Biological Sample Repository for Gastrointestinal Disorders

November 25, 2025 updated by: Pichamol Jirapinyo, MD, MPH
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bariatric Surgery Patients
Subjects who have had bariatric surgery for obesity - primary and revision. 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).
Diagnostic test: Blood Collection
Blood collection via venipuncture
Diagnostic test: Urine Collection
Free catch urine sample collection
Diagnostic test: Tissue Sample Collection
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.
Other Names:
  • Biopsy
Endoscopic Metabolic and Bariatric Therapies
Subjects who have had endoscopic bariatric therapies for obesity - primary and revision. 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).
Diagnostic test: Blood Collection
Blood collection via venipuncture
Diagnostic test: Urine Collection
Free catch urine sample collection
Diagnostic test: Tissue Sample Collection
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.
Other Names:
  • Biopsy
Medical Management
Subjects who follow lifestyle modification and/or anti-obesity medications for treatment of obesity with no previous surgical intervention for obesity. Medical therapies include weight loss diets or anti-obesity medications.
Diagnostic test: Blood Collection
Blood collection via venipuncture
Diagnostic test: Urine Collection
Free catch urine sample collection
Diagnostic test: Tissue Sample Collection
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.
Other Names:
  • Biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum sample repository
Time Frame: Change 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.
Change from Baseline to 10 years.
Urine sample repository
Time Frame: Change 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.
Change from Baseline to 10 years.
Tissue sample repository
Time Frame: Change 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.
Change from Baseline to 10 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pichamol Jirapinyo, MD, MPH

Collaborators

Mayo Clinic
Tufts University
Boston Children's Hospital

Investigators

  • Principal Investigator: Pichamol Jirapinyo, MD, MPH, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

July 19, 2023

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

March 31, 2023

First Submitted That Met QC Criteria

May 23, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022P003060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

MGB and non-MGB investigators may request samples (any of the samples listed in this protocol) from this tissue repository. This request will be made after establishing a formal collaboration with investigators in this protocol. Requests will be made in the form of a written document stating the title and purpose of the project, as well as which experimental procedures will be done with the repository samples. In addition to a written request, collaborators will have to share their approved IRB protocol with the investigators in this repository.

IPD Sharing Time Frame

12 months after publication

IPD Sharing Access Criteria

Requests will be overseen by Michele Ryan, the research coordinator and laboratory manager. Requests will be reviewed by the PI, and approved based on her judgment and the lack of conflicts with the PI's current research studies.

Michele Ryan and Dr. Jirapinyo will assess all tissue requests and ensure a current, IRB-approved protocol is in place covering the proposed research.

For non-MGB investigators that are not part of the study team, tissue will only be distributed that is coded, but not directly identifiable. Investigators will not allow the recipient researcher to identify the individual from whom the tissue was obtained. Investigators will have the recipient researcher agree in writing never to attempt to access identifiable health/medical information or to attempt to identify and contact the individual(s) who have provided the samples.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on Blood Collection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe