Health BehaviorNCT02998892
Effects of Microbouts of Activity on Metabolic Health
A study testing Traditional Exercise Training and Daily Microbursts of Activity in people with Health Behavior, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Population studies suggest that time spent in sedentary behaviors is associated with all-cause mortality including obesity, diabetes, and cardiovascular diseases, independent of time spent in exercise. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Traditional Exercise Training and Daily Microbursts of Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2017to 8 Oct 2021
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overweight but weight stable (+/- 3kg over previous 6 months) sedentary male and female adults (n=30) will be recruited.
- Ages between 18-45 years old
- BMI of 25-35 kg/m2
- Sedentary ( self report < 150min/wk of moderate-to-vigorous activity or less than 6,500 steps per day as measured for 5 days in free-living conditions with a pedometer).
- The use of birth pill control will be accepted
Who cannot join
- Any history of renal (present or past kidney failure, kidney transplant, dialysis or kidney cysts),
- Uncontrolled hypertension
- Cardiovascular (present or past atherosclerosis, heart attack, ischemic stroke, heart failure)
- Hepatic diseases (past or present hepatitis B or C, fibrosis, cirrhosis, NAFLD/NASH)
- Type 1 or 2 diabetes
- Cancer
Show all 14Show fewer
- Smoking
- Consumption of drugs (marijuana included)
- Consumption of alcohol (>40g/d)
- HIV positivity
- Psychiatric disorders
- Any medications known to interfere with lipid or energy metabolism
- Known physical activity contraindications
- Major illness/physical problems (acute or chronic) that may limit their ability to perform the walking activities
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Population studies suggest that time spent in sedentary behaviors is associated with all-cause mortality including obesity, diabetes, and cardiovascular diseases, independent of time spent in exercise. Frequent interruptions to sedentary time are however beneficially associated with metabolic health outcomes, even in individuals who exercise regularly. The goal is to use integrative approach to understand the biological mechanisms that underlie these associations in a longitudinal intervention study in overweight sedentary adults. The investigators believe that the proposed study will provide an initial evidence base for the health benefits of breaking up prolonged sitting with short bursts of activity. This innovative strategy may be more effective at combating the adverse effects of sedentary behaviors than more traditional approaches.
Read the detailed description
To compare the effects of 6-weeks of microbursts of moderate-intensity activity to a calorically equivalent single bout of 45 minutes of moderate-intensity exercise training, both performed 5 days per week for a total of 45 minutes, in free-living sedentary overweight adults on:
Aim 1: plasma inflammatory and cardiometabolic health biomarkers in association with total energy expenditure and time spent in sedentary behaviors.
H1: Microbursts of activity will result in higher daily energy expenditure and lower time spent sedentary, as respectively measured with doubly labeled water and accelerometry, than traditional exercise training. This will be associated with healthier inflammatory Interleukin 1 alpha (IL1a), Interleukin 6 (IL6), Interleukin 10 (IL10), Tumour Necrosis Factor alpha (TNFa) and cardiometabolic (triglycerides, cholesterol, C-Reactive Protein (CRP), High-density lipoprotein (HDL), and Low-density lipoprotein (LDL) profiles compared to those obtained with traditional exercise training program.
Aim 2: 24-hr total fat and carbohydrate oxidation, exogenous carbohydrate oxidation, dietary fat trafficking between oxidation and incorporation into muscle lipid fractions, and mitochondrial function.
H2: Both one single continuous bout and microbouts of activity will increase 24-hr total (whole-room calorimetry) and dietary (D31-palmitate) fat oxidation due to greater mitochondrial lipid oxidation (high resolution respirometry) and lower incorporation of dietary fatty acid into muscle lipid fractions (D31-palmitate), as compared to baseline sedentary control condition. Microbouts of activity will further result in greater increases in 24-hr total (whole-room calorimetry) and exogenous (U-13C6 glucose) carbohydrate oxidation and in mitochondrial carbohydrate-linked oxidation, than traditional isocaloric exercise training.
