Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05874726
Status:
SUSPENDED
Last Update Posted:
2023-08-07
First Post:
2023-03-31
Brief Title:
Biological Sample Repository for Gastrointestinal Disorders
Sponsor:
Pichamol Jirapinyo MD MPH
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Biological Sample Repository for Gastrointestinal Disorders
Status:
SUSPENDED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
IRB Approval Lapse - working on resubmission
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study has the purpose of collecting biological samples from obese patients undergoing evaluation for weight loss by means of medical or endoscopic therapies and of post bariatric surgery patients presenting with short- and long-term surgical complications The aim is to enhance the overall understanding of the mechanisms leading to obesity weight loss failure to lose weight and weight regain following treatment Additional goals are to determine the efficacy of endoscopic and surgical procedures to identify potential therapeutic targets and disease biomarkers that predict response to therapy
Detailed Description:
The prevalence of obesity in the US has reached unacceptably high numbers over the past three decades Approximately 68 of the American population over the age of 20 is overweight while 357 meet criteria for obesity CDC Obesity has become a leading cause of morbidity mortality and reduced quality of life and places patients at high risk for several chronic conditions including diabetes DM hypertension HTN hyperlipidemia HL sleep apnea GERD musculoskeletal disorders and cancer In addition obesity imposes a major burden in the American healthcare system with an estimated annual cost of 147 billion US dollars
Treatment of obesity is challenging Preventive measures and medical therapy have not been effective in fighting this epidemic Diet and exercise though logical are hindered by high recidivism and a propensity to regain weight to pre-weight loss levels Anti-obesity drugs are largely ineffective and limited by safety and side-effects profile Even bariatric surgery which provides significant and rapid weight loss is still followed by substantial weight regain over time In addition surgery is associated with a 1 mortality risk 5-25 1-year morbidity and is not readily accessible Fewer than 1 of eligible obese patients undergo surgery each year In face of all these challenges there is an urgent need to better understand the pathophysiology of obesity and the effects of current weight loss interventions This knowledge will provide a new framework for the development of more effective preventive measures and therapies
The pathophysiology of obesity is complex Weight gain results from an energy imbalance that is when energy intake is higher than expenditure In this context obesity has been attributed to a shift in diet toward increased consumption of energy-dense foods and to sedentary lifestyle However little is known about the physiological mechanisms underlying this trend which are thought to be regulated by genetic metabolic and neurobehavioral factors Even less is understood on how increased adiposity leads to the development of many metabolic disorders including DM Surprisingly these mechanisms can be reversed by bariatric procedures which in addition to weight loss have dramatic beneficial effects on metabolic disorders such as DM HTN and HL Therefore surgery has become an important study tool to enhance our understanding of the pathophysiology of obesity The collection of biological samples from patients before and after weight loss therapies including endoscopic and surgical procedures will provide the basis for a series of studies that will focus on investigating
the mechanisms that lead to obesity particularly appetite and gut regulatory peptides
the clinical physiological hormonal and metabolic changes imposed by medical surgical and endoscopic procedures to treat obesity
the mechanisms of weight regain following bariatric surgery
the mechanism of failure to lose weight following endoscopic or surgical procedures
the effects of endoscopic procedures on weight regain following bariatric surgery
biomarkers that predict response to medical endoscopic and surgical therapies
biomarkers that predict weight regain or therapeutic failures
novel therapeutic targets for the treatment of obesity
Medical therapies include weight loss diets or anti-obesity medications Bariatric endoscopic procedures include ablation techniques intragastric balloons submucosal tunneling procedures PSAM GEM G-POEM tissue plication platforms POSE ROSE endoluminal sleeves and endoscopic suturing devices ESG
Bariatric surgical procedures include laparoscopic adjustable gastric banding LAGB laparoscopic sleeve gastrectomy LSG Roux-en-Y gastric bypass RYGB bilio-pancreatic diversion BPD with or without duodenal switch BPD-DS
Treatment of obesity is challenging Preventive measures and medical therapy have not been effective in fighting this epidemic Diet and exercise though logical are hindered by high recidivism and a propensity to regain weight to pre-weight loss levels Anti-obesity drugs are largely ineffective and limited by safety and side-effects profile Even bariatric surgery which provides significant and rapid weight loss is still followed by substantial weight regain over time In addition surgery is associated with a 1 mortality risk 5-25 1-year morbidity and is not readily accessible Fewer than 1 of eligible obese patients undergo surgery each year In face of all these challenges there is an urgent need to better understand the pathophysiology of obesity and the effects of current weight loss interventions This knowledge will provide a new framework for the development of more effective preventive measures and therapies
The pathophysiology of obesity is complex Weight gain results from an energy imbalance that is when energy intake is higher than expenditure In this context obesity has been attributed to a shift in diet toward increased consumption of energy-dense foods and to sedentary lifestyle However little is known about the physiological mechanisms underlying this trend which are thought to be regulated by genetic metabolic and neurobehavioral factors Even less is understood on how increased adiposity leads to the development of many metabolic disorders including DM Surprisingly these mechanisms can be reversed by bariatric procedures which in addition to weight loss have dramatic beneficial effects on metabolic disorders such as DM HTN and HL Therefore surgery has become an important study tool to enhance our understanding of the pathophysiology of obesity The collection of biological samples from patients before and after weight loss therapies including endoscopic and surgical procedures will provide the basis for a series of studies that will focus on investigating
the mechanisms that lead to obesity particularly appetite and gut regulatory peptides
the clinical physiological hormonal and metabolic changes imposed by medical surgical and endoscopic procedures to treat obesity
the mechanisms of weight regain following bariatric surgery
the mechanism of failure to lose weight following endoscopic or surgical procedures
the effects of endoscopic procedures on weight regain following bariatric surgery
biomarkers that predict response to medical endoscopic and surgical therapies
biomarkers that predict weight regain or therapeutic failures
novel therapeutic targets for the treatment of obesity
Medical therapies include weight loss diets or anti-obesity medications Bariatric endoscopic procedures include ablation techniques intragastric balloons submucosal tunneling procedures PSAM GEM G-POEM tissue plication platforms POSE ROSE endoluminal sleeves and endoscopic suturing devices ESG
Bariatric surgical procedures include laparoscopic adjustable gastric banding LAGB laparoscopic sleeve gastrectomy LSG Roux-en-Y gastric bypass RYGB bilio-pancreatic diversion BPD with or without duodenal switch BPD-DS
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?:
None
Is an FDA AA801 Violation?:
None