AgingLIMB-QNCT03329963
Lifestyle Intervention to Improve Bone Quality
A study testing Healthy Lifestyle Intervention and Lifestyle Intervention in people with Aging and Obesity, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Obese older adults will be randomized to participate in either healthy lifestyle intervention or behavioral diet and exercise intervention for one year. This study aims to determine the effects of Lifestyle intervention on bone microarchitecture, bone strength, bone material properties, and the mechanism behind it. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- What is being tested?
- Healthy Lifestyle Intervention and Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2017to 16 Jan 2023
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 - 85 years • BMI 30 kg/m2 or more• Stable body weight (±2 kg) during the past 6 months • Sedentary (regular exercise <1 h/wk. or <2 x/wk. for the last 6 months) • Willing to provide informed consent
Who cannot join
- Failure to provide informed consent.
- Any major chronic diseases, or any condition that would interfere with exercise or dietary restriction, in which exercise or dietary restrictions are contraindicated, or that would interfere with interpretation of results
- Cardiopulmonary disease (e.g. recent myocardial infarction, unstable angina, stroke) or unstable disease (e.g., New York Heart Class III or IV congestive heart failure, severe pulmonary disease requiring steroid pills or the use of supplemental oxygen ) that would contraindicate exercise or dietary restriction
- Severe orthopedic (e.g. awaiting joint replacement) and/or neuromuscular (e.g. multiple sclerosis, amyotrophic lateral sclerosis, active rheumatoid arthritis) disease or impairments that would contraindicate participation in exercise
- Other significant co-morbid disease that would impair ability to participate in the exercise-based intervention (e.g. renal failure on hemodialysis, severe psychiatric disorder [e.g. bipolar, schizophrenia], excess alcohol use [more than14 drinks per week])
- Severe visual or hearing impairments that would interfere with following directions
Show all 14Show fewer
- Significant cognitive impairment, defined as a known diagnosis of dementia or positive screening test for dementia using the Mini-Mental State Exam score less than 24)
- Uncontrolled hypertension (BP>160/90 mm Hg)
- History of malignancy during the past 5 years (except non-melanoma skin cancers)
- Current use of bone acting drugs (e.g. use of estrogen, or androgen containing compound, raloxifene, calcitonin, parathyroid hormone during the past year or bisphosphonates during the last two years)
- Osteoporosis (T-score -2.5 and below on hip or spine scan) or history of fragility fractures - Diabetes mellitus requiring insulin for treatment or with a fasting blood glucose of >140 mg/dl, and/or HbA1c >8.5% (Those excluded from the study because of fasting blood glucose of >140 mg/dl or HbA1c>8.5% will be referred to their primary care provider for follow-up and appropriate treatment).
- Terminal illness with life expectancy less than 12 months, as determined by a physician
- Use of any drugs or natural products designed to induce weight loss within past three months.
- Positive exercise stress test for ischemia
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E Debakey VA Medical Center
Houston, Texas, 77030
About this study
Official title: Does Lifestyle Intervention Improve Bone Quality in Obese Older Adults?
Obese older adults will be randomized to participate in either healthy lifestyle intervention or behavioral diet and exercise intervention for one year. This study aims to determine the effects of Lifestyle intervention on bone microarchitecture, bone strength, bone material properties, and the mechanism behind it.
Read the detailed description
Previous studies had suggested that lifestyle therapy (diet plus exercise) resulting in weight loss in elderly population improves physical function, cardio metabolic risk factors, and cognition/quality of life, but a major complication is loss of BMD. The addition of exercise to diet-induced weight loss attenuated but did not eliminate weight-loss-induced reduction of BMD. Moreover, while long-term maintenance of weight loss and physical function was feasible, sustained lifestyle change led to continued loss of hip BMD, which might predict hip fractures. Although similar BMD loss with weight loss has been observed in younger populations, BMD loss in older adults might be of particular concern because of aggravation of age-related bone loss. Moreover, the belief that obesity protects against fractures has now been challenged by studies demonstrating that obesity is associated with poor bone quality and ankle and leg fractures.Because of previous lack of options to assess bone quality in vivo, there has been little or no scientific study of the possibility that lifestyle therapy in obese older adults improves bone quality. This study represents an unprecedented opportunity to prove the hypothesis that lifestyle therapy intervention improves bone quality and thus, may confer a protective rather than adverse effect on bone health. This will be the first randomized controlled trial (RCT) to comprehensively assess bone quality using novel techniques in response to lifestyle therapy in obese older adults, with major ramifications with regards to defining optimal treatment strategies for this increasingly high-risk older population.
