Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
Study NCT ID:
NCT06576050
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-09-04
First Post:
2024-08-26
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
WeighT LOSS Surgery and Comprehensive Cardiometabolic Responses to to EXercise
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
A Prospective Evaluation of Subjects Undergoing Weight Loss Surgery to Determine Cardiometabolic Responses to Exercise
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WTLOSS-EX
Brief Summary:
The goal of this study is to define how treatment of obesity impacts cardiometabolic performance during exercise in patients with established HFpEF or at risk for HFpEF. Multi-dimensional physical activity, including 6 minute walk distance, resting metabolic rate, the metabolic cost of initiating exercise, and low-level, intermediate, peak exercise, and recovery oxygen utilization patterns will be examined in relation to weight loss in people having bariatric surgery. The investigators also aim to learn more about the relationship between obesity, exercise intolerance, and heart failure with preserved ejection fraction (HFpEF). The investigators are interested in the extent to which HFpEF\'s manifestations are preventable or reversible with weight-loss interventions. The main questions it aims to answer are:
1. How does weight loss surgery affect comprehensive measures of physical activity?
2. What are the biochemical signatures of obesity and their reversibility in patients with HFpEF and obesity?
1. How does weight loss surgery affect comprehensive measures of physical activity?
2. What are the biochemical signatures of obesity and their reversibility in patients with HFpEF and obesity?
Detailed Description:
A prospective evaluation of subjects with HFpEF or at risk for HFpEF undergoing laparoscopic sleeve gastrectomy surgery to determine cardiometabolic responses to exercise.
The investigators will prospectively evaluate twenty-one patients to determine cardiometabolic responses to exercise before and 12-months after bariatric surgery. The investigators will map pulmonary/pulmonary vascular function, ventilatory efficiency (VE/VCO2 slope); left ventricular-systemic vascular function (based on echo measures) as well as exercise blood pressure responses (SBP at 30 Watts); sympathetic nervous system function during exercise will be assessed by heart rate-O2 pulse relationships; peripheral abnormalities characteristic of HFpEF will be measured by assessment of O2 kinetics during exercise onset and recovery. Additionally, global metabolic reserve will be captured by assessment of peak VO2. The comprehensive evaluation of these patients pre- and post-weight loss will further elucidate relationships between HFpEF and obesity, and their plasticity in response to weight loss, while also setting the stage to evaluate clinical trial endpoints that influence how patients function and feel (e.g. CPET-derived exercise capacity). The investigators will also assess exercise capacity and additional markers of metabolic health.
The investigators will prospectively evaluate twenty-one patients to determine cardiometabolic responses to exercise before and 12-months after bariatric surgery. The investigators will map pulmonary/pulmonary vascular function, ventilatory efficiency (VE/VCO2 slope); left ventricular-systemic vascular function (based on echo measures) as well as exercise blood pressure responses (SBP at 30 Watts); sympathetic nervous system function during exercise will be assessed by heart rate-O2 pulse relationships; peripheral abnormalities characteristic of HFpEF will be measured by assessment of O2 kinetics during exercise onset and recovery. Additionally, global metabolic reserve will be captured by assessment of peak VO2. The comprehensive evaluation of these patients pre- and post-weight loss will further elucidate relationships between HFpEF and obesity, and their plasticity in response to weight loss, while also setting the stage to evaluate clinical trial endpoints that influence how patients function and feel (e.g. CPET-derived exercise capacity). The investigators will also assess exercise capacity and additional markers of metabolic health.
Study Oversight
Has Oversight DMC:
False
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?:
None
Is an FDA AA801 Violation?: