SleepNCT02960776
Impact of Sleep Restriction on Performance in Adults
A study testing Sleep Restriction (SR) in people with Sleep and Obesity, run by Columbia University at 1 site in United States.
Trial summary
The overall goal of this project is to look at the effects of long-term, sustained sleep restriction (SR) in adults, and assess the effects on mood and cognitive and physical performance. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Obesity, Sleep Restriction
- What is being tested?
- Sleep Restriction (SR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2016to 5 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 25-29.9 kg/m2
- Have at least one obese parent
- Habitually sleep 7-9 hours a night
- Free of any current and past sleep and psychiatric disorders, including eating disorders, diabetes or Cardiovascular disease (CVD) (i.e., normal scores on: Pittsburgh Quality of Sleep Questionnaire Epworth Sleepiness Scale, Berlin Questionnaire, Sleep Disorders Inventory Questionnaire, Beck Depression Inventory, Composite Scale of Morningness/Eveningness, Three Factor Eating Questionnaire)
- All racial/ethnic groups
Who cannot join
- Smokers (any cigarettes or ex-smoker < 3 years)
- Neurological, medical or psychiatric disorder
- Diabetics
- Eating and/or sleep disorders
- Contraindications for MRI scanning
- Travel across time zones within 4 weeks
Show all 11Show fewer
- History of drug and alcohol abuse
- Shift worker (or rotating shift worker)
- Caffeine intake > 300 mg/d
- Heavy equipment operators
- Commercial long-distance drivers
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Nutrition Obesity Research Center
New York, New York, 10032
About this study
Official title: Effect of Long Term Sleep Restriction on Energy Balance
The overall goal of this project is to look at the effects of long-term, sustained sleep restriction (SR) in adults, and assess the effects on mood and cognitive and physical performance.
Read the detailed description
Chronic Sleep Restriction (SR) is highly prevalent in today's modern society. Artificial light, portable electronic devices, and 24-h services have allowed individuals to remain active throughout the night, leading to reductions in sleep duration. SSD has been linked to obesity and our laboratory has been interested in establishing whether sleep could be a causal factor in the etiology of obesity. Given the increasing prevalence of obesity over the past 5 decades, coinciding with the marked reduction in sleep duration, further exploration into the role of sleep as a risk factor for obesity could provide additional ammunition in the fight to prevent further increases in the incidence of obesity.
This study will be a randomized, crossover, outpatient SR study with 2 phases of 6 weeks each, with a 6 week wash-out period between the phases. Sleep duration in each phase will be the participant's regular bed- and wake times during the habitual sleep (HS) phase and HS minus 1.5 hours in the SR phase. During the HS phase, participants will be asked to follow a fixed bedtime routine based on their screening sleep schedule. During the SR phase, participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time.
- Conditions
- Sleep, Obesity, Sleep Restriction
- Being tested
- Sleep Restriction (SR)
- Keywords
- Body Weight, Habitual sleep
- Medical subject headings
- Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Restriction (SR)Behavioural
Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time. A delay in bedtimes was chosen rather than advancing wake-up time because it most closely reflects differences in sleep timing behavior between short and normal sleepers.
| Study group | Role | What they receive |
|---|---|---|
| Habitual Sleep (HS) | No intervention | Participants will be asked to follow a fixed bedtime routine based on the participant's regular bed- and wake-times during the habitual sleep (HS) phase. |
| Sleep Restriction (SR) | Experimental | Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time during the sleep restriction (SR) phase. Receives: Behavioral: Sleep Restriction (SR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endpoint Fat Volume
Body composition (specifically fat volume) will be measured by MRI at baseline and endpoint.
Measured: Week 6 (endpoint)
Secondary outcomes (9)
Energy Expenditure (EE)
EE is the amount of energy (or calories) that a person needs to carry out physical functions and will be assessed using Doubly Labeled Water (DLW), during the last 2 weeks of each sleep phase.
Measured: Measured over 14 days at the end of each phase (weeks 5 and 6; endpoint)
Physical Activity
Time spent in moderate-to-vigorous physical activity.
