Sedentary LifestyleSBHONCT03153930
Sedentary Behavior and Health Outcomes Study
A study testing Walking breaks and Sitting only in people with Sedentary Lifestyle and Metabolic Disturbance, run by University of Southern California at 1 site in United States.
Trial summary
This study is a randomized crossover trial to compare the effectiveness of interrupting SB on glucose homeostasis in the lab and free-living settings. All participants (N=56) will complete one screening visit to determine eligibility, complete at fitness test, and body composition analysis by bioelectrical impedance. Read more about this study
- Who is it for?
- Ages 11 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle, Metabolic Disturbance, Pediatric Obesity
- What is being tested?
- Walking breaks and Sitting only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 30 Jun 2020
- 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 11 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- current/past participant in the MATCH Study
- good general health
- fasting plasma glucose <100 mg/dL
- BMI greater than the 5th percentile
Who cannot join
- significant cardiac or pulmonary disease likely to or resulting in hypoxia or decreased perfusion
- evidence of impaired glucose tolerance or type 2 diabetes
- presence of other endocrinologic disorders leading to obesity (e.g.: Cushing Syndrome)
- current or past anti-psychotic drugs use that would affect metabolism
- non-diet treatment for hypertension or dyslipidemia
- precocious puberty and/or receiving androgen and estrogen therapy
- medication use known to affect body composition/weight
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California Keck School of Medicine
Los Angeles, California, 90032
About this study
Official title: Metabolic Effects of Interrupting Sedentary Time in Youth In-lab and in Free-living Settings
This study is a randomized crossover trial to compare the effectiveness of interrupting SB on glucose homeostasis in the lab and free-living settings. All participants (N=56) will complete one screening visit to determine eligibility, complete at fitness test, and body composition analysis by bioelectrical impedance. After 7-21 days, all participants will complete two 3-hour in-lab oral glucose tolerance tests (spaced 7-21 days apart). Prior to the in-lab OGTT visits, participants will wear an activity monitor for 7 days on the right thigh. The experimental conditions for the OGTTs will be: 1) 3-hour OGTT of continuous sitting; and 2) 3-hour OGTT with sitting interrupted every 30 minutes with 3-minutes of moderate intensity walking on a treadmill. There will be a 7-21 day washout period between the OGTT visits. In addition, a subset of participants (N=12) who meet inclusion criteria and who successfully complete both OGTT visits will complete a second randomized crossover trial in the free-living environment. The experimental conditions for the free-living components will be: 1) 4 days of habitual sedentary behaviors; and 2) 4 days of prompted short exercise breaks during times in which sedentary behaviors have exceeded 30 minutes. Participants in the free-living trial will wear an activity monitor and a continuous glucose monitor.
Read the detailed description
Rationale: Sedentary behavior (SB) can increase risk for type 2 diabetes. Interrupting SB is a promising strategy to reduce risk, but the long-term success is not yet clear and data on the relationship between in-lab and free-living metabolic responses are lacking. A better understanding of the relationship between metabolic responses to sitting and interrupting sitting in the lab and in a naturalistic environment will help us design effective and targeted intervention strategies to prevent type 2 diabetes in youth.
Intervention: Participants (28 healthy weight and 28 overweight/obese youth; ages 11-15 years) from an ongoing longitudinal observational study (HS-12-00446) will complete: a) an in-lab randomized crossover trial of acute metabolic responses to prolonged vs. SB interruptions; and a subset (N=12) will complete b) two 4-day continuous glucose monitoring (CGM) studies of effects of free-living habitual activity vs. SB interruptions on glucose homeostasis.
Objectives/Purpose: The overall goal is to improve metabolic outcomes by interrupting SB in youth with small bouts of exercise. The aim of this study is to investigate whether the metabolic responses to interrupting sitting are the same in a controlled lab setting and a free-living setting. This study will also try to explain why some children respond better to these short interruptions in sitting than others by using three years of physical activity, body fat, and weight trajectory data from an ongoing study (HS-12-00446).
Study Population: The study population will consist of participants currently enrolled in the Mothers and Their Children's Health (MATCH) Study (PI: Dunton; HS-12-00446; ages 11-15 years).Eligible participants will have completed 3 years of semi-annual assessments of body composition, physical activity, and dietary intake in the MATCH study.
Study Methodology: This study is a randomized crossover trial to compare the effectiveness of interrupting SB on glucose homeostasis in the lab and free-living settings. All participants (N=56) will complete one screening visit to determine eligibility, complete at fitness test, and body composition analysis by bioelectrical impedance. After 7-21 days, all participants will complete two 3-hour in-lab oral glucose tolerance tests (spaced 7-21 days apart). Prior to the in-lab OGTT visits, participants will wear an activity monitor for 7 days on the right thigh. The experimental conditions for the OGTTs will be: 1) 3-hour OGTT of continuous sitting; and 2) 3-hour OGTT with sitting interrupted every 30 minutes with 3-minutes of moderate intensity walking on a treadmill. There will be a 7-21 day washout period between the OGTT visits. In addition, a subset of participants (N=12) who meet inclusion criteria and who successfully complete both OGTT visits will complete a second randomized crossover trial in the free-living environment. The experimental conditions for the free-living components will be: 1) 4 days of habitual sedentary behaviors; and 2) 4 days of prompted short exercise breaks during times in which sedentary behaviors have exceeded 30 minutes. Participants in the free-living trial will wear an activity monitor and a continuous glucose monitor.
Study Arms: Participants will be assigned to receive in random order the continuous sitting test at the first visit and the sitting interruptions test on the second visit, or vice versa. The order of the free-living conditions will be the same as the in-lab condition order.
Endpoints/Outcomes: The primary endpoints are: insulin, C-peptide, and glucose area under the curve (AUC) in the in-lab experiments, and glucose AUC in the free-living experiments.
Follow-up: Study duration for those completing only the in-lab experiments is a minimum of 17 days and a maximum of 45 days to complete. For the subset of participants who are additionally completing the free-living component, the study duration is a minimum of 25 days and a maximum of 53 days.
Statistical Analyses: The populations for analyses include the full analytical dataset which consists of all randomized study participants, with the exception of those participants in the parent MATCH study who are not participating in this research study.
- Being tested
- Walking breaks, Sitting only
- Keywords
- sedentary behavior, youth, moderating factors, metabolic outcomes
- Medical subject headings
- Sedentary Behavior, Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking breaksBehavioural
Also called Interrupting sedentary time
In-Lab (full sample): participants will be asked to walk on a treadmill for 3 minutes every 30 minutes at a moderate pace during a 3-hour OGTT Free-living (sub-sample; N=12): participants will be prompted via an ActivPAL vtap monitor to walk for 3 minutes every time sedentary behavior lasts longer than 30 continuous minutes
Sitting onlyBehavioural
Also called Continuous sedentary time
In-Lab (full sample): participants will remain seated for 3 hours during an OGTT Free-living (sub-sample; N=12): participants will perform their habitual sedentary behaviors
| Study group | Role | What they receive |
|---|---|---|
| Sitting Only (SIT) | Placebo comparator | In-Lab (full sample): children will sit continuously for 3 hours during an OGTT Free-living (sub-sample; N=12): children will complete their habitual sedentary behaviors over 4 days; they will also wear a continuous glucose monitor Receives: Behavioral: Sitting only |
| Walking Breaks (WALK) | Experimental | In-Lab (full sample): children will be asked to walk on a treadmill every 30 minutes for 3 minute bouts during a 3 hour OGTT Free-living (sub-sample; N=12): children will be prompted with an ActivPAL vtap monitor on the right thigh to perform 3-minute walking bouts whenever sedentary time has lasted longer than 30 minutes over 4 days; they will also wear a continuous glucose monitor Receives: Behavioral: Walking breaks |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-Lab: Metabolic responses
glucose, insulin, and c-peptide area under the curve
Measured: 3 hours
Free-living: Glucose responses
glucose area under the curve
Measured: 4 days
Predictors of in-lab glucose responses
Independent-sample t-tests will assess if mean in-lab glucose AUC differs within experimental condition by weight status (normal weight or overweight/obese). Independent-sample t-tests will assess if mean AUC values between conditions (delta AUC) differ by weight status. Structural equation models of latent growth curves will be used to assess the relationship between BMI z-score trajectories in the preceding 3 years, in-lab glucose AUC responses by experimental condition. Specifically, models will test if a) the higher the initial BMI z score (year 1), the higher the initial serum value (-10 min); b) the higher the initial BMI z score (year 1), the greater the change in serum AUC between experimental conditions; and c) the greater slope of the BMI z score change, the greater the change in serum AUC between experimental conditions.
