Clinical trial NCT04809129: Testing the Gravitostat in Humans: the Impact of a Weighted Vest in Patients Post Bariatric Surgery on Fat-free Mass Retention and Weight Loss
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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Obesity
Keywords: Bariatric surgery
Obesity
Weight loss maintenance
Lead sponsor: University College Dublin
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Fat free mass retention
timeFrame: 1 year
measure: Weight loss
timeFrame: 1 year
Secondary outcomes:
measure: Changes in protein and inflammatory marker levels myostatin
timeFrame: 1 year
measure: Changes in protein and inflammatory markers lipocalin-2
timeFrame: 1 year
measure: Changes in protein and inflammatory markers IGF-1
timeFrame: 1 year
measure: Changes in protein and inflammatory markers IL-6
timeFrame: 1 year
measure: Changes in protein and inflammatory markers
timeFrame: 1 year
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: University College Dublin Clinical Research Centre
Study officials:
affiliation: University College Dublin
name: Carel W le Roux, PhD
role: PRINCIPAL_INVESTIGATOR
References: