Testing the Gravitostat in Humans: the Impact of a Weighted Vest in Patients Post Bariatric Surgery on Fat-free Mass Retention and Weight Loss

Obesity Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04809129
• Other study ID #: RS20-012
• Status: Suspended
• Phase: N/A
• Start date: April 8, 2021
• Est. completion date: October 3, 2022

Study information

• Verified date: October 2022
• Source: University College Dublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. completion date: October 3, 2022
• Est. primary completion date: October 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
Ireland	University College Dublin Clinical Research Centre	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
University College Dublin

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fat free mass retention	Fat free mass retention as measured using DEXA scan	1 year
Primary	Weight loss	Weight loss (kg)	1 year
Secondary	Changes in protein and inflammatory marker levels myostatin	Change in myostatin	1 year
Secondary	Changes in protein and inflammatory markers lipocalin-2	Change in lipocalin-2	1 year
Secondary	Changes in protein and inflammatory markers IGF-1	Change in IGF-1	1 year
Secondary	Changes in protein and inflammatory markers IL-6	Change in IL-6	1 year
Secondary	Changes in protein and inflammatory markers	Change in testosterone	1 year