AzTrials
AzTrials

ObesityNCT05874726

Biological Sample Repository for Gastrointestinal Disorders

An observational study of Obesity and Obesity, Morbid, run by Pichamol Jirapinyo, MD, MPH at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Obesity, Morbid, Obesity, Primary
What is being tested?
Blood Collection, Urine Collection and Tissue Sample Collection
How many people
500 participants
Where
1 siteUnited States
Study dates
19 Jul 2023to Apr 2029
How long will I take part?
10 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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).

Who cannot join

  • 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,
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

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.

Read the 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).

Being tested
Blood Collection, Urine Collection, Tissue Sample Collection
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)
Medical subject headings
Obesity, Obesity, Morbid, Digestive System Diseases, Overweight, Diabetes Mellitus, Type 2, Diabetes Mellitus, Hypertension, Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood CollectionDiagnostic test

    Blood collection via venipuncture

  • Urine CollectionDiagnostic test

    Free catch urine sample collection

  • Tissue Sample CollectionDiagnostic test

    Also called Biopsy

    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.

Study groups in NCT05874726
Study groupRoleWhat they receive
Bariatric Surgery PatientsSubjects 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).
Receives: Diagnostic Test: Blood Collection; Diagnostic Test: Urine Collection; Diagnostic Test: Tissue Sample Collection
Endoscopic Metabolic and Bariatric TherapiesSubjects 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).
Receives: Diagnostic Test: Blood Collection; Diagnostic Test: Urine Collection; Diagnostic Test: Tissue Sample Collection
Medical ManagementSubjects 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.
Receives: Diagnostic Test: Blood Collection; Diagnostic Test: Urine Collection; Diagnostic Test: Tissue Sample Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from Baseline to 10 years.

  2. Urine sample repository

    Urine (5 ml) will be collected via free catch method and stored at -80 degrees C for up to 10 years.

    Measured: Change from Baseline to 10 years.

  3. 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.

    Measured: Change from Baseline to 10 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2023
  2. Study start19 Jul 2023
  3. Primary completionJul 2028 (estimated)
  4. Study completionApr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
500 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05874726
Sponsor's protocol ID
2022P003060
Status last verified
Nov 2025
First submitted
31 Mar 2023
Last updated
2 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 17498505

  • Finkelstein 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.

    PubMed 19635784

  • Anderson 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.

    PubMed 11684524

  • Powell 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.

    PubMed 21654742

  • Sjostrom 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.

    PubMed 15616203

  • Sjostrom 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.

    PubMed 17715408

  • Dixon 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.

    PubMed 23219371

  • Guyenet 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.

    PubMed 22238401

  • Buchwald 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.

    PubMed 15479938

  • Buchwald H, Oien DM. Metabolic/bariatric surgery Worldwide 2008. Obes Surg. 2009 Dec;19(12):1605-11. doi: 10.1007/s11695-009-0014-5.

    PubMed 19885707

  • Buchwald 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.

    PubMed 19272486

  • Perdomo 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.

    PubMed 36774932

  • Qureshi 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.

    PubMed 36769774

  • Jirapinyo 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.

    PubMed 35348970

  • Dolan 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.

    PubMed 34554827

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Obesity, Morbid, run by Pichamol Jirapinyo, MD, MPH at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum sample repository (time frame: Change from Baseline to 10 years.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05874726, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT05874726 | AzTrials