Active, not recruitingNot applicableObservational
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionObesity, 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
Full registry 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.
Treatments and study arms
Blood Collection
Diagnostic Test
Blood collection via venipuncture
Urine Collection
Diagnostic Test
Free catch urine sample collection
Tissue Sample Collection
Diagnostic Test
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.
Primary outcomes
Serum sample repositoryChange from Baseline to 10 years.Blood (10 ml) will be collected from the enrolled subjects, serum will be extracted and stored at -80 degrees for up to 10 years.
Urine sample repositoryChange from Baseline to 10 years.Urine (5 ml) will be collected via free catch method and stored at -80 degrees C for up to 10 years.
Tissue sample repositoryChange from Baseline to 10 years.Tissue samples (gastric, duodenum, jejunum and ileum - number of biopsies will be 3-4 from each site, ranging in size from 4-7mm) will be collected during a scheduled endoscopic examination. Biopsy tissue will be collected with a large capacity biopsy forceps and deposited into a conical vial containing a freshly prepared balanced salt solution including a HEPES buffer at the bedside, using 5mL of buffered salt solution per 5-10 mm3 of tissue biopsy, at 4 degrees C. Tissue will be stored at -80⁰C until they are "used up" or for up to 10 years from collection.