Aim 3: Whole-body insulin sensitivity and daily glucose mean and variability. H3: Both one single continuous bout and microbouts of activity will improve whole-body insulin sensitivity Intravenous Glucose Tolerance Test (IVGTT) compared to the baseline sedentary condition, but the improvement will likely be higher with the microbouts of activity. However, only the microbouts of activity will improve postprandial glycemia and the daily oscillations in glucose level as measured by CGM.
Exploratory aim: Self-perceived appetite and hunger.
- Conditions
- Health Behavior
- Being tested
- Traditional Exercise Training, Daily Microbursts of Activity
- Keywords
- Sedentary Behavior
- Medical subject headings
- Health Behavior, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Exercise TrainingBehavioural
Participants will be asked to perform moderate-intensity exercise (brisk walking) for 45 minutes for 5 days/week for 6 weeks. This intervention corresponds to the current recommendations.
Daily Microbursts of ActivityBehavioural
Participants will be asked to break up their sedentary activities of daily living for 5-minutes every hour for 9 hours, 5 days/week, by brisk walking for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Exercise Training | Active comparator | Participants will be asked to perform moderate-intensity exercise (brisk walking) for 45 minutes for 5 days/week for 6 weeks. This intervention corresponds to the current recommendations. Receives: Behavioral: Traditional Exercise Training |
| Daily Microbursts of Activity | Experimental | Participants will be asked to break up their sedentary activities of daily living for 5-minutes every hour for 9 hours, 5 days/week, by brisk walking for 6 weeks. Receives: Behavioral: Daily Microbursts of Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in sedentary time as measured by ActiPAL
Over each 2 week period, participants will be instructed to wear an ActiPAL (PALTechnologies: Glasgow, Scotland) activity monitor on their right leg. Participants will be instructed to wear the monitors at all times except when sleeping or participating in water-based activities. The time-stamped "event" data file from the activPAL software will be used to determine time spent sitting/lying, standing and stepping per day.
Measured: weeks 1-2 and weeks 5-6
Changes in insulin sensitivity
Insulin sensitivity will be determined via an insulin modified frequently sampled intra-venous glucose tolerance test (IVGTT). After baseline samples, intravenous glucose (0.3 g/kg) will be infused over 1 minute, followed by insulin at 0.03 U/kg, 20 minutes after glucose administration. Blood samples will be frequently sampled over 5 hours, and insulin sensitivity will be calculated using the Bergman minimal model.
Measured: Week 2 and week 8
Postprandial glycemia
Incremental area under the curve of plasma glucose concentration measured in fasting and every hour for 14 hours.
Measured: Week 2 and week 8
Secondary outcomes (12)
Changes in total energy expenditure (TEE)
Total energy expenditure (TEE) will be measured before and at the end of the intervention using doubly labeled water (DLW) over a 10-day period, as previously described (31). Subjects will ingest premixed 2g/kg total body water (TBW), estimated as 73% of fat free mass) dose of DLW composed of 0.2 and 0.15 g/kg estimated TBW of H218O and 2H2O, respectively. Urine samples will be collected in duplicate on days 0, 6, 8 and 10. 2H and 18O enrichment will be determined in urine samples by isotope ratio mass spectrometry (Delta V Advantage IRMS)
Measured: week 1-2 and week 5-6
Changes in Moderate-to-vigorous physical activity as measured by ActiGraph
Over the same 10-day period, participants will be instructed to wear an Actigraph GT3X+ accelerometer (Actigraph, LLC, Fort Walton Beach, FL) on their hip. Participants will be instructed to wear the monitors at all times except when sleeping or participating in water-based activities.
Measured: weeks 1-6
24hr substrate oxidation and energy expenditure
Gas exchange are measured for 24hr by whole room calorimetry and nitrogen excretion is measured in the urines collected for 24hr.
24hr energy expenditure is then calculated using 24hr VCO2, 24hr VO2 and 24hr urinary nitrogen excretion with the Weir equation.
24hr carbohydrate, fat and protein oxidation are calculated using 24hr VCO2, 24hr VO2 and 24hr urinary nitrogen excretion with the Frayn equation.
Measured: Week 2 and week 8
Changes in Dietary Carbohydrate Oxidation
After the investigators have shown the subjects the procedure, subjects will collect their own hourly breath sampling for CO2 by blowing through a straw into two 15ml Vacutainers. Breath CO2 will be sampled directly from the Vacutainer with a syringe, and 13CO2 /12CO2 measured with IRMS.
Measured: week 2 and week 8
Changes in Dietary Fat Oxidation
Hourly urine sampling will be collected by the subjects for 24 hours and stored in 5mL cryovials at -20C until further analysis. To measure 2 hour fat oxidation, 2 hour/1 hour ratios from urine samples will be analyzed, as above described for the doubly labeled water method. The oxidation rate of glucose/water will be calculated from the cumulative recovery of 2 hours in total body water (TBW) as detailed previously.
Measured: week 2 and week 8
Postprandial insulinemia
Incremental area under the curve of plasma insulin concentration measured in fasting and every hour for 14 hours.
Measured: Week 2 and week 8
Postprandial NEFA
Incremental area under the curve of plasma NEFA as measured in fasting state and every hour for 14 hours.
Measured: Week 2 and week 8
Postprandial triglyceridemia
Incremental area under the curve of plasma TG as measured in fasting state and every hour for 14 hours.
Measured: Week 2 and week 8
Daily glucose mean and oscillation
Daily interstitial glucose mean and oscillations as measured by continuous glucose monitoring for 14 consecutive days.
Measured: Weeks 1-2 and weeks 5-6
Changes in Mitochondria function
Freshly isolated skeletal muscle biopsies will be cut into small samples, the fibre bundles separated mechanically and partially teased apart and permeabilised. Small samples (2-5mg) will be added to the 2ml chamber of an Oroboros high-resolution respirometer with a mitochondrial respiration buffer. With the addition of several substrates, different states will be reached to analyse mitochondrial function. Pyruvate, malate and glutamate will be added as substrates to examine respiration through Complex I, succinate will be used to examine respiration through Complex II and octanoylcarnitine will be used to examine respiration through the electron-transferring flavoprotein, ETF.
Measured: week 2 and week 7
Changes in plasma inflammatory markers
Fasting blood samples will be obtained for the measurements of Interleukin 1 alpha (IL1a), Interleukin 6 (IL6), Interleukin 10 (IL10), Tumour Necrosis Factor alpha (TNFa) and cardiometabolic (triglycerides, cholesterol, C-Reactive Protein (CRP).
Measured: Week 2 and week 8
changes in plasma total cholesterol, HDL and LDL
Fasting plasma blood draw for the measurement of total cholesterol, HDL and LDL.
Measured: Week 2 and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study start9 May 2017
- Primary completion8 Oct 2021
- Study completion8 Oct 2021
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 Health BehaviorStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Audrey Bergouignan, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998892
- Sponsor's protocol ID
- 16-1769
- Status last verified
- Nov 2024
- First submitted
- 2 Dec 2016
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Santo Andre HC, Le Roux E, De Jong NP, Smith PR, Lange AH, Mendez C, Zahariev A, Mamele ML, Johnson G, Pan Z, Simon C, Bessesen DH, Pinto AJ, Bergouignan A. Frequent Versus Single Active Bouts Differentially Affect Movement Behavior and Energy Balance in Adults With Overweight/Obesity. Obesity (Silver Spring). 2026 Oct 6. doi: 10.1002/oby.70310. Online ahead of print.
PubMed 42838926
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Microbouts of Activity on Metabolic Health
- ClinicalTrials.gov ID
- NCT02998892
- Acronym / sponsor ID
- 16-1769
- Conditions
- Health Behavior
- Keywords
- Sedentary Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 9 May 2017 (actual)
- Primary completion
- 8 Oct 2021 (actual)
- Study completion
- 8 Oct 2021 (actual)
- First posted
- 21 Dec 2016 (estimated)
- 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.
Population studies suggest that time spent in sedentary behaviors is associated with all-cause mortality including obesity, diabetes, and cardiovascular diseases, independent of time spent in exercise. Frequent interruptions to sedentary time are however beneficially associated with metabolic health outcomes, even in individuals who exercise regularly. The goal is to use integrative approach to understand the biological mechanisms that underlie these associations in a longitudinal intervention study in overweight sedentary adults. The investigators believe that the proposed study will provide an initial evidence base for the health benefits of breaking up prolonged sitting with short bursts of activity. This innovative strategy may be more effective at combating the adverse effects of sedentary behaviors than more traditional approaches.
Detailed description
To compare the effects of 6-weeks of microbursts of moderate-intensity activity to a calorically equivalent single bout of 45 minutes of moderate-intensity exercise training, both performed 5 days per week for a total of 45 minutes, in free-living sedentary overweight adults on:
Aim 1: plasma inflammatory and cardiometabolic health biomarkers in association with total energy expenditure and time spent in sedentary behaviors.
H1: Microbursts of activity will result in higher daily energy expenditure and lower time spent sedentary, as respectively measured with doubly labeled water and accelerometry, than traditional exercise training. This will be associated with healthier inflammatory Interleukin 1 alpha (IL1a), Interleukin 6 (IL6), Interleukin 10 (IL10), Tumour Necrosis Factor alpha (TNFa) and cardiometabolic (triglycerides, cholesterol, C-Reactive Protein (CRP), High-density lipoprotein (HDL), and Low-density lipoprotein (LDL) profiles compared to those obtained with traditional exercise training program.
Aim 2: 24-hr total fat and carbohydrate oxidation, exogenous carbohydrate oxidation, dietary fat trafficking between oxidation and incorporation into muscle lipid fractions, and mitochondrial function.
H2: Both one single continuous bout and microbouts of activity will increase 24-hr total (whole-room calorimetry) and dietary (D31-palmitate) fat oxidation due to greater mitochondrial lipid oxidation (high resolution respirometry) and lower incorporation of dietary fatty acid into muscle lipid fractions (D31-palmitate), as compared to baseline sedentary control condition. Microbouts of activity will further result in greater increases in 24-hr total (whole-room calorimetry) and exogenous (U-13C6 glucose) carbohydrate oxidation and in mitochondrial carbohydrate-linked oxidation, than traditional isocaloric exercise training.
Aim 3: Whole-body insulin sensitivity and daily glucose mean and variability. H3: Both one single continuous bout and microbouts of activity will improve whole-body insulin sensitivity Intravenous Glucose Tolerance Test (IVGTT) compared to the baseline sedentary condition, but the improvement will likely be higher with the microbouts of activity. However, only the microbouts of activity will improve postprandial glycemia and the daily oscillations in glucose level as measured by CGM.
Exploratory aim: Self-perceived appetite and hunger.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Exercise Training | Active comparator | Behavioral: Traditional Exercise TrainingParticipants will be asked to perform moderate-intensity exercise (brisk walking) for 45 minutes for 5 days/week for 6 weeks. This intervention corresponds to the current recommendations. |
| Daily Microbursts of Activity | Experimental | Behavioral: Daily Microbursts of ActivityParticipants will be asked to break up their sedentary activities of daily living for 5-minutes every hour for 9 hours, 5 days/week, by brisk walking for 6 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Overweight but weight stable (+/- 3kg over previous 6 months) sedentary male and female adults (n=30) will be recruited.
- Ages between 18-45 years old
- BMI of 25-35 kg/m2
- Sedentary ( self report < 150min/wk of moderate-to-vigorous activity or less than 6,500 steps per day as measured for 5 days in free-living conditions with a pedometer).
