Trial Title:
Biological Sample Repository for Gastrointestinal Disorders
NCT ID:
NCT05874726
Condition:
Obesity
Obesity, Morbid
Obesity, Primary
Gastro-Intestinal Disorder
Overweight and Obesity
Overweight
Overweight or Obesity
Diabetes Type 2
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Hyperlipidemias
Sleep Apnea
GERD
Gastroesophageal Reflux
Musculoskeletal Pain Disorder
Cancer
Conditions: Official terms:
Musculoskeletal Pain
Rheumatic Diseases
Gastroesophageal Reflux
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Collagen Diseases
Diabetes Mellitus
Obesity
Overweight
Diabetes Mellitus, Type 2
Hyperlipidemias
Obesity, Morbid
Somatoform Disorders
Conditions: Keywords:
Gut Hormones
Bariatric Surgery
Weight Loss
Weight Loss Diets
Anti-obesity Medications
Endoscopic Metabolic and Bariatric Therapies (EMBT)
Bariatric Endoscopy
Intragastric balloon (IGB)
Ablation Techniques
Submucosal Tunneling Procedures
pylorus sparing antral myotomy (PSAM)
gastroplasty with endoscopic myotomy (GEM)
Gastric peroral endoscopic myotomy (G-POEM)
Tissue Plication
Primary Obesity Surgery Endolumenal (POSE)
Restorative Obesity Surgery Endoluminal (ROSE)
Endoluminal sleeves
Endoscopic Suturing
Endoscopic Sleeve Gastroplasty (ESG)
laparoscopic adjustable gastric banding (LAGB)
laparoscopic sleeve gastrectomy (LSG)
Roux-en-Y gastric bypass (RYGB)
bilio-pancreatic diversion (BPD)
bilio-pancreatic diversion with duodenal switch (BPD-DS)
Pathophysiology of obesity
Study type:
Observational [Patient Registry]
Overall status:
Suspended
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Blood Collection
Description:
Blood collection via venipuncture
Arm group label:
Bariatric Surgery Patients
Arm group label:
Endoscopic Metabolic and Bariatric Therapies
Arm group label:
Medical Management
Intervention type:
Diagnostic Test
Intervention name:
Urine Collection
Description:
Free catch urine sample collection
Arm group label:
Bariatric Surgery Patients
Arm group label:
Endoscopic Metabolic and Bariatric Therapies
Arm group label:
Medical Management
Intervention type:
Diagnostic Test
Intervention name:
Tissue Sample Collection
Description:
Tissue (gastric, duodenum, jejunum and ileum - number of biopsies will be 3-4 from each
site, ranging in size from 4-7mm) - These samples collected will be extra biopsies that
are taken for research purposes during a clinically planned endoscopy for which biopsies
are being planned.
Arm group label:
Bariatric Surgery Patients
Arm group label:
Endoscopic Metabolic and Bariatric Therapies
Arm group label:
Medical Management
Other name:
Biopsy
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 U.S. has reached unacceptably high numbers over the past
three decades. Approximately 68% of the American population over the age of 20 is
overweight, while 35.7% 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 U.S. 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).
Criteria for eligibility:
Study pop:
The purpose of this repository is to study obesity, as well as the effects of weight loss
therapies on several clinical, physiological, hormonal and biochemical parameters.
Therefore, enrollment in this repository will be limited to patients with obesity
undergoing evaluation for weight loss through medical, endoscopic or surgical means.
Obesity is a condition that affects all ethnic and racial groups. Investigators do not
anticipate that any particular group of patients will be disproportionately represented.
Although obesity affects both children and adults, this repository will be limited to
adult patients, which represent the practices of the physicians involved in this
protocol.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Be older than 18 years of age,
- Suffer from obesity, defined by BMI≥30 kg/m2 (body mass index: weight in kilograms
divided by the square of the height in meters).
Exclusion Criteria:
- Positive laboratory tests for any of the following pathogens: Hepatitis B virus
(HBV); Hepatitis C virus (HCV); Human Immunodeficiency Virus Types 1 and 2 (HIV);
Human T-Lymphotropic virus Types I and II (HTLV); Treponema pallidum (syphilis);
Clostridium Difficile (C. Diff)
- History of gastrointestinal malabsorptive disorders including a known history of
celiac disease, and/or chronic pancreatitis,
- History of any inflammatory disease of the gastrointestinal tract,
- Patient is of childbearing age and not practicing effective birth control method,
pregnant or lactating
- History of a myocardial infarction or cerebro-vascular accident in the last year, or
history of unstable cardiovascular disease,
- History of cancer or life expectancy of < 2 yrs,
- Use of any medications (prescription or OTC), including herbal or other supplements
for treatment of obesity,
- History of known hormonal or genetic cause for obesity,
- History of any psychiatric disorders including dementia, active psychosis, severe
depression requiring > 2 medications, history of suicide attempts, alcohol or drug
abuse within the previous 12 months,
- Any condition or major illness that, in the investigator's judgment, places the
subject at undue risk of participating in the repository,
- Unable to understand the risks, realistic benefits and requirements of the
repository,
- Use of investigational therapy or participation in any other clinical trial within
12 weeks prior to signing the ICF.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Brigham and Women's Hospital
Address:
City:
Boston
Zip:
02115
Country:
United States
Start date:
July 19, 2023
Completion date:
April 2029
Lead sponsor:
Agency:
Pichamol Jirapinyo, MD, MPH
Agency class:
Other
Collaborator:
Agency:
Tufts University
Agency class:
Other
Collaborator:
Agency:
Boston Children's Hospital
Agency class:
Other
Collaborator:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Brigham and Women's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05874726
