ObesityNCT04809129
Testing the Gravitostat in Humans: the Impact of a Weighted Vest in Patients Post Bariatric Surgery on Fat-free Mass Retention and Weight Loss
A study testing Weighted vest in people with Obesity, run by University College Dublin at 1 site in Ireland.
Trial summary
The mechanisms regulating fat mass homeostasis are incompletely understood although recent animal and human trials would suggest that there is a leptin independent regulatory pathway which may play a role in weight control and maintenance. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Weighted vest
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIreland
- Study dates
- 8 Apr 2021to 3 Oct 2022
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Undergoing bariatric surgery- Roux en Y gastric bypass or sleeve gastrectomy
- Age 18-60
- BMI >30kg/m2
- Reporting regular physical exercise (>3 days/week)
- Willingness to comply with the study protocol
Who cannot join
- Sedentary lifestyle
- Chronic pain that is constant and impairs the quality of life such as severe back, hip or knee pain
- Reduced mobility requiring the use of a mobility aid
- Undergoing revisional surgery
- Concerns from the investigator that the participant will be unable to fully comply with the study protocol
Trial locations and contacts
1 site in 1 country.
Ireland1 site
University College Dublin Clinical Research Centre
Dublin, Dublin 4
About this study
The mechanisms regulating fat mass homeostasis are incompletely understood although recent animal and human trials would suggest that there is a leptin independent regulatory pathway which may play a role in weight control and maintenance. Although evidence would suggest that external loading in patients with obesity may promote body weight loss, this has not been explored in patients following bariatric surgery.
The aim of this study is to investigate the mechanisms regulating weight loss and the potential role of the 'gravitostat' in fat free mass retention in patients following bariatric surgery.
Read the detailed description
The aim of the study is to investigate the mechanisms that regulate weight loss, particularly following bariatric surgery. Previous animal studies have suggested that there is an underlying regulatory process controlled by 'the gravitostat' which is an evolutionary adaptation responsible for weight control and maintenance. Studies exploring this concept in rodent models have suggested that artificially increasing the animal's weight with the implantation of weighted capsules results in greater weight loss in mice with obesity but does not affect those of normal weight. We will use weighted vests in patients following surgery to replicate this increased mechanical loading to determine whether a similar process occurs in humans. This will improve our understanding of the underlying processes regulating weight in patients with obesity and following bariatric surgery.
- Conditions
- Obesity
- Being tested
- Weighted vest
- Keywords
- Bariatric surgery, Obesity, Weight loss maintenance
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weighted vestDevice
Patients will wear a weighted vest following bariatric surgery with weight increased incrementally to maintain baseline weight. This vest will be worn for a minimum of 8 hours a day for three months postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| External mechanical loading | Experimental | Following bariatric surgery (RYGB or SG) patients will be asked to wear a weighted vest for a minimum of 8 hours daily and during physical exercise for three months postoperatively.
Weight will be incrementally added on a weekly basis to maintain the baseline weight as patients lose weight following surgery up to a maximum of 15%. Receives: Device: Weighted vest |
| Standard postoperative care | No intervention | Patients following bariatric surgery (RYGB or SG) will receive standard postoperative care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat free mass retention
Fat free mass retention as measured using DEXA scan
Measured: 1 year
Weight loss
Weight loss (kg)
Measured: 1 year
Secondary outcomes (5)
Changes in protein and inflammatory marker levels myostatin
Change in myostatin
Measured: 1 year
Changes in protein and inflammatory markers lipocalin-2
Change in lipocalin-2
Measured: 1 year
Changes in protein and inflammatory markers IGF-1
Change in IGF-1
Measured: 1 year
Changes in protein and inflammatory markers IL-6
Change in IL-6
Measured: 1 year
Changes in protein and inflammatory markers
Change in testosterone
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start8 Apr 2021
- Primary completion3 Oct 2022 (estimated)
- Study completion3 Oct 2022 (estimated)
Why it stopped: Funding stopped.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carel W le Roux, PhD, Principal investigator, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809129
- Sponsor's protocol ID
- RS20-012
- Status last verified
- Oct 2022
- First submitted
- 18 Mar 2021
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Gravitostat in Humans: the Impact of a Weighted Vest in Patients Post Bariatric Surgery on Fat-free Mass Retention and Weight Loss
- ClinicalTrials.gov ID
- NCT04809129
- Acronym / sponsor ID
- RS20-012
- Conditions
- Obesity
- Keywords
- Bariatric surgery, Obesity, Weight loss maintenance
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Funding stopped.
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 3 Oct 2022 (estimated)
- Study completion
- 3 Oct 2022 (estimated)
- First posted
- 22 Mar 2021 (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.
The mechanisms regulating fat mass homeostasis are incompletely understood although recent animal and human trials would suggest that there is a leptin independent regulatory pathway which may play a role in weight control and maintenance. Although evidence would suggest that external loading in patients with obesity may promote body weight loss, this has not been explored in patients following bariatric surgery.
The aim of this study is to investigate the mechanisms regulating weight loss and the potential role of the 'gravitostat' in fat free mass retention in patients following bariatric surgery.
Detailed description
The aim of the study is to investigate the mechanisms that regulate weight loss, particularly following bariatric surgery. Previous animal studies have suggested that there is an underlying regulatory process controlled by 'the gravitostat' which is an evolutionary adaptation responsible for weight control and maintenance. Studies exploring this concept in rodent models have suggested that artificially increasing the animal's weight with the implantation of weighted capsules results in greater weight loss in mice with obesity but does not affect those of normal weight. We will use weighted vests in patients following surgery to replicate this increased mechanical loading to determine whether a similar process occurs in humans. This will improve our understanding of the underlying processes regulating weight in patients with obesity and following bariatric surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External mechanical loading | Experimental | Device: Weighted vestFollowing bariatric surgery (RYGB or SG) patients will be asked to wear a weighted vest for a minimum of 8 hours daily and during physical exercise for three months postoperatively. Weight will be incrementally added on a weekly basis to maintain the baseline weight as patients lose weight following surgery up to a maximum of 15%. |
| Standard postoperative care | No intervention | –Patients following bariatric surgery (RYGB or SG) will receive standard postoperative care. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Undergoing bariatric surgery- Roux en Y gastric bypass or sleeve gastrectomy
- Age 18-60
- BMI >30kg/m2
- Reporting regular physical exercise (>3 days/week)
- Willingness to comply with the study protocol
Key exclusion criteria (5 listed)
- Sedentary lifestyle
- Chronic pain that is constant and impairs the quality of life such as severe back, hip or knee pain
- Reduced mobility requiring the use of a mobility aid
- Undergoing revisional surgery
- Concerns from the investigator that the participant will be unable to fully comply with the study protocol
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 |
|---|---|---|
| Weighted vestPatients will wear a weighted vest following bariatric surgery with weight increased incrementally to maintain baseline weight. This vest will be worn for a minimum of 8 hours a day for three months postoperatively. | Device | External mechanical loading |
Primary outcome
Fat free mass retention
Time frame: 1 year
Fat free mass retention as measured using DEXA scan
Weight loss
Time frame: 1 year
Weight loss (kg)
5 secondary outcomes
Changes in protein and inflammatory marker levels myostatin
Time frame: 1 year
Changes in protein and inflammatory markers lipocalin-2
Time frame: 1 year
Changes in protein and inflammatory markers IGF-1
Time frame: 1 year
Changes in protein and inflammatory markers IL-6
Time frame: 1 year
Changes in protein and inflammatory markers
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- 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.
Carel W le Roux, PhD principal investigator
University College Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weighted vest in people with Obesity, run by University College Dublin at 1 site in Ireland.
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 5 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: paused, as of the sponsor's last update on 13 Oct 2022. 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 Ireland. 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?
Results are not available in the source record.
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?
Fat free mass retention (time frame: 1 year). 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?
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 Oct 2022.