenge glucose
Difference between intervention and control groups in fasting glucose and post challenge glucose
Measured: 1 Year, 2 Year, 3 Year
Body weight
Difference between intervention and control groups in body weight
Measured: End of intensive intervention period (Postnatal week 20-26) and 1 Year, 2 Year, 3 Year
BMI
Difference between intervention and control groups in BMI
Measured: End of intensive intervention period (Postnatal week 20-26) and 1 Year, 2 Year, 3 Year
Body composition
Difference between intervention and control groups in body composition
Measured: End of intensive intervention period (Postnatal week 20-26) and 1 Year, 2 Year, 3 Year
Systolic and diastolic blood pressure
Difference between intervention and control groups in systolic and diastolic blood pressure
Measured: End of intensive intervention period (Postnatal week 20-26) and 1 Year, 2 Year, 3 Year
Heart rate
Difference between intervention and control groups in heart rate
Measured: End of intensive intervention period (Postnatal week 20-26) and 1 Year, 2 Year, 3 Year
CGM metrics
Difference between intervention and control groups in CGM metrics, including times in range (TIR), above range, and below range
Measured: End of intensive intervention period (Postnatal week 20-26) and 1 Year, 2 Year, 3 Year
Physical activity levels (IPAQ)
Difference between intervention and control groups in physical activity levels assessed by IPAQ
Measured: End of intensive intervention period (Postnatal week 20-26) and 1 Year, 2 Year, 3 Year
Diet composition and quality (The FIGO Nutrition Checklist)
Difference between intervention and control groups in diet composition and quality assessed by The FIGO Nutrition Checklist
Measured: End of intensive intervention period (Postnatal week 20-26) and 1 Year, 2 Year, 3 Year
Lipid profiles
Difference between intervention and control groups in lipid profiles
Measured: 1 Year, 2 Year, 3 Year
Proportion breastfed
Difference between intervention and control groups in proportion of breastfed
Measured: End of intensive intervention period (Postnatal week 20-26) and 1 Year, 2 Year, 3 Year
Offspring weight
Difference between intervention and control groups in offspring weight
Measured: Postnatal week 160-166
Offspring adiposity (skinfold thickness)
Difference between intervention and control groups in offspring adiposity (skinfold thickness)
Measured: Postnatal week 160-166
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start26 Sep 2025
- Primary completionMar 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestatiaonl Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-component lifestyle intervention
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Ronald C.W. Ma, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269405
- Sponsor's protocol ID
- 2025.127
- Status last verified
- Nov 2025
- First submitted
- 2 Oct 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: to further seek approval among project team
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of a Multi-component Postpartum Intervention to Prevent Dysglycemia in Women With a History of Gestational Diabetes Mellitus (GDM)
- ClinicalTrials.gov ID
- NCT07269405
- Acronym / sponsor ID
- 2025.127
- Conditions
- Gestatiaonl Diabetes Mellitus, GDM
- Keywords
- Gestatiaonl diabetes mellitus, GDM, Postpartum, Lifestyle intervention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 26 Sep 2025 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 8 Dec 2025 (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.
Women with a history of gestational diabetes mellitus (GDM) have a 7-fold increased risk of type 2 diabetes (T2D), with the risk at its highest during the 3-6 years postpartum. GDM thus represents one of the strongest known risk factors for T2D.
Only 30-60% of women with GDM returned for postpartum visits, with the majority defaulting on postpartum glucose tolerance testing. Women with GDM also have an increased risk of hypertension, cardiovascular disease (CVD), non-alcoholic fatty liver disease, and other comorbidities. Through this study, participants will receive lifestyle advice that may help them prevent diabetes. The study will help determine whether a multicomponent intervention will prevent incident dysglycemia and improve offspring cardiometabolic health. This will inform healthcare professionals and policymakers if these interventions are helpful. The control group will receive basic dietary information leaflets and will have access to the e-care platform for the three-year period (8-166 weeks postnatal). They will receive routine lifestyle advice and counseling. The intervention groups will receive information on basic dietary information and have access to the e-platform. Participants will attend individualized/group dietary counseling sessions biweekly in the first 4 months during the intensive phase (V1-V7) and thereafter bimonthly (V8-10, 28-50 weeks postnatal) and biyearly between year 1 to year 3. This will include 16 sessions with a dietitian/nutritionist and 4 sessions with an exercise instructor. Participants will be given an individualized menu plan aiming at achieving a varied, balanced diet with an emphasis on fiber intake and moderate-carbohydrate, low-fat, low-glycemic index products in appropriate portions. The lifestyle intervention program will incorporate motivational interviewing and behavioral modification to enhance health knowledge on daily diet and physical activity. The lifestyle intervention aims to achieve targets on body weight, dietary intake, and physical activities.
Detailed description
The high-risk nature of women with GDM highlights this group as the "low-hanging fruit" who would substantially benefit from engagement in diabetes prevention programs. Lifestyle intervention has been shown to reduce the progression to T2D among women with GDM.
In a systematic review and meta-analysis including 8 lifestyle intervention trials implemented post-GDM, there was a homogenous 25% reduction (relative risk (RR): 0.75; 95% confidence interval (CI) 0.55-1.03) in incident diabetes, though not statistically significant. Of note, trials offering intervention soon after delivery (i.e., <6 months postpartum) were most effective. This contrasts with efforts during pregnancy to reduce GDM, which have failed to reduce GDM unless initiated very early. The long-term follow-up of mothers and offspring from the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study has highlighted the increased risk of adiposity, obesity, and diabetes in offspring, who are at increased risk of NCDs later in life. Hence, enrolling mothers with GDM in empowerment and prevention programs will not only reduce their risk of diabetes and CVD but may also benefit other family members, in particular the offspring.
In a previous pilot lifestyle intervention trial in mothers with GDM in the postpartum setting (NCT03669887), the investigators established the logistics of engaging mothers during the busy postpartum period, performing repeated OGTTs and clinical assessments, and co-designing with mothers a lifestyle intervention curriculum suitable for implementation during the postpartum period. The investigators demonstrated the benefit of the intervention in improving the health behaviors of GDM mothers at 1 year. The investigators were able to engage participants with GDM and noted their misconceptions about the long-term impact of GDM, their concerns about whether they can breastfeed, and lack of awareness of the risk of obesity in their offspring. The intervention arm had improved dietary quality as measured using the Dietary Quality Index-International (DQI-I) score, more favorable changes in BMI at 6 months postpartum, and a trend towards better glycemic status after 12 months.
Objectives:
Primary objective
- To evaluate the effect of a multicomponent postpartum intervention to prevent incident dysglycemia in women with a history of GDM.
Secondary objectives"
- To evaluate the effect of a multicomponent intervention on body weight and composition.
- To evaluate the effect of a multicomponent intervention on cardiometabolic health parameters including blood pressure, heart rate, vital signs, and lipid profiles.
- To evaluate the effect of a multicomponent intervention on continuous glucose monitoring metrics.
- To evaluate the effect of a multicomponent intervention on dietary intake.
- To evaluate the effect of a multicomponent intervention on physical activity.
- To evaluate the effect of a multicomponent intervention on breastfeeding and infant feeding practices.
- To evaluate the effect of a multicomponent intervention on offspring growth, weight, and adiposity.
Compared with conventional care.
Study design: Multi-center, prospective, parallel-group, open-label randomized controlled trial Study population: Women with a history of GDM Sample size: 800 subjects Intervention: Multicomponent intervention including e-care and wearables Comparator: Conventional care
Setting:
Women with a history of gestational diabetes will be identified from antenatal clinics. The study will be conducted at the Prince of Wales Hospital and the CUHK Medical Centre.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multi-component lifestyle intervention
| Arm | Type | Receives |
|---|---|---|
| Multicomponent Lifestyle Intervention | Experimental | Behavioral: InterventionMulticomponent intervention include e-care and wearables |
| Conventional Care | Other | Other: Conventional careConventional care |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women with a history of gestational diabetes mellitus and one additional risk factor (obesity, family history of diabetes, impaired fasting glycemia and/or impaired glucose tolerance and/ and or risk understanding by yourself RUBY score of ≥ 8) at 6-12 weeks postpartum
- Singleton pregnancy
- Willingness, ability and commitment to comply with study procedures
- In the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude the patient from being a suitable study candidate.
