[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pancreatic-insufficiency\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pancreatic-insufficiency":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,81,102],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100418635","phase-2-glp-1-agonist-therapy-in-cystic-fibrosis-related-glucose-intolerance-100418635",false,"NCT04731272","GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance","Effect of GLP-1 Agonist Therapy on Insulin Secretion in Adults With Pancreatic Insufficient Cystic Fibrosis and Abnormal Glucose Tolerance: a Randomized, Open-label, Cross-over Trial","Inclusion Criteria:\n\n* 1\\. Male or female, aged ≥18 years on date of consent\n* 2\\. Confirmed diagnosis of CF, defined by positive sweat test or Cystic Fibrosis transmembrane conductance regulator (CFTR) mutation analysis according to Cystic Fibrosis Foundation (CFF) diagnostic criteria.\n* 3\\. Pancreatic insufficiency defined by clinical requirement for pancreatic enzyme replacement.\n* 4\\. Abnormal glucose tolerance defined by OGTT criteria for EGI, IGT, or CFRD, or diagnosed CFRD.\n\n  1. There will be no restriction on enrollment of individuals with CFRD but without fasting hyperglycemia (fasting hyperglycemia is defined as fasting glucose ≥126 mg\u002FdL)\n  2. Individuals with CFRD and fasting hyperglycemia (defined as above or by the use of basal insulin therapy) must also have a HbA1c ≤8% and a random (non-fasting) C-peptide ≥1.2 ng\u002FmL17; enrollment of this subgroup will be limited to n =10.\n* 5\\. Ability to take subcutaneous medication and be willing to adhere to the weekly administration regimen and complete study specific procedures (MMTT)\n* 6\\. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 weeks after the end of dulaglutide or observation administration; oral contraceptives, intra-uterine devices, Norplant®, Depo-Provera®, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable\n\nExclusion Criteria:\n\n* 1\\. BMI \\\u003C19 kg\u002Fm2\n* 2\\. Presence of first-degree atrioventricular block or other evidence for cardiac conduction system or structural heart defects\n* 3\\. Pregnancy or lactation; a negative urine pregnancy test will be required at enrollment\n* 4\\. Known allergic reactions to any GLP-1 agonist, and any history of severe hypersensitivity reactions (anaphylaxis or angioedema)\n* 5\\. Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2 (MEN2)\n* 6\\. Pulmonary exacerbation requiring IV antibiotics or systemic glucocorticoids within 4 weeks prior to study procedures\n* 7\\. Gastrointestinal symptom exacerbation defined by current nausea\u002Fvomiting or diarrhea\n* 8\\. Established diagnosis of non-CF diabetes (e.g. type 1 diabetes) or CFRD with fasting hyperglycemia (fasting glucose ≥126 mg\u002FdL \\[use of prandial insulin or repaglinide will be permitted\\])\n* 9\\. History of clinically symptomatic pancreatitis within the last year\n* 10\\. Prior lung, liver or other solid organ transplant\n* 11\\. Severe CF liver disease, as defined by the presence of portal hypertension\n* 12\\. History of fundoplication-related dumping syndrome\n* 13\\. Hemoglobin \\\u003C10 g\u002FdL, within 90 days of study procedures or at screening\n* 14\\. Abnormal renal function, within 90 days of study procedures or at screening; defined as creatinine \\>2x upper limit of normal (ULN) or potassium \\>5.5mEq\u002FL on non-hemolyzed specimen\n* 15\\. History of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk to the subject","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Diabetes is a major co-morbidity in pancreatic insufficient cystic fibrosis (PI-CF) and associated with worse outcomes. While reduced β-cell mass contributes to the insulin secretory defects that characterizes cystic fibrosis-related diabetes (CFRD), other modifiable determinants appear operative in the emergence and progression of abnormal glucose tolerance towards diabetes. Identifying interventions to preserve β-cell function are crucial for delaying and potentially preventing CFRD development. In this study, we hypothesize that weekly administration of the long-acting glucagon-like peptide-1 (GLP-1) agonist dulaglutide will improve defective early-phase insulin secretion and improve glucose tolerance during a mixed-meal tolerance test.",[26,27,28,29],"Cystic Fibrosis","Pancreatic Insufficiency","Abnormal Glucose Tolerance","Diabetes",[31,32,33,34],"Cystic Fibrosis Related Diabetes","Glucose Intolerance","Insulin Secretion","Glucagon-Like Peptide-1 (GLP-1)","RECRUITING","2026-05-13",{"date":38,"type":39},"2026-05-18","ACTUAL",{"date":41,"type":39},"2021-07-16",{"date":43,"type":20},"2028-06-30",{"name":45,"class":46},"University of Pennsylvania","OTHER",2,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100629789","breath-test-based-assessment-of-sibo-in-chronic-pancreatitis-and-partial-pancreatectomy-100629789","NCT07479238","Breath Test-Based Assessment of SIBO in Chronic Pancreatitis and Partial Pancreatectomy","Prevalence of SIBO in Patients With Chronic Pancreatitis and After Partial Pancreatectomy: Assessment by Glucose, Lactulose and Mixed Triglyceride Breath Tests.","DCP-PCT-EPI","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Ability and willingness to participate in the study and to comply with study procedures\n* Diagnosis of chronic pancreatitis with pancreatic exocrine insufficiency (defined as fecal elastase \\\u003C 200 µg\u002Fg of stool)\n* Ongoing pancreatic enzyme replacement therapy (PERT) with persistent gastrointestinal symptoms (including abdominal pain, dyspepsia, bloating, excessive flatulence, diarrhea, or steatorrhea) or unintentional weight loss ≥ 10% within the previous 6 months despite adequate PERT dosing (≥ 40,000 IU per main meal and half dose for snacks)\n* Patients with ampullary or pancreatic tumors who underwent partial pancreatectomy and subsequently developed pancreatic exocrine insufficiency with persistent gastrointestinal symptoms\n* Indication to undergo glucose, lactulose, and mixed triglyceride breath tests as part of routine clinical practice\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years or \\> 75 years\n* Pancreatic adenocarcinoma or bile duct tumors under active or previous adjuvant therapy\n* Moderate to severe liver disease\n* Severe chronic kidney disease (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²)\n* History of major gastrointestinal surgery, including total pancreatectomy\n* Presence of other active organic gastrointestinal diseases\n* Diabetic gastroparesis\n* Known celiac disease\n* Obstructive jaundice\n* Liver cirrhosis Child-Pugh class C\n* Recent or ongoing infections\n* Severe chronic obstructive pulmonary disease (COPD)\n* Symptomatic thyroid disorders\n* Use of antibiotics, laxatives, probiotics, or prokinetic agents within 4 weeks prior to breath testing\n* Inability or refusal to undergo study procedures\n* Inability or refusal to provide informed consent","75 Years",{"count":58,"type":20},100,"OBSERVATIONAL","Pancreatic exocrine insufficiency (PEI) results from reduced pancreatic enzyme secretion, leading to malabsorption, malnutrition, and impaired quality of life. Although pancreatic enzyme replacement therapy (PERT) is the standard treatment, some patients remain symptomatic despite apparently adequate therapy. Possible causes include suboptimal dosing or concomitant conditions such as small intestinal bacterial overgrowth (SIBO). This study aims to determine the prevalence of SIBO in symptomatic PEI patients despite adequate PERT and to identify treatable causes of persistent symptoms using non-invasive diagnostic tests, with the goal of improving nutritional status and quality of life.",[62,27,63,64],"SIBO","Chronic Pancreatitis","Pancreatic Surgey",[66,67,68,69],"Pancreatic exocrine insufficiency","Chronic pancreatitis","enzyme replacement therapy","Small intestinal bacterial overgrowth","NOT_YET_RECRUITING","2026-04-09",{"date":73,"type":39},"2026-04-13",{"date":75,"type":20},"2026-04-30",{"date":77,"type":20},"2028-04-26",{"name":79,"class":46},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",1,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":47},"100592609","phase-1-dorzagliatin-in-pancreatic-insufficient-cystic-fibrosis-100592609","NCT06995651","Dorzagliatin in Pancreatic Insufficient Cystic Fibrosis","Pharmacokinetic and Pharmacodynamic Effects of Dorzagliatin in Pancreatic Insufficient-Cystic Fibrosis: A Randomized Double-blind, Cross-over Trial","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Male or female, aged ≥18 years on date of consent.\n4. Confirmed diagnosis of CF, defined by positive sweat test or CFTR mutation analysis according to CFF diagnostic criteria.\n5. Pancreatic insufficiency defined by clinical requirement for pancreatic enzyme replacement.\n6. Abnormal glucose tolerance defined by OGTT criteria for EGI, IGT, or CFRD, or diagnosed CFRD.\n7. There will be no restriction on enrollment of individuals with CFRD but without fasting hyperglycemia (fasting hyperglycemia is defined as fasting glucose ≥126 mg\u002FdL)\n\n   a. Individuals with CFRD and fasting hyperglycemia (defined as above or by the use of basal insulin therapy) must also have a HbA1c ≤8% and a random (non-fasting) C- peptide ≥1.2 ng\u002FmL \\[15\\].\n8. For females of reproductive potential: use of highly effective contraception method for the during of study participation; oral contraceptives, intra-uterine devices, Norplant®, Depo- Provera®, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable.\n\nExclusion Criteria:\n\n1. Established diagnosis of non-CF diabetes (e.g. type 1 diabetes).\n2. Pregnancy or lactation; a negative urine pregnancy test will be required at enrollment.\n3. Pulmonary exacerbation requiring IV antibiotics or systemic glucocorticoids within 4 weeks prior to randomization.\n4. Treatment with either CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, indinavir, ritonavir, saquinavir, telithromycin, boceprevir, nelfinavir, telaprevir, conivaptan, nefazodone, etc.) or inducers (e.g. phenobarbital, other barbiturates, carbamazepine, phenytoin, rifampicin, dexamethasone, etc.).\n5. Use of herbal remedies, including St. John's Wort within 14 days prior to dosing.\n6. Change in CFTR modulator therapy in the previous 3 months.\n7. History of clinically symptomatic pancreatitis within the last year.\n8. Prior lung, liver or another solid organ transplant.\n9. Abnormal kidney function: creatinine \\>2x upper limit of normal (ULN) or potassium \\>5.5mEq\u002FL on non-hemolyzed specimen.\n10. Abnormal liver function: persistent elevation of liver function tests \\>2.0 times ULN.\n11. Uncontrolled hyperlipidemia: triglycerides \\>500 or cholesterol \\>250 mg\u002Fdl.\n12. Hyperuricemia: serum uric acid \\>1.5 times ULN.\n13. Anemia: hemoglobin \\\u003C10 g\u002FdL.\n14. History of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk to the subject.",{"count":89,"type":20},15,[91],"PHASE1","This study is designed to determine the pharmacokinetic and pharmacodynamic response of dorzagliatin 50 mg twice daily following 7-day administration in individuals with pancreatic insufficient cystic fibrosis and abnormal glucose tolerance when compared to randomized, double-blind 7-day administration of placebo in a cross-over fashion. We hypothesize that dorzagliatin administration will result in significant drug concentrations and improved glucose tolerance, early-phase insulin secretion, glucagon suppression, and hepatic glycogen storage assessed during a standardized mixed-meal tolerance test.",[27,94],"Cystic Fibrosis-related Diabetes","2026-04-03",{"date":71,"type":39},{"date":98,"type":39},"2025-10-21",{"date":100,"type":20},"2027-07",{"name":45,"class":46},{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":109,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":21,"phases":112,"briefSummary":114,"conditions":115,"keywords":116,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":80},"100197851","beta-cell-response-to-incretin-hormones-in-cystic-fibrosis-100197851","NCT01851694","Beta-cell Response to Incretin Hormones in Cystic Fibrosis","Determination of Beta-cell Responsiveness to the Incretin Hormones GLP-1 and GIP in Cystic Fibrosis","Inclusion Criteria:\n\n1. Confirmed diagnosis of cystic fibrosis, defined by positive sweat test or CFTR mutation analysis according to CFF diagnostic criteria,\n2. Age greater than or equal to 18y on date of consent\n3. Pancreatic insufficiency\n4. Recent OGTT consistent with Indeterminate-GT, IGT, CFRD w\u002Fo fasting hyperglycemia, or an established diagnosis of CFRD without fasting hyperglycemia\n5. For female subjects, negative urine pregnancy test at enrollment.