Biological Sample Repository for Gastrointestinal Disorders
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.
Conditions:
🦠 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
🗓️ Study Start (Actual) 19 July 2023
🗓️ Primary Completion (Estimated) July 2028
✅ Study Completion (Estimated) April 2029
👥 Enrollment (Estimated) 500
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 31 March 2023
  • First Submitted that Met QC Criteria 23 May 2023
  • First Posted 25 May 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 4 August 2023
  • Last Update Posted 7 August 2023
  • Last Verified August 2023