Biological Sample Repository for Gastrointestinal Disorders
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2023
CompletedFirst Posted
Study publicly available on registry
May 25, 2023
CompletedStudy Start
First participant enrolled
July 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
December 2, 2025
November 1, 2025
5 years
March 31, 2023
November 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Serum sample repository
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
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
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.
Study Arms (3)
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).
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).
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.
Interventions
Blood collection via venipuncture
Free catch urine 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.
Eligibility Criteria
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.
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pichamol Jirapinyo, MD, MPHlead
- Tufts Universitycollaborator
- Boston Children's Hospitalcollaborator
- Mayo Cliniccollaborator
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Related Publications (15)
Ogden CL, Yanovski SZ, Carroll MD, Flegal KM. The epidemiology of obesity. Gastroenterology. 2007 May;132(6):2087-102. doi: 10.1053/j.gastro.2007.03.052.
PMID: 17498505BACKGROUNDFinkelstein EA, Trogdon JG, Cohen JW, Dietz W. Annual medical spending attributable to obesity: payer-and service-specific estimates. Health Aff (Millwood). 2009 Sep-Oct;28(5):w822-31. doi: 10.1377/hlthaff.28.5.w822. Epub 2009 Jul 27.
PMID: 19635784BACKGROUNDAnderson JW, Konz EC, Frederich RC, Wood CL. Long-term weight-loss maintenance: a meta-analysis of US studies. Am J Clin Nutr. 2001 Nov;74(5):579-84. doi: 10.1093/ajcn/74.5.579.
PMID: 11684524BACKGROUNDPowell AG, Apovian CM, Aronne LJ. New drug targets for the treatment of obesity. Clin Pharmacol Ther. 2011 Jul;90(1):40-51. doi: 10.1038/clpt.2011.82. Epub 2011 Jun 8.
PMID: 21654742BACKGROUNDSjostrom L, Lindroos AK, Peltonen M, Torgerson J, Bouchard C, Carlsson B, Dahlgren S, Larsson B, Narbro K, Sjostrom CD, Sullivan M, Wedel H; Swedish Obese Subjects Study Scientific Group. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004 Dec 23;351(26):2683-93. doi: 10.1056/NEJMoa035622.
PMID: 15616203BACKGROUNDSjostrom L, Narbro K, Sjostrom CD, Karason K, Larsson B, Wedel H, Lystig T, Sullivan M, Bouchard C, Carlsson B, Bengtsson C, Dahlgren S, Gummesson A, Jacobson P, Karlsson J, Lindroos AK, Lonroth H, Naslund I, Olbers T, Stenlof K, Torgerson J, Agren G, Carlsson LM; Swedish Obese Subjects Study. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med. 2007 Aug 23;357(8):741-52. doi: 10.1056/NEJMoa066254.
PMID: 17715408BACKGROUNDDixon JB, Lambert GW. The obesity paradox--a reality that requires explanation and clinical interpretation. Atherosclerosis. 2013 Jan;226(1):47-8. doi: 10.1016/j.atherosclerosis.2012.11.005. Epub 2012 Nov 15. No abstract available.
PMID: 23219371BACKGROUNDGuyenet SJ, Schwartz MW. Clinical review: Regulation of food intake, energy balance, and body fat mass: implications for the pathogenesis and treatment of obesity. J Clin Endocrinol Metab. 2012 Mar;97(3):745-55. doi: 10.1210/jc.2011-2525. Epub 2012 Jan 11.
PMID: 22238401BACKGROUNDBuchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724.
PMID: 15479938BACKGROUNDBuchwald H, Oien DM. Metabolic/bariatric surgery Worldwide 2008. Obes Surg. 2009 Dec;19(12):1605-11. doi: 10.1007/s11695-009-0014-5.
PMID: 19885707BACKGROUNDBuchwald H, Estok R, Fahrbach K, Banel D, Jensen MD, Pories WJ, Bantle JP, Sledge I. Weight and type 2 diabetes after bariatric surgery: systematic review and meta-analysis. Am J Med. 2009 Mar;122(3):248-256.e5. doi: 10.1016/j.amjmed.2008.09.041.
PMID: 19272486BACKGROUNDPerdomo CM, Cohen RV, Sumithran P, Clement K, Fruhbeck G. Contemporary medical, device, and surgical therapies for obesity in adults. Lancet. 2023 Apr 1;401(10382):1116-1130. doi: 10.1016/S0140-6736(22)02403-5. Epub 2023 Feb 9.
PMID: 36774932BACKGROUNDQureshi H, Saeed N, Jovani M. Updates in Endoscopic Bariatric and Metabolic Therapies. J Clin Med. 2023 Jan 31;12(3):1126. doi: 10.3390/jcm12031126.
PMID: 36769774BACKGROUNDJirapinyo P, Thompson CC. Primary Bariatric Procedures. Dig Dis Sci. 2022 May;67(5):1674-1687. doi: 10.1007/s10620-022-07393-z. Epub 2022 Mar 29.
PMID: 35348970BACKGROUNDDolan RD, Schulman AR. Endoscopic Approaches to Obesity Management. Annu Rev Med. 2022 Jan 27;73:423-438. doi: 10.1146/annurev-med-042320-125832. Epub 2021 Sep 23.
PMID: 34554827BACKGROUND
Biospecimen
* Blood (serum will be extracted and stored at -80⁰C), * Urine (stored at -80⁰C), * 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. * Data from medical records will be collected including: age, gender, vitals, weight, bmi, graphs, medical history, surgical history, endoscopy reports, radiology reports, labs, demographics, medications, problem list. Investigators do plan to continue collecting data into the future.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pichamol Jirapinyo, MD, MPH
Brigham and Women's Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Director of Bariatric Endoscopy
Study Record Dates
First Submitted
March 31, 2023
First Posted
May 25, 2023
Study Start
July 19, 2023
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
April 1, 2029
Last Updated
December 2, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 12 months after publication
- 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.
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.