- The use of birth pill control will be accepted
Key exclusion criteria (14 listed)
- Any history of renal (present or past kidney failure, kidney transplant, dialysis or kidney cysts),
- Uncontrolled hypertension
- Cardiovascular (present or past atherosclerosis, heart attack, ischemic stroke, heart failure)
- Hepatic diseases (past or present hepatitis B or C, fibrosis, cirrhosis, NAFLD/NASH)
- Type 1 or 2 diabetes
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 |
|---|---|---|
| Traditional Exercise TrainingParticipants will be asked to perform moderate-intensity exercise (brisk walking) for 45 minutes for 5 days/week for 6 weeks. This intervention corresponds to the current recommendations. | Behavioural | Traditional Exercise Training |
| Daily Microbursts of ActivityParticipants will be asked to break up their sedentary activities of daily living for 5-minutes every hour for 9 hours, 5 days/week, by brisk walking for 6 weeks. | Behavioural | Daily Microbursts of Activity |
Primary outcome
Changes in sedentary time as measured by ActiPAL
Time frame: weeks 1-2 and weeks 5-6
Over each 2 week period, participants will be instructed to wear an ActiPAL (PALTechnologies: Glasgow, Scotland) activity monitor on their right leg. Participants will be instructed to wear the monitors at all times except when sleeping or participating in water-based activities. The time-stamped "event" data file from the activPAL software will be used to determine time spent sitting/lying, standing and stepping per day.
Changes in insulin sensitivity
Time frame: Week 2 and week 8
Insulin sensitivity will be determined via an insulin modified frequently sampled intra-venous glucose tolerance test (IVGTT). After baseline samples, intravenous glucose (0.3 g/kg) will be infused over 1 minute, followed by insulin at 0.03 U/kg, 20 minutes after glucose administration. Blood samples will be frequently sampled over 5 hours, and insulin sensitivity will be calculated using the Bergman minimal model.
Postprandial glycemia
Time frame: Week 2 and week 8
Incremental area under the curve of plasma glucose concentration measured in fasting and every hour for 14 hours.
12 secondary outcomes
Changes in total energy expenditure (TEE)
Time frame: week 1-2 and week 5-6
Changes in Moderate-to-vigorous physical activity as measured by ActiGraph
Time frame: weeks 1-6
24hr substrate oxidation and energy expenditure
Time frame: Week 2 and week 8
Changes in Dietary Carbohydrate Oxidation
Time frame: week 2 and week 8
Changes in Dietary Fat Oxidation
Time frame: week 2 and week 8
Postprandial insulinemia
Time frame: Week 2 and week 8
Postprandial NEFA
Time frame: Week 2 and week 8
Postprandial triglyceridemia
Time frame: Week 2 and week 8
Daily glucose mean and oscillation
Time frame: Weeks 1-2 and weeks 5-6
Changes in Mitochondria function
Time frame: week 2 and week 7
Changes in plasma inflammatory markers
Time frame: Week 2 and week 8
changes in plasma total cholesterol, HDL and LDL
Time frame: Week 2 and week 8
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 18 Nov 2024.
- Derived from this study: PubMed 42838926Santo Andre HC, Le Roux E, De Jong NP, Smith PR, Lange AH, Mendez C, Zahariev A, Mamele ML, Johnson G, Pan Z, Simon C, Bessesen DH, Pinto AJ, Bergouignan A. Frequent Versus Single Active Bouts Differentially Affect Movement Behavior and Energy Balance in Adults With Overweight/Obesity. Obesity (Silver Spring). 2026 Oct 6. doi: 10.1002/oby.70310. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Health Behavior
Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
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.
Audrey Bergouignan, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Exercise Training and Daily Microbursts of Activity in people with Health Behavior, run by University of Colorado, Denver 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 5 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 18 Nov 2024. 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?
Changes in sedentary time as measured by ActiPAL (time frame: weeks 1-2 and weeks 5-6). 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?
On the ClinicalTrials.gov record for NCT02998892, 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 18 Nov 2024.