- Normally residing in Hong Kong
Key exclusion criteria (11 listed)
- Known current diabetes
- Current or previous use of glucose-lowering or weight loss drugs at screening
- Concurrent participation in other weight loss or lifestyle intervention programmes
- Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study
- Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff
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 |
|---|---|---|
| InterventionThe intervention groups will receive information on basic dietary information and have access to e-platform. Participants will attend individualised/ group dietary counselling sessions biweekly in the first 4 months during the intensive phase and thereafter bimonthly and biyearly between year 1 to year 3. This will include 16 sessions with a dietitian/nutritionist and 4 sessions with an exercise instructor. Participants will be given an individualized menu plan aiming at achieving a varied balanced diet with an emphasis on fibre intake and moderate-carbohydrate, low-fat, low-glycaemic index products in appropriate portions. | Behavioural | Multicomponent Lifestyle Intervention |
| Conventional careThe control group will receive basic dietary information leaflets and will have access to the e-care platform for the three-year period. The control group will receive routine lifestyle advice. | Other | Conventional Care |
Primary outcome
Proportion with deterioration in glycaemic status (ie. from NGT to pre-diabetes (IFG or IGT), or pre-diabetes to T2D, based on annual OGTT
Time frame: 1 Year, 2 Year, 3 Year
13 secondary outcomes
Fasting glucose and post challenge glucose
Time frame: 1 Year, 2 Year, 3 Year
Body weight
Time frame: End of intensive intervention period (Postnatal week 20-26) and 1 Year, 2 Year, 3 Year
BMI
Time frame: End of intensive intervention period (Postnatal week 20-26) and 1 Year, 2 Year, 3 Year
Body composition
Time frame: End of intensive intervention period (Postnatal week 20-26) and 1 Year, 2 Year, 3 Year
Systolic and diastolic blood pressure
Time frame: End of intensive intervention period (Postnatal week 20-26) and 1 Year, 2 Year, 3 Year
Heart rate
Time frame: End of intensive intervention period (Postnatal week 20-26) and 1 Year, 2 Year, 3 Year
CGM metrics
Time frame: End of intensive intervention period (Postnatal week 20-26) and 1 Year, 2 Year, 3 Year
Physical activity levels (IPAQ)
Time frame: End of intensive intervention period (Postnatal week 20-26) and 1 Year, 2 Year, 3 Year
Diet composition and quality (The FIGO Nutrition Checklist)
Time frame: End of intensive intervention period (Postnatal week 20-26) and 1 Year, 2 Year, 3 Year
Lipid profiles
Time frame: 1 Year, 2 Year, 3 Year
Proportion breastfed
Time frame: End of intensive intervention period (Postnatal week 20-26) and 1 Year, 2 Year, 3 Year
Offspring weight
Time frame: Postnatal week 160-166
Offspring adiposity (skinfold thickness)
Time frame: Postnatal week 160-166
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 23 Dec 2025.
- Individual participant dataSharing planned: Undecided. to further seek approval among project team
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention and Conventional care in people with Gestatiaonl Diabetes Mellitus and GDM, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 7 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: enrolling by invitation, as of the sponsor's last update on 23 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 1 site in Hong Kong. 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?
Proportion with deterioration in glycaemic status (ie. from NGT to pre-diabetes (IFG or IGT), or pre-diabetes to T2D, based on annual OGTT (time frame: 1 Year, 2 Year, 3 Year). 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 23 Dec 2025.