Measured: Average over 6 weeks (measured daily)
Ghrelin
Average post-baseline values
Measured: 6 weeks
Regional Brain Activation in Response to Food Stimuli
The primary aim of this outcome was to investigate brain activation in response to food stimuli after a six-week period of Adequate Sleep (AS) or mild Sleep Restriction (SR). To achieve this, the investigators contrasted neuronal responses to food and non-food stimuli at two time points (baseline and six weeks post-intervention/control). This contrast allowed the investigators to calculate the number of voxels activated during the view of food stimuli compared to the number of voxels activated during the view of non-food stimuli (food - non-food) under each condition (AS or SR).
Regional brain activation is reported as the total number of voxels activated on the group contrast images (combination of all analyzed participants) of the neuronal response to food stimuli compared to non-food stimuli. For this analysis, voxels were considered activated if they survived Gaussian Random Field theory correction with a 2-tailed p < 0.001 threshold when creating the group contrast images.
Measured: Week 6
Sedentary Behavior
Time spent in sedentary physical activity.
Measured: Average over 6 weeks (measured daily)
Leptin
Average post-baseline values
Measured: 6 weeks
Glucagon-like Peptide 1
Average post-baseline values
Measured: 6 weeks
Orexin
Average post-baseline values
Measured: 6 weeks
Neuropeptide Y
Average post-baseline values
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2016 (estimated)
- Study start1 Nov 2016
- Primary completion5 Jul 2023
- Study completion5 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie-Pierre St-Onge, Columbia University
- Investigators
- Marie-Pierre St-Onge, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02960776
- Sponsor's protocol ID
- AAAQ7746
- Other IDs
- 1R01HL128226-01A1
- Status last verified
- Mar 2025
- First submitted
- 7 Nov 2016
- Last updated
- 3 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified data will be provided on request after discussion among parties.
Publications
Luckhaupt SE, Tak S, Calvert GM. The prevalence of short sleep duration by industry and occupation in the National Health Interview Survey. Sleep. 2010 Feb;33(2):149-59. doi: 10.1093/sleep/33.2.149.
PubMed 20175398Keith SW, Redden DT, Katzmarzyk PT, Boggiano MM, Hanlon EC, Benca RM, Ruden D, Pietrobelli A, Barger JL, Fontaine KR, Wang C, Aronne LJ, Wright SM, Baskin M, Dhurandhar NV, Lijoi MC, Grilo CM, DeLuca M, Westfall AO, Allison DB. Putative contributors to the secular increase in obesity: exploring the roads less traveled. Int J Obes (Lond). 2006 Nov;30(11):1585-94. doi: 10.1038/sj.ijo.0803326. Epub 2006 Jun 27.
PubMed 16801930Zuraikat FM, Makarem N, Redline S, Aggarwal B, Jelic S, St-Onge MP. Sleep Regularity and Cardiometabolic Heath: Is Variability in Sleep Patterns a Risk Factor for Excess Adiposity and Glycemic Dysregulation? Curr Diab Rep. 2020 Jul 23;20(8):38. doi: 10.1007/s11892-020-01324-w.
PubMed 32700156Makarem N, Zuraikat FM, Aggarwal B, Jelic S, St-Onge MP. Variability in Sleep Patterns: an Emerging Risk Factor for Hypertension. Curr Hypertens Rep. 2020 Feb 21;22(2):19. doi: 10.1007/s11906-020-1025-9.
PubMed 32086595Smith I, Salazar I, RoyChoudhury A, St-Onge MP. Sleep restriction and testosterone concentrations in young healthy males: randomized controlled studies of acute and chronic short sleep. Sleep Health. 2019 Dec;5(6):580-586. doi: 10.1016/j.sleh.2019.07.003. Epub 2019 Aug 12.
PubMed 31416797St-Onge MP, Campbell A, Salazar I, Pizinger T, Liao M, Aggarwal B. Information on Bedtimes and Wake Times Improves the Relation Between Self-Reported and Objective Assessments of Sleep in Adults. J Clin Sleep Med. 2019 Jul 15;15(7):1031-1036. doi: 10.5664/jcsm.7888.
