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

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University College Dublin · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
DEVICE	Weighted vest	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.

Timeline

• Start date: 2021-04-08
• Primary completion: 2022-10-03
• Completion: 2022-10-03
• First posted: 2021-03-22
• Last updated: 2022-10-13

Locations

1 site across 1 country: Ireland