- Being tested
- Healthy Lifestyle Intervention, Lifestyle Intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Lifestyle InterventionBehavioural
Participants in the this group will receive group educational sessions that focus on diet, exercise, and social support once a month throughout the study. The sessions will provide an opportunity for participants to discuss issues related to living with obesity and aging.Participants will also attend regular scheduled clinic visits for assessment of outcomes.
Lifestyle InterventionBehavioural
The lifestyle modification will be achieved by group behavior therapy sessions designed to have older adults acquire positive weight-control skills/attitudes, and practice weight-maintenance skills.Participants will attend weekly group sessions (10-15 persons), which will last ~75-90 minutes. Visit frequency will be decreased to every 2 wks. from 6 to 12 mos. to prevent "treatment fatigue". A balanced diet will be prescribed to provide a deficit of 500-750 kcal/day from daily energy requirement.
The exercise sessions are of ~90 min duration (~15 min warm-up of flexibility exercise, followed by ~30 min of aerobic exercise, and after a brief rest period, ~30 min of resistance training, and finally ~15 min balance exercise) conducted three times weekly supervised at our exercise facility for one year. Aerobic exercises consist of treadmill, stationary cycling, and stair climbing.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle intervention Group | Experimental | Behavioral therapy for weight loss and Exercise Training Receives: Behavioral: Lifestyle Intervention |
| Healthy lifestyle intervention Group | Active comparator | Group education sessions that focus on diet exercise and social support. Receives: Behavioral: Healthy Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cortical thickness
Assessed by using high-resolution peripheral computed tomography (HR-pQCT)
Measured: Change from baseline at 12 months
Change in femoral bone strength
Assessed by using finite element analyses (FEA) of quantitative computed tomography (QCT)
Measured: Change from baseline at 12 months
Secondary outcomes (41)
Change in bone material strength
Assessed by using microindentation testing
Measured: Change from baseline at 12 months
Change in lower extremity strength
Assessed by using a Biodex dynamometer
Measured: Change from baseline at 12 months
Change in physical performance test
assessed by using the objective physical performance test
Measured: Change from baseline at 12 months
Change in gait speed
as measured by completing the time to walk a certain distance
Measured: Change from baseline at 12 months
Change in handgrip strength
Measured by hydraulic hand dynamometer
Measured: Change from baseline at 12 months
Change in trabecular thickness
Assessed by using HR-pQCT
Measured: Change from baseline at 12 months
Change in areal bone mineral density (BMD)
Assessed by using dual-energy x-ray absorptiometry
Measured: Change from baseline at 12 months
Change in trabecular number
Assessed by using HR-pQCT
Measured: Change from baseline at 12 month
Change in total volumetric BMD
Assessed by using HR-pQCT
Measured: Change from baseline at 12 months
Change in cortical volumetric BMD
Assessed by using HR-pQCT
Measured: Change from baseline at 12 months
Change in trabecular volumetric BMD
Assessed by using HR-pQCT
Measured: Change from baseline at 12 months
Change in stiffness
Assessed by using HR-pQCT
Measured: Change from baseline at 12 months
Change in trabecular separation
Assessed by using HR-pQCT
Measured: Change from baseline at 12 months
Change in micro-finite element analyses strength
Assessed by using HR-pQCT
Measured: Change from baseline at 12 months
Change in cortical porosity
Assessed by using HR-pQCT
Measured: Change from baseline at 12 months
Change in general quality of life
Assessed by using the Short Form-36 questionnaire
Measured: Change from baseline at 12 months
Change in obesity specific quality of life
Assessed by using the Impact of weight on quality of life short form (IWQOL-Lite) questionnaire
Measured: Change from baseline at 12 months
Change in mood
Assessed by using a mood scale questionnaire
Measured: Change from baseline at 12 months
Change in composite cognitive z-score