PubMed 31383241Barragan R, Zuraikat FM, Tam V, Scaccia S, Cochran J, Li S, Cheng B, St-Onge MP. Actigraphy-Derived Sleep Is Associated with Eating Behavior Characteristics. Nutrients. 2021 Mar 5;13(3):852. doi: 10.3390/nu13030852.
PubMed 33807690Benasi G, Cheng B, Aggarwal B, St-Onge MP. The effects of sustained mild sleep restriction on stress and distress among healthy adults: Findings from two randomized crossover studies. Sleep Med. 2024 Mar;115:83-87. doi: 10.1016/j.sleep.2024.02.001. Epub 2024 Feb 2.
PubMed 38342031Zimmerman ME, Benasi G, Hale C, Yeung LK, Cochran J, Brickman AM, St-Onge MP. The effects of insufficient sleep and adequate sleep on cognitive function in healthy adults. Sleep Health. 2024 Apr;10(2):229-236. doi: 10.1016/j.sleh.2023.11.011. Epub 2024 Jan 16.
PubMed 38233280Li XY, Yoncheva Y, Yan CG, Castellanos FX, St-Onge MP. Chronic Mild Sleep Restriction Does Not Lead to Marked Neuronal Alterations Compared With Maintained Adequate Sleep in Adults. J Nutr. 2024 Feb;154(2):446-454. doi: 10.1016/j.tjnut.2023.12.016. Epub 2023 Dec 16.
PubMed 38104943Barragan R, Zuraikat FM, Cheng B, Scaccia SE, Cochran J, Aggarwal B, Jelic S, St-Onge MP. Paradoxical Effects of Prolonged Insufficient Sleep on Lipid Profile: A Pooled Analysis of 2 Randomized Trials. J Am Heart Assoc. 2023 Oct 17;12(20):e032078. doi: 10.1161/JAHA.123.032078. Epub 2023 Oct 10.
PubMed 37815115Barragan R, Zuraikat FM, Tam V, RoyChoudhury A, St-Onge MP. Changes in eating patterns in response to chronic insufficient sleep and their associations with diet quality: a randomized trial. J Clin Sleep Med. 2023 Nov 1;19(11):1867-1875. doi: 10.5664/jcsm.10696.
PubMed 37409467McAlpine CS, Kiss MG, Zuraikat FM, Cheek D, Schiroli G, Amatullah H, Huynh P, Bhatti MZ, Wong LP, Yates AG, Poller WC, Mindur JE, Chan CT, Janssen H, Downey J, Singh S, Sadreyev RI, Nahrendorf M, Jeffrey KL, Scadden DT, Naxerova K, St-Onge MP, Swirski FK. Sleep exerts lasting effects on hematopoietic stem cell function and diversity. J Exp Med. 2022 Nov 7;219(11):e20220081. doi: 10.1084/jem.20220081. Epub 2022 Sep 21.
PubMed 36129517Zuraikat FM, Scaccia SE, Cochran JA, Cheng B, Diaz KM, Creasy SA, Melanson EL, Shen W, Aggarwal B, Jelic S, St-Onge MP. Prolonged Short Sleep and Its Effect on Body Weight and Composition : A Pooled Analysis of Randomized Trials. Ann Intern Med. 2026 Jul 7. doi: 10.7326/ANNALS-25-01660. Online ahead of print.
PubMed 42407080Petrov ME, Zuraikat FM, Cheng B, Aggarwal B, Jelic S, Laferrere B, St-Onge MP. Impact of sleep restriction on biomarkers of thyroid function: Two pooled randomized trials. Sleep Med. 2024 Dec;124:606-612. doi: 10.1016/j.sleep.2024.10.035. Epub 2024 Oct 30.
PubMed 39488926
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Long Term Sleep Restriction on Energy Balance
- ClinicalTrials.gov ID
- NCT02960776
- Acronym / sponsor ID
- AAAQ7746
- Conditions
- Sleep, Obesity, Sleep Restriction
- Keywords
- Body Weight, Habitual sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- NYU Langone Health, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 10 Nov 2016 (estimated)
- Results
- Posted 9 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this project is to look at the effects of long-term, sustained sleep restriction (SR) in adults, and assess the effects on mood and cognitive and physical performance.