\n\nControl Subjects:\n\n1. No history of cystic fibrosis.\n2. Age ≥ 18y on date of consent.\n3. Recent OGTT consistent with NGT.\n4. For female subjects, negative urine pregnancy test at enrollment.\n\nExclusion Criteria:\n\n1. Established diagnosis of non-CF diabetes (i.e. T1D) or CFRD with fasting hyperglycemia (fasting glucose greater than126 mg\u002FdL)\n2. History of clinically symptomatic pancreatitis within last year\n3. Prior lung or liver transplant\n4. Severe CF liver disease, as defined by portal hypertension\n5. Fundoplication-related dumping syndrome\n6. Medical co-morbidities that are not CF-related or are unstable per investigator opinion (i.e. history of bleeding disorders, immunodeficiency)\n7. Acute illness or changes in therapy (including antibiotics) within 6 weeks prior to study procedures\n8. Treatment with oral or intravenous corticosteroids within 6 weeks of study\n9. Hemoglobin less than10g\u002FdL, within 90 days of Visit 1 or at Screening\n10. Abnormal renal function, within 90 days of Visit 1 or at Screening; defined as Creatinine greater than 2x upper limit of normal (ULN) or potassium greater than 5.5mEq\u002FL on non-hemolyzed specimen\n11. Inability to perform study specific procedures (MMTT, GPA)\n12. Subjects, who in study team opinion, may be non-compliant with study procedures.\n\nControl Subjects who will be exposed to GIP only:\n\n1. History of clinically symptomatic pancreatitis.\n2. History of liver disease.\n3. History of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk to the subject.\n4. Hemoglobin \\\u003C10g\u002FdL, within 90 days of GPA test or at Screening.\n5. Abnormal renal function, within 90 days of GPA test or at Screening; defined as creatinine \\> 2x upper limit of normal (ULN) or potassium \\> 5.5mEq\u002FL on non-hemolyzed specimen.\n6. Inability to perform study specific procedures (MMTT, GPA).\n7. subjects, who in study team opinion, may be non-compliant with study procedures.\n8. elevation of serum amylase or lipase \\> 1.5x ULN within 90 days of GPA test.",true,{"count":111,"type":20},45,[113],"NA","In recent years, diabetes has emerged as one of the most significant co-diseases that many Cystic Fibrosis (CF) patients develop. Type 1 (T1D) and Type 2 (T2D) diabetes results when either the body does not make enough insulin or the body does not respond correctly to this insulin, respectively. Insulin is a hormone which is made by cells in the pancreas and helps carry glucose (sugar) from the food we eat to the cells of the body for energy. While cystic fibrosis related diabetes (CFRD) has many features similar to both T1D and T2D, patients with CF may not have the same symptoms as either T1D or T2D patients. Currently, there is little understanding of CFRD and the best options for treatment remain unclear.\n\nThe purpose of this research study is to examine and understand the various mechanisms that contribute to CFRD and gain a better understanding of potential means to treat CFRD. In particular, we plan to study the effects of incretin hormones that can enhance insulin production in CF patients.\n\nEnrollment is complete for the protocol as initially written. In order to further study the role of the incretin hormone on Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) function , we have received approval to extend our investigation to include the following study groups:\n\n* Cystic Fibrosis participants with normal glucose tolerance\n* Non-Cystic Fibrosis controls",[26,27],[26,29,117,118,119],"Pancreatic insufficiency","Cystic Fibrosis with Normal Glucose Tolerance","Non-Cystic Fibrosis control group","2026-01-13",{"date":122,"type":39},"2026-01-14",{"date":124,"type":4},"2013-05",{"date":126,"type":20},"2026-12",{"name":45,"class":46}]