Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06274606
Status:
WITHDRAWN
Last Update Posted:
2024-06-14
First Post:
2024-01-18
Brief Title:
Exercise Training Study Before Bariatric Surgery
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Exercise Training Study Before Bariatric Surgery
Status:
WITHDRAWN
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Project during development was discontinued before the enrollment of participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BaSE
Brief Summary:
The goal of this clinical trial is to figure out if 8 weeks of walking exercise before bariatric surgery improves risk factors for diabetes and other markers of health This is important as it may help reduce complications after surgery improve health markers and increase physical activity levels after surgery which is an important marker of maintaining bariatric weight loss The main question that this study is trying to answer is whether walking improves a risk factor for type 2 diabetes called insulin sensitivity how well your body is able to use glucose
Adults planning to have bariatric surgery will be recruited from the Charlottesville VA area Before they have their surgery participants will be randomly assigned like flipping a coin to a group that participates in 8 weeks of walking on a treadmill 2-3 times a week or a group that does their normal care before bariatric surgery
Researchers will compare the effects of walking before bariatric surgery on
Insulin sensitivity diabetes risk factor
Health of blood vessels
Rate of complications after surgery
Weight
Body Fat
Fitness level
Adults planning to have bariatric surgery will be recruited from the Charlottesville VA area Before they have their surgery participants will be randomly assigned like flipping a coin to a group that participates in 8 weeks of walking on a treadmill 2-3 times a week or a group that does their normal care before bariatric surgery
Researchers will compare the effects of walking before bariatric surgery on
Insulin sensitivity diabetes risk factor
Health of blood vessels
Rate of complications after surgery
Weight
Body Fat
Fitness level
Detailed Description:
The purpose of the present study is to evaluate the impact of 8 weeks of supervised aerobic exercise prior to bariatric surgery on insulin sensitivity using the hyperinsulinemic-euglycemic clamp Participants will be recruited from the area surrounding the UVA hospital while the primary outcome will be insulin sensitivity as measured by the hyperinsulinemic-euglycemic clamp procedure and secondary outcomes include the effects of the exercise intervention on surgical outcomes and cardiometabolic and arterial health in bariatric patients
Objectives
Primary Objective To investigate the effects of exercise standard care and standard care only in obese individuals prior to bariatric surgery on insulin sensitivity after bariatric surgery
Secondary Objectives To examine the effects of exercise standard care and standard care only in obese individuals prior to bariatric surgery on surgical outcomes such as length of stay post-surgery and other clinically relevant outcomes such as cardiometabolic and arterial health in adults following bariatric surgery
Hypotheses
Primary Hypothesis An 8-week exercise intervention before bariatric surgery will improve insulin sensitivity as measured by the hyperinsulinemic-euglycemic clamp following bariatric surgery
Secondary Hypothesis An 8-week exercise intervention will improve clinically relevant post-surgical outcomes such as surgical outcomes quality of life arterial health and other cardiometabolic factors following bariatric surgery
Objectives
Primary Objective To investigate the effects of exercise standard care and standard care only in obese individuals prior to bariatric surgery on insulin sensitivity after bariatric surgery
Secondary Objectives To examine the effects of exercise standard care and standard care only in obese individuals prior to bariatric surgery on surgical outcomes such as length of stay post-surgery and other clinically relevant outcomes such as cardiometabolic and arterial health in adults following bariatric surgery
Hypotheses
Primary Hypothesis An 8-week exercise intervention before bariatric surgery will improve insulin sensitivity as measured by the hyperinsulinemic-euglycemic clamp following bariatric surgery
Secondary Hypothesis An 8-week exercise intervention will improve clinically relevant post-surgical outcomes such as surgical outcomes quality of life arterial health and other cardiometabolic factors following bariatric surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None