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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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%. |
|
| Standard postoperative care | No Intervention | Patients following bariatric surgery (RYGB or SG) will receive standard postoperative care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weighted vest | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fat free mass retention | Fat free mass retention as measured using DEXA scan | 1 year |
| Weight loss | Weight loss (kg) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in protein and inflammatory marker levels myostatin | Change in myostatin | 1 year |
| Changes in protein and inflammatory markers lipocalin-2 | Change in lipocalin-2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carel W le Roux, PhD | University College Dublin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College Dublin Clinical Research Centre | Dublin | Dublin 4 | Ireland |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 1 year |
| Changes in protein and inflammatory markers IGF-1 | Change in IGF-1 | 1 year |
| Changes in protein and inflammatory markers IL-6 | Change in IL-6 | 1 year |
| Changes in protein and inflammatory markers | Change in testosterone | 1 year |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |