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

Primary Purpose

Obesity

Status
Suspended
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Weighted vest
Sponsored by
University College Dublin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Bariatric surgery, Obesity, Weight loss maintenance

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University College Dublin Clinical Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

External mechanical loading

Standard postoperative care

Arm Description

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%.

Patients following bariatric surgery (RYGB or SG) will receive standard postoperative care.

Outcomes

Primary Outcome Measures

Fat free mass retention
Fat free mass retention as measured using DEXA scan
Weight loss
Weight loss (kg)

Secondary Outcome Measures

Changes in protein and inflammatory marker levels myostatin
Change in myostatin
Changes in protein and inflammatory markers lipocalin-2
Change in lipocalin-2
Changes in protein and inflammatory markers IGF-1
Change in IGF-1
Changes in protein and inflammatory markers IL-6
Change in IL-6
Changes in protein and inflammatory markers
Change in testosterone

Full Information

First Posted
March 18, 2021
Last Updated
October 10, 2022
Sponsor
University College Dublin
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1. Study Identification

Unique Protocol Identification Number
NCT04809129
Brief 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
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Suspended
Why Stopped
Funding stopped.
Study Start Date
April 8, 2021 (Actual)
Primary Completion Date
October 3, 2022 (Anticipated)
Study Completion Date
October 3, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College Dublin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Bariatric surgery, Obesity, Weight loss maintenance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
External mechanical loading
Arm Type
Experimental
Arm Description
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%.
Arm Title
Standard postoperative care
Arm Type
No Intervention
Arm Description
Patients following bariatric surgery (RYGB or SG) will receive standard postoperative care.
Intervention Type
Device
Intervention Name(s)
Weighted vest
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fat free mass retention
Description
Fat free mass retention as measured using DEXA scan
Time Frame
1 year
Title
Weight loss
Description
Weight loss (kg)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Changes in protein and inflammatory marker levels myostatin
Description
Change in myostatin
Time Frame
1 year
Title
Changes in protein and inflammatory markers lipocalin-2
Description
Change in lipocalin-2
Time Frame
1 year
Title
Changes in protein and inflammatory markers IGF-1
Description
Change in IGF-1
Time Frame
1 year
Title
Changes in protein and inflammatory markers IL-6
Description
Change in IL-6
Time Frame
1 year
Title
Changes in protein and inflammatory markers
Description
Change in testosterone
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carel W le Roux, PhD
Organizational Affiliation
University College Dublin
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College Dublin Clinical Research Centre
City
Dublin
ZIP/Postal Code
Dublin 4
Country
Ireland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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