Obesity
Conditions
Keywords
Bariatric surgery, Obesity, Weight loss maintenance
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.
Interventions
DEVICEWeighted 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.
Sponsors
University College Dublin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fat free mass retention | 1 year | Fat free mass retention as measured using DEXA scan |
| Weight loss | 1 year | Weight loss (kg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in protein and inflammatory markers IGF-1 | 1 year | Change in IGF-1 |
| Changes in protein and inflammatory marker levels myostatin | 1 year | Change in myostatin |
| Changes in protein and inflammatory markers | 1 year | Change in testosterone |
| Changes in protein and inflammatory markers IL-6 | 1 year | Change in IL-6 |
| Changes in protein and inflammatory markers lipocalin-2 | 1 year | Change in lipocalin-2 |
Countries
Ireland
Outcome results
None listed