Using cognitive instrument testing
Measured: Change from baseline at 12 months
Change in cardio metabolic risk factors
Assessed by measuring metabolic syndrome components
Measured: Change from baseline at 12 months
Change in word list fluency
Assessed by using cognitive instrument testing
Measured: Change from baseline at 12 months
Change in Ray Auditory verbal learning test
Assessed by using cognitive instrument testing
Measured: Change from baseline at 12 months
Change in blood pressure
Assessed by usingSphygmomanometer
Measured: Change from baseline at 12 months
Change in biochemical marker for bone turnover and bone metabolism
Assessed by using enzyme linked immunosorbent assay and radioimmunoassay
Measured: Change from baseline at 12 months
Change in central volumetric BMD
Assessed by using CT scan at the spine and hip
Measured: Change from baseline at 12 months
Change in waist circumference
Assessed by using tape measurement
Measured: Change from baseline at 12 months
Change in lean mass
Assessed by using dual-energy x-ray absorptiometry
Measured: Change from baseline at 12 months
Change in fat mass
Assessed by using dual-energy x-ray absorptiometry
Measured: Change from baseline at 12 months
Change in visceral fat
Assessed by using dual-energy x-ray absorptiometry
Measured: Change from baseline at 12 months
Change in physical activity using accelerometer
Assessed by using an accelerometer
Measured: Change from baseline at 12 months
Change in body weight
Assessed by using weighing scale
Measured: Change from baseline at 12 months
Change in sclerostin
Assessed by using enzyme linked immunoassay
Measured: Change from baseline at 12 months
Change in wnt signaling pathways
Assessed by measurements of circulating levels of Wnt 5a and Sfrp5
Measured: Change from baseline at 12 months
Change in total body mass
Assessed byusing dual energy x-ray absorptiometry
Measured: Change from baseline at 12 months
Change in hormones
Assessed by usingenzyme link immunoassay
Measured: Change from baseline at 12 months
Change in thigh mass
Assessed by using CT scan
Measured: Change from baseline at 12 months
Change in circulating cytokines
Assessed by using enzyme linked immunoassay
Measured: Change from baseline at 12 months
Change in adipocytokines
Assessed by using enzyme linked immunoassay
Measured: Change from baseline at 12 months
Change in total volumetric BMD
Assessed by using QCT Pro software
Measured: Change from baseline at 12 months
Change in cortical trabecular BMD
Assessed by using QCT Pro software
Measured: Change from baseline at 12 months
Change in aerobic capacity
Assessed by using indirect calorimetry during graded treadmill test
Measured: Change from baseline at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start9 Nov 2017
- Primary completion16 Jan 2023
- Study completion16 Jan 2023
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 AgingStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Michael E. DeBakey VA Medical Center, Biomedical Research Institute of New Mexico
- Responsible party
- Principal investigator, Dennis T. Villareal, Baylor College of Medicine
- Investigators
- Dennis T Villareal, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329963
- Sponsor's protocol ID
- H-40373
- Other IDs
- R01DK109950
- Acronym
- LIMB-Q
- Status last verified
- May 2025
- First submitted
- 23 Oct 2017
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gregori G, Mediwala S, Liebschner M, Kim D, Bryant MS, Klonis N, Armamento-Villareal R, Qualls C, Villareal DT. Bone quality response to lifestyle intervention in older adults with obesity (LIMB-Q trial): a randomised controlled trial. Lancet Healthy Longev. 2025 Sep;6(9):100761. doi: 10.1016/j.lanhl.2025.100761. Epub 2025 Sep 18.
PubMed 40976254
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Lifestyle Intervention Improve Bone Quality in Obese Older Adults?
- ClinicalTrials.gov ID
- NCT03329963
- Acronym / sponsor ID
- LIMB-Q / H-40373
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Michael E. DeBakey VA Medical Center, Biomedical Research Institute of New Mexico
- Study start
- 9 Nov 2017 (actual)
- Primary completion
- 16 Jan 2023 (actual)
- Study completion
- 16 Jan 2023 (actual)
- First posted
- 6 Nov 2017 (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.
Obese older adults will be randomized to participate in either healthy lifestyle intervention or behavioral diet and exercise intervention for one year. This study aims to determine the effects of Lifestyle intervention on bone microarchitecture, bone strength, bone material properties, and the mechanism behind it.
Detailed description
Previous studies had suggested that lifestyle therapy (diet plus exercise) resulting in weight loss in elderly population improves physical function, cardio metabolic risk factors, and cognition/quality of life, but a major complication is loss of BMD. The addition of exercise to diet-induced weight loss attenuated but did not eliminate weight-loss-induced reduction of BMD. Moreover, while long-term maintenance of weight loss and physical function was feasible, sustained lifestyle change led to continued loss of hip BMD, which might predict hip fractures. Although similar BMD loss with weight loss has been observed in younger populations, BMD loss in older adults might be of particular concern because of aggravation of age-related bone loss. Moreover, the belief that obesity protects against fractures has now been challenged by studies demonstrating that obesity is associated with poor bone quality and ankle and leg fractures.Because of previous lack of options to assess bone quality in vivo, there has been little or no scientific study of the possibility that lifestyle therapy in obese older adults improves bone quality. This study represents an unprecedented opportunity to prove the hypothesis that lifestyle therapy intervention improves bone quality and thus, may confer a protective rather than adverse effect on bone health. This will be the first randomized controlled trial (RCT) to comprehensively assess bone quality using novel techniques in response to lifestyle therapy in obese older adults, with major ramifications with regards to defining optimal treatment strategies for this increasingly high-risk older population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention Group | Experimental | Behavioral: Lifestyle InterventionBehavioral therapy for weight loss and Exercise Training |
| Healthy lifestyle intervention Group | Active comparator | Behavioral: Healthy Lifestyle InterventionGroup education sessions that focus on diet exercise and social support. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Age 65 - 85 years • BMI 30 kg/m2 or more• Stable body weight (±2 kg) during the past 6 months • Sedentary (regular exercise <1 h/wk. or <2 x/wk. for the last 6 months) • Willing to provide informed consent
Key exclusion criteria (14 listed)
- Failure to provide informed consent.
- Any major chronic diseases, or any condition that would interfere with exercise or dietary restriction, in which exercise or dietary restrictions are contraindicated, or that would interfere with interpretation of results
- Cardiopulmonary disease (e.g. recent myocardial infarction, unstable angina, stroke) or unstable disease (e.g., New York Heart Class III or IV congestive heart failure, severe pulmonary disease requiring steroid pills or the use of supplemental oxygen ) that would contraindicate exercise or dietary restriction
- Severe orthopedic (e.g. awaiting joint replacement) and/or neuromuscular (e.g. multiple sclerosis, amyotrophic lateral sclerosis, active rheumatoid arthritis) disease or impairments that would contraindicate participation in exercise
- Other significant co-morbid disease that would impair ability to participate in the exercise-based intervention (e.g. renal failure on hemodialysis, severe psychiatric disorder [e.g. bipolar, schizophrenia], excess alcohol use [more than14 drinks per week])
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 |
|---|---|---|
| Healthy Lifestyle InterventionParticipants in the this group will receive group educational sessions that focus on diet, exercise, and social support once a month throughout the study. The sessions will provide an opportunity for participants to discuss issues related to living with obesity and aging.Participants will also attend regular scheduled clinic visits for assessment of outcomes. | Behavioural | Healthy lifestyle intervention Group |
| Lifestyle InterventionThe lifestyle modification will be achieved by group behavior therapy sessions designed to have older adults acquire positive weight-control skills/attitudes, and practice weight-maintenance skills.Participants will attend weekly group sessions (10-15 persons), which will last ~75-90 minutes. Visit frequency will be decreased to every 2 wks. from 6 to 12 mos. to prevent "treatment fatigue". A balanced diet will be prescribed to provide a deficit of 500-750 kcal/day from daily energy requirement. The exercise sessions are of ~90 min duration (~15 min warm-up of flexibility exercise, followed by ~30 min of aerobic exercise, and after a brief rest period, ~30 min of resistance training, and finally ~15 min balance exercise) conducted three times weekly supervised at our exercise facility for one year. Aerobic exercises consist of treadmill, stationary cycling, and stair climbing. | Behavioural | Lifestyle intervention Group |
Primary outcome
Change in cortical thickness
Time frame: Change from baseline at 12 months
Assessed by using high-resolution peripheral computed tomography (HR-pQCT)
Change in femoral bone strength
Time frame: Change from baseline at 12 months
Assessed by using finite element analyses (FEA) of quantitative computed tomography (QCT)
41 secondary outcomes
Change in bone material strength
Time frame: Change from baseline at 12 months
Change in lower extremity strength
Time frame: Change from baseline at 12 months
Change in physical performance test
Time frame: Change from baseline at 12 months
Change in gait speed
Time frame: Change from baseline at 12 months
Change in handgrip strength
Time frame: Change from baseline at 12 months
Change in trabecular thickness
Time frame: Change from baseline at 12 months
Change in areal bone mineral density (BMD)
Time frame: Change from baseline at 12 months
Change in trabecular number
Time frame: Change from baseline at 12 month
Change in total volumetric BMD
Time frame: Change from baseline at 12 months
Change in cortical volumetric BMD
Time frame: Change from baseline at 12 months
Change in trabecular volumetric BMD
Time frame: Change from baseline at 12 months
Change in stiffness
Time frame: Change from baseline at 12 months
Change in trabecular separation
Time frame: Change from baseline at 12 months
Change in micro-finite element analyses strength
Time frame: Change from baseline at 12 months
Change in cortical porosity
Time frame: Change from baseline at 12 months
Change in general quality of life
Time frame: Change from baseline at 12 months
Change in obesity specific quality of life
Time frame: Change from baseline at 12 months
Change in mood
Time frame: Change from baseline at 12 months
Change in composite cognitive z-score
Time frame: Change from baseline at 12 months
Change in cardio metabolic risk factors
Time frame: Change from baseline at 12 months
Change in word list fluency
Time frame: Change from baseline at 12 months
Change in Ray Auditory verbal learning test
Time frame: Change from baseline at 12 months
Change in blood pressure
Time frame: Change from baseline at 12 months
Change in biochemical marker for bone turnover and bone metabolism
Time frame: Change from baseline at 12 months
Change in central volumetric BMD
Time frame: Change from baseline at 12 months
Change in waist circumference
Time frame: Change from baseline at 12 months
Change in lean mass
Time frame: Change from baseline at 12 months
Change in fat mass
Time frame: Change from baseline at 12 months
Change in visceral fat
Time frame: Change from baseline at 12 months
Change in physical activity using accelerometer
Time frame: Change from baseline at 12 months
Change in body weight
Time frame: Change from baseline at 12 months
Change in sclerostin
Time frame: Change from baseline at 12 months
Change in wnt signaling pathways
Time frame: Change from baseline at 12 months
Change in total body mass
Time frame: Change from baseline at 12 months
Change in hormones
Time frame: Change from baseline at 12 months
Change in thigh mass
Time frame: Change from baseline at 12 months
Change in circulating cytokines
Time frame: Change from baseline at 12 months
Change in adipocytokines
Time frame: Change from baseline at 12 months
Change in total volumetric BMD
Time frame: Change from baseline at 12 months
Change in cortical trabecular BMD
Time frame: Change from baseline at 12 months
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 6 Jun 2025.
- Derived from this study: PubMed 40976254Gregori G, Mediwala S, Liebschner M, Kim D, Bryant MS, Klonis N, Armamento-Villareal R, Qualls C, Villareal DT. Bone quality response to lifestyle intervention in older adults with obesity (LIMB-Q trial): a randomised controlled trial. Lancet Healthy Longev. 2025 Sep;6(9):100761. doi: 10.1016/j.lanhl.2025.100761. Epub 2025 Sep 18.
- Individual participant dataSharing planned: No
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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.
Dennis T Villareal, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Lifestyle Intervention and Lifestyle Intervention in people with Aging and Obesity, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 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 6 Jun 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 United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
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?
Change in cortical thickness (time frame: Change from baseline at 12 months). 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 NCT03329963, 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 6 Jun 2025.