Clinical trial · Observational
Biological Sample Repository for Gastrointestinal Disorders
NCT05874726CI-TRIAL-00098157active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (17)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Diabetes Mellitus | — | UNRESOLVED | — |
| Diabetes Mellitus, Type 2 | — | UNRESOLVED | — |
| Diabetes Type 2 | — | UNRESOLVED | — |
| Gastroesophageal Reflux | — | UNRESOLVED | — |
| Gastro-Intestinal Disorder | — | UNRESOLVED | — |
| GERD | — | UNRESOLVED | — |
| Hyperlipidemias | — | UNRESOLVED | — |
| Hypertension | — | UNRESOLVED | — |
| Musculoskeletal Pain Disorder | — | UNRESOLVED | — |
| Obesity | — | UNRESOLVED |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Collection | Diagnostic Test | — | UNRESOLVED |
| Tissue Sample Collection | Diagnostic Test | — | UNRESOLVED |
| Urine Collection | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Bariatric Surgery Patients
- description
- 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).
- interventionNames
- Diagnostic Test: Blood Collection
- Diagnostic Test: Urine Collection
- Diagnostic Test: Tissue Sample Collection
- label
- Endoscopic Metabolic and Bariatric Therapies
- description
- 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).
- interventionNames
- Diagnostic Test: Blood Collection
- Diagnostic Test: Urine Collection
- Diagnostic Test: Tissue Sample Collection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (15)
- BACKGROUNDOgden 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 17498505
- BACKGROUNDFinkelstein 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 19635784
- BACKGROUNDAnderson 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 11684524
- BACKGROUNDPowell 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 21654742
- BACKGROUNDSjostrom 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 15616203
- BACKGROUNDSjostrom 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 17715408
- BACKGROUNDDixon 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.