Detailed description
Chronic Sleep Restriction (SR) is highly prevalent in today's modern society. Artificial light, portable electronic devices, and 24-h services have allowed individuals to remain active throughout the night, leading to reductions in sleep duration. SSD has been linked to obesity and our laboratory has been interested in establishing whether sleep could be a causal factor in the etiology of obesity. Given the increasing prevalence of obesity over the past 5 decades, coinciding with the marked reduction in sleep duration, further exploration into the role of sleep as a risk factor for obesity could provide additional ammunition in the fight to prevent further increases in the incidence of obesity.
This study will be a randomized, crossover, outpatient SR study with 2 phases of 6 weeks each, with a 6 week wash-out period between the phases. Sleep duration in each phase will be the participant's regular bed- and wake times during the habitual sleep (HS) phase and HS minus 1.5 hours in the SR phase. During the HS phase, participants will be asked to follow a fixed bedtime routine based on their screening sleep schedule. During the SR phase, participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Habitual Sleep (HS) | No intervention | –Participants will be asked to follow a fixed bedtime routine based on the participant's regular bed- and wake-times during the habitual sleep (HS) phase. |
| Sleep Restriction (SR) | Experimental | Behavioral: Sleep Restriction (SR)Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time during the sleep restriction (SR) phase. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI 25-29.9 kg/m2
- Have at least one obese parent
- Habitually sleep 7-9 hours a night
- Free of any current and past sleep and psychiatric disorders, including eating disorders, diabetes or Cardiovascular disease (CVD) (i.e., normal scores on: Pittsburgh Quality of Sleep Questionnaire Epworth Sleepiness Scale, Berlin Questionnaire, Sleep Disorders Inventory Questionnaire, Beck Depression Inventory, Composite Scale of Morningness/Eveningness, Three Factor Eating Questionnaire)
- All racial/ethnic groups
Key exclusion criteria (11 listed)
- Smokers (any cigarettes or ex-smoker < 3 years)
- Neurological, medical or psychiatric disorder
- Diabetics
- Eating and/or sleep disorders
- Contraindications for MRI scanning
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 |
|---|---|---|
| Sleep Restriction (SR)Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time. A delay in bedtimes was chosen rather than advancing wake-up time because it most closely reflects differences in sleep timing behavior between short and normal sleepers. | Behavioural | Sleep Restriction (SR) |
Primary outcome
Endpoint Fat Volume
Time frame: Week 6 (endpoint)
Body composition (specifically fat volume) will be measured by MRI at baseline and endpoint.
9 secondary outcomes
Energy Expenditure (EE)
Time frame: Measured over 14 days at the end of each phase (weeks 5 and 6; endpoint)
Physical Activity
Time frame: Average over 6 weeks (measured daily)
Ghrelin
Time frame: 6 weeks
Regional Brain Activation in Response to Food Stimuli
Time frame: Week 6
Sedentary Behavior
Time frame: Average over 6 weeks (measured daily)
Leptin
Time frame: 6 weeks
Glucagon-like Peptide 1
Time frame: 6 weeks
Orexin
Time frame: 6 weeks
Neuropeptide Y
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20175398Luckhaupt SE, Tak S, Calvert GM. The prevalence of short sleep duration by industry and occupation in the National Health Interview Survey. Sleep. 2010 Feb;33(2):149-59. doi: 10.1093/sleep/33.2.149.
- Background: PubMed 16801930Keith SW, Redden DT, Katzmarzyk PT, Boggiano MM, Hanlon EC, Benca RM, Ruden D, Pietrobelli A, Barger JL, Fontaine KR, Wang C, Aronne LJ, Wright SM, Baskin M, Dhurandhar NV, Lijoi MC, Grilo CM, DeLuca M, Westfall AO, Allison DB. Putative contributors to the secular increase in obesity: exploring the roads less traveled. Int J Obes (Lond). 2006 Nov;30(11):1585-94. doi: 10.1038/sj.ijo.0803326. Epub 2006 Jun 27.
- Background: PubMed 32700156Zuraikat FM, Makarem N, Redline S, Aggarwal B, Jelic S, St-Onge MP. Sleep Regularity and Cardiometabolic Heath: Is Variability in Sleep Patterns a Risk Factor for Excess Adiposity and Glycemic Dysregulation? Curr Diab Rep. 2020 Jul 23;20(8):38. doi: 10.1007/s11892-020-01324-w.
- Background: PubMed 32086595Makarem N, Zuraikat FM, Aggarwal B, Jelic S, St-Onge MP. Variability in Sleep Patterns: an Emerging Risk Factor for Hypertension. Curr Hypertens Rep. 2020 Feb 21;22(2):19. doi: 10.1007/s11906-020-1025-9.
- Results publication: PubMed 31416797Smith I, Salazar I, RoyChoudhury A, St-Onge MP. Sleep restriction and testosterone concentrations in young healthy males: randomized controlled studies of acute and chronic short sleep. Sleep Health. 2019 Dec;5(6):580-586. doi: 10.1016/j.sleh.2019.07.003. Epub 2019 Aug 12.
- Results publication: PubMed 31383241St-Onge MP, Campbell A, Salazar I, Pizinger T, Liao M, Aggarwal B. Information on Bedtimes and Wake Times Improves the Relation Between Self-Reported and Objective Assessments of Sleep in Adults. J Clin Sleep Med. 2019 Jul 15;15(7):1031-1036. doi: 10.5664/jcsm.7888.
- Results publication: PubMed 33807690Barragan R, Zuraikat FM, Tam V, Scaccia S, Cochran J, Li S, Cheng B, St-Onge MP. Actigraphy-Derived Sleep Is Associated with Eating Behavior Characteristics. Nutrients. 2021 Mar 5;13(3):852. doi: 10.3390/nu13030852.
- Results publication: PubMed 38342031Benasi G, Cheng B, Aggarwal B, St-Onge MP. The effects of sustained mild sleep restriction on stress and distress among healthy adults: Findings from two randomized crossover studies. Sleep Med. 2024 Mar;115:83-87. doi: 10.1016/j.sleep.2024.02.001. Epub 2024 Feb 2.
- Results publication: PubMed 38233280Zimmerman ME, Benasi G, Hale C, Yeung LK, Cochran J, Brickman AM, St-Onge MP. The effects of insufficient sleep and adequate sleep on cognitive function in healthy adults. Sleep Health. 2024 Apr;10(2):229-236. doi: 10.1016/j.sleh.2023.11.011. Epub 2024 Jan 16.
- Results publication: PubMed 38104943Li XY, Yoncheva Y, Yan CG, Castellanos FX, St-Onge MP. Chronic Mild Sleep Restriction Does Not Lead to Marked Neuronal Alterations Compared With Maintained Adequate Sleep in Adults. J Nutr. 2024 Feb;154(2):446-454. doi: 10.1016/j.tjnut.2023.12.016. Epub 2023 Dec 16.
- Results publication: PubMed 37815115Barragan R, Zuraikat FM, Cheng B, Scaccia SE, Cochran J, Aggarwal B, Jelic S, St-Onge MP. Paradoxical Effects of Prolonged Insufficient Sleep on Lipid Profile: A Pooled Analysis of 2 Randomized Trials. J Am Heart Assoc. 2023 Oct 17;12(20):e032078. doi: 10.1161/JAHA.123.032078. Epub 2023 Oct 10.
- Results publication: PubMed 37409467Barragan R, Zuraikat FM, Tam V, RoyChoudhury A, St-Onge MP. Changes in eating patterns in response to chronic insufficient sleep and their associations with diet quality: a randomized trial. J Clin Sleep Med. 2023 Nov 1;19(11):1867-1875. doi: 10.5664/jcsm.10696.
- Individual participant dataSharing planned: Yes. De-identified data will be provided on request after discussion among parties.
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Healthy Adult Participants
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.
Marie-Pierre St-Onge, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Restriction (SR) in people with Sleep and Obesity, run by Columbia University 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 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: finished, as of the sponsor's last update on 3 Apr 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?
Yes. Results are posted in the registry (first posted 9 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Endpoint Fat Volume (time frame: Week 6 (endpoint)). 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 NCT02960776, which also lists 15 linked publications.
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 3 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.