Measured: 3 years
Individual variations in glucose responses in-lab
Mixed-effects location scale models (MIXREGLS) will test how between-subject (BS) and within-subject (WS) variation in SB in the preceding 3 years are associated with glucose responses to in-lab SB interruptions. The predictors are average 3-year SB level and SB level at each year (variation in SB). The Stage 1 mixed-effects location scale model will examine random effects of between-subject variance (i.e., location) and of within-subject variance (i.e., scale), sex, baseline percent body fat, and baseline age. The Stage 2 model will assess how these variance sources from Stage 1 affect the delta AUC between in-lab prolonged SB and SB interruptions with regards to glucose (the WS effects).
Measured: 3 years
Secondary outcomes (1)
Relationship between in-lab and free-living glucose AUC
We will assess bivariate correlations between the in-lab glucose AUC and the first day of in-field glucose AUC. Linear regression will be used to estimate associations between in-lab glucose AUC responses and the first day of free-living cumulative glucose AUC. Because we will have repeated measures (4 days) of cumulative glucose AUC values in the field, mixed models will be used to assess the effects of in-lab glucose AUC on glucose responses to SB interruptions over 4 time points (day 1, 2, 3, and 4).
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start1 Jan 2018
- Primary completion1 Jun 2020
- Study completion30 Jun 2020
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 Sedentary LifestyleStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will complete a randomized crossover study with 2 conditions: sitting continuously for 3 hours vs. interrupting sitting with 3-minute moderate intensity walking breaks every 30 minutes for 3 hours. A subset will then complete a free-living component wearing a continuous glucose monitor that will consist of habitual activity vs. interrupting periods of 30+ sedentary minutes with short activity breaks.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Britni Ryan Belcher, PhD, MPH, University of Southern California
- Investigators
- Britni R Belcher, PhD, MPH, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153930
- Sponsor's protocol ID
- 1K01DK113062
- Acronym
- SBHO
- Status last verified
- Nov 2020
- First submitted
- 12 May 2017
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not intend to share IPD with other researchers outside of our study.
Publications
McAlister KL, Zink J, Huh J, Yang CH, Dunton GF, Dieli-Conwright CM, Page KA, Belcher BR. Perceived stress and associations between physical activity, sedentary time, and interstitial glucose in healthy adolescents. Physiol Behav. 2024 Sep 1;283:114617. doi: 10.1016/j.physbeh.2024.114617. Epub 2024 Jun 16.
PubMed 38889810
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Interrupting Sedentary Time in Youth In-lab and in Free-living Settings
- ClinicalTrials.gov ID
- NCT03153930
- Acronym / sponsor ID
- SBHO / 1K01DK113062
- Keywords
- sedentary behavior, youth, moderating factors, metabolic outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 15 May 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.
This study is a randomized crossover trial to compare the effectiveness of interrupting SB on glucose homeostasis in the lab and free-living settings. All participants (N=56) will complete one screening visit to determine eligibility, complete at fitness test, and body composition analysis by bioelectrical impedance. After 7-21 days, all participants will complete two 3-hour in-lab oral glucose tolerance tests (spaced 7-21 days apart). Prior to the in-lab OGTT visits, participants will wear an activity monitor for 7 days on the right thigh. The experimental conditions for the OGTTs will be: 1) 3-hour OGTT of continuous sitting; and 2) 3-hour OGTT with sitting interrupted every 30 minutes with 3-minutes of moderate intensity walking on a treadmill. There will be a 7-21 day washout period between the OGTT visits. In addition, a subset of participants (N=12) who meet inclusion criteria and who successfully complete both OGTT visits will complete a second randomized crossover trial in the free-living environment. The experimental conditions for the free-living components will be: 1) 4 days of habitual sedentary behaviors; and 2) 4 days of prompted short exercise breaks during times in which sedentary behaviors have exceeded 30 minutes. Participants in the free-living trial will wear an activity monitor and a continuous glucose monitor.
Detailed description
Rationale: Sedentary behavior (SB) can increase risk for type 2 diabetes. Interrupting SB is a promising strategy to reduce risk, but the long-term success is not yet clear and data on the relationship between in-lab and free-living metabolic responses are lacking. A better understanding of the relationship between metabolic responses to sitting and interrupting sitting in the lab and in a naturalistic environment will help us design effective and targeted intervention strategies to prevent type 2 diabetes in youth.
Intervention: Participants (28 healthy weight and 28 overweight/obese youth; ages 11-15 years) from an ongoing longitudinal observational study (HS-12-00446) will complete: a) an in-lab randomized crossover trial of acute metabolic responses to prolonged vs. SB interruptions; and a subset (N=12) will complete b) two 4-day continuous glucose monitoring (CGM) studies of effects of free-living habitual activity vs. SB interruptions on glucose homeostasis.
Objectives/Purpose: The overall goal is to improve metabolic outcomes by interrupting SB in youth with small bouts of exercise. The aim of this study is to investigate whether the metabolic responses to interrupting sitting are the same in a controlled lab setting and a free-living setting. This study will also try to explain why some children respond better to these short interruptions in sitting than others by using three years of physical activity, body fat, and weight trajectory data from an ongoing study (HS-12-00446).
Study Population: The study population will consist of participants currently enrolled in the Mothers and Their Children's Health (MATCH) Study (PI: Dunton; HS-12-00446; ages 11-15 years).Eligible participants will have completed 3 years of semi-annual assessments of body composition, physical activity, and dietary intake in the MATCH study.
Study Methodology: This study is a randomized crossover trial to compare the effectiveness of interrupting SB on glucose homeostasis in the lab and free-living settings. All participants (N=56) will complete one screening visit to determine eligibility, complete at fitness test, and body composition analysis by bioelectrical impedance. After 7-21 days, all participants will complete two 3-hour in-lab oral glucose tolerance tests (spaced 7-21 days apart). Prior to the in-lab OGTT visits, participants will wear an activity monitor for 7 days on the right thigh. The experimental conditions for the OGTTs will be: 1) 3-hour OGTT of continuous sitting; and 2) 3-hour OGTT with sitting interrupted every 30 minutes with 3-minutes of moderate intensity walking on a treadmill. There will be a 7-21 day washout period between the OGTT visits. In addition, a subset of participants (N=12) who meet inclusion criteria and who successfully complete both OGTT visits will complete a second randomized crossover trial in the free-living environment. The experimental conditions for the free-living components will be: 1) 4 days of habitual sedentary behaviors; and 2) 4 days of prompted short exercise breaks during times in which sedentary behaviors have exceeded 30 minutes. Participants in the free-living trial will wear an activity monitor and a continuous glucose monitor.
Study Arms: Participants will be assigned to receive in random order the continuous sitting test at the first visit and the sitting interruptions test on the second visit, or vice versa. The order of the free-living conditions will be the same as the in-lab condition order.
Endpoints/Outcomes: The primary endpoints are: insulin, C-peptide, and glucose area under the curve (AUC) in the in-lab experiments, and glucose AUC in the free-living experiments.
Follow-up: Study duration for those completing only the in-lab experiments is a minimum of 17 days and a maximum of 45 days to complete. For the subset of participants who are additionally completing the free-living component, the study duration is a minimum of 25 days and a maximum of 53 days.
Statistical Analyses: The populations for analyses include the full analytical dataset which consists of all randomized study participants, with the exception of those participants in the parent MATCH study who are not participating in this research study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will complete a randomized crossover study with 2 conditions: sitting continuously for 3 hours vs. interrupting sitting with 3-minute moderate intensity walking breaks every 30 minutes for 3 hours. A subset will then complete a free-living component wearing a continuous glucose monitor that will consist of habitual activity vs. interrupting periods of 30+ sedentary minutes with short activity breaks.
| Arm | Type | Receives |
|---|---|---|
| Sitting Only (SIT) | Placebo comparator | Behavioral: Sitting onlyIn-Lab (full sample): children will sit continuously for 3 hours during an OGTT Free-living (sub-sample; N=12): children will complete their habitual sedentary behaviors over 4 days; they will also wear a continuous glucose monitor |
| Walking Breaks (WALK) | Experimental | Behavioral: Walking breaksIn-Lab (full sample): children will be asked to walk on a treadmill every 30 minutes for 3 minute bouts during a 3 hour OGTT Free-living (sub-sample; N=12): children will be prompted with an ActivPAL vtap monitor on the right thigh to perform 3-minute walking bouts whenever sedentary time has lasted longer than 30 minutes over 4 days; they will also wear a continuous glucose monitor |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- current/past participant in the MATCH Study
- good general health
- fasting plasma glucose <100 mg/dL
- BMI greater than the 5th percentile
Key exclusion criteria (7 listed)
- significant cardiac or pulmonary disease likely to or resulting in hypoxia or decreased perfusion
- evidence of impaired glucose tolerance or type 2 diabetes
- presence of other endocrinologic disorders leading to obesity (e.g.: Cushing Syndrome)
- current or past anti-psychotic drugs use that would affect metabolism
- non-diet treatment for hypertension or dyslipidemia
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 |
|---|---|---|
| Walking breaksAlso: Interrupting sedentary timeIn-Lab (full sample): participants will be asked to walk on a treadmill for 3 minutes every 30 minutes at a moderate pace during a 3-hour OGTT Free-living (sub-sample; N=12): participants will be prompted via an ActivPAL vtap monitor to walk for 3 minutes every time sedentary behavior lasts longer than 30 continuous minutes | Behavioural | Walking Breaks (WALK) |
| Sitting onlyAlso: Continuous sedentary timeIn-Lab (full sample): participants will remain seated for 3 hours during an OGTT Free-living (sub-sample; N=12): participants will perform their habitual sedentary behaviors | Behavioural | Sitting Only (SIT) |
Primary outcome
In-Lab: Metabolic responses
Time frame: 3 hours
glucose, insulin, and c-peptide area under the curve
Free-living: Glucose responses
Time frame: 4 days
glucose area under the curve
Predictors of in-lab glucose responses
Time frame: 3 years
Independent-sample t-tests will assess if mean in-lab glucose AUC differs within experimental condition by weight status (normal weight or overweight/obese). Independent-sample t-tests will assess if mean AUC values between conditions (delta AUC) differ by weight status. Structural equation models of latent growth curves will be used to assess the relationship between BMI z-score trajectories in the preceding 3 years, in-lab glucose AUC responses by experimental condition. Specifically, models will test if a) the higher the initial BMI z score (year 1), the higher the initial serum value (-10 min); b) the higher the initial BMI z score (year 1), the greater the change in serum AUC between experimental conditions; and c) the greater slope of the BMI z score change, the greater the change in serum AUC between experimental conditions.
Individual variations in glucose responses in-lab
Time frame: 3 years
Mixed-effects location scale models (MIXREGLS) will test how between-subject (BS) and within-subject (WS) variation in SB in the preceding 3 years are associated with glucose responses to in-lab SB interruptions. The predictors are average 3-year SB level and SB level at each year (variation in SB). The Stage 1 mixed-effects location scale model will examine random effects of between-subject variance (i.e., location) and of within-subject variance (i.e., scale), sex, baseline percent body fat, and baseline age. The Stage 2 model will assess how these variance sources from Stage 1 affect the delta AUC between in-lab prolonged SB and SB interruptions with regards to glucose (the WS effects).
1 secondary outcome
Relationship between in-lab and free-living glucose AUC
Time frame: 5 days
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 13 Nov 2020.
- Derived from this study: PubMed 38889810McAlister KL, Zink J, Huh J, Yang CH, Dunton GF, Dieli-Conwright CM, Page KA, Belcher BR. Perceived stress and associations between physical activity, sedentary time, and interstitial glucose in healthy adolescents. Physiol Behav. 2024 Sep 1;283:114617. doi: 10.1016/j.physbeh.2024.114617. Epub 2024 Jun 16.
- Individual participant dataSharing planned: No. We do not intend to share IPD with other researchers outside of our study.
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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.
Britni R Belcher, PhD, MPH principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking breaks and Sitting only in people with Sedentary Lifestyle and Metabolic Disturbance, run by University of Southern California 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 4 inclusion and 7 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 13 Nov 2020. 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. Some participants in this study may receive a placebo. 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?
In-Lab: Metabolic responses (time frame: 3 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03153930, 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 13 Nov 2020.