[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658478":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":33,"studyPopulation":23,"armGroups":34,"interventions":47,"overallOfficials":60,"centralContacts":65,"locations":74,"responsibleParty":93,"collaborators":95,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":23,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":23,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":77,"whyStopped":23,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Silesian Centre for Heart Diseases","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":23},[9,13],{"measure":10,"description":11,"timeFrame":12},"Glycemic control","HbA1c value","3 months",{"measure":14,"description":15,"timeFrame":12},"Time in range","Time in range (glucose 70-180 mg\u002Fdl)",[17,20],{"measure":18,"description":19,"timeFrame":12},"Body weight","Body weight measurement",{"measure":21,"description":22,"timeFrame":12},"Lipid profile","Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglicerides",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":23,"primaryPurpose":27,"observationalModel":23,"timePerspective":23,"maskingInfo":28},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":29,"maskingDescription":23,"whoMasked":30},"DOUBLE",[31,32],"PARTICIPANT","INVESTIGATOR","Glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) are the two primary incretin hormones secreted from the small intestine on ingestion of glucose or nutrients to stimulate insulin secretion from pancreatic β cells. They play a role in regulation of blood glucose levels, particularly postprandial glycemia. Lipids and carbohydrates are the most potent stimulators of incretin hormone secretion. Pancreatin is a mixture of digestive enzymes naturally produced by the pancreas, which is used as a medication supporting macronutrient digestion, especially in cases of exocrine pancreatic insufficiency. Evidence suggests that oral pancreatin supplementation enhances the incretin effect by increasing GIP and GLP-1 concentrations, and consequently insulin levels, which translates into a reduction in postprandial glycemia in patients with cystic fibrosis or chronic pancreatitis. Based on a randomized, placebo-controlled, double-blind study, we aim to evaluate the effect of pancreatin on the incretin effect and glycemic control in patients with type 2 diabetes without exocrine pancreatic insufficiency.\n\nWe plan to recruit a total of 100 patients with type 2 diabetes treated with oral antihyperglycemic drugs or insulin, either as monotherapy or in combination. Patients will be randomly divided into 2 groups:\n\n* Group of 50 patients receiving pancreatin 25 000 U with up to 3 main meals daily for 3 months\n* Group of 50 patients receiving placebo with up to 3 main meals daily for 3 months\n\nBaseline assessment:\n\n* Anthropometric parameters: body weight, height, waist-to-hip ratio, body composition (bioelectrical impedance analysis)\n* Laboratory tests: aspartate aminotransferase, alanine aminotransferase, serum amylase, lipid profile, HbA1c, selected cytokines, average glucose concentration from the last 7 days before study start (glucometer - 4 measurements per day), data from the FreeStyle Libre2 continuous glucose monitoring system (2 weeks prior to study start): assessment of TIR (Time in Range 70-180 mg\u002FdL), glycemic variability coefficient (CV), standard deviation (SD), mean glucose concentration, frequency and severity of hypoglycemia; daily insulin requirements from the last 7 days (for insulin-treated patients)\n\nAssessment after study completion:\n\n* Anthropometric parameters: body weight, height, waist-to-hip ratio, body composition (bioelectrical impedance analysis)\n* Laboratory tests: aspartate aminotransferase, alanine aminotransferase, serum amylase, lipid profile, HbA1c, selected cytokines, average glucose concentration from the last 7 days before study end (glucometer - 4 measurements per day), data from the FreeStyle Libre 2 continuous glucose monitoring system (last 2 weeks of study): assessment of TIR, CV, SD, mean glucose concentration, frequency and severity of hypoglycemia; daily insulin requirements from the last 7 days (for insulin-treated patients).\n\nShould pancreatin demonstrate a beneficial effect on glycemic homeostasis, these formulations could serve as a valuable adjunctive therapy for type 2 diabetes.",[35,41],{"label":36,"type":37,"description":38,"interventionNames":39},"Pancreatin","EXPERIMENTAL","Participants receiving pancreatin",[40],"Drug: Pancreatin",{"label":42,"type":43,"description":44,"interventionNames":45},"Control","PLACEBO_COMPARATOR","Participants receiving placebo",[46],"Drug: Placebo",[48,54],{"type":49,"name":36,"description":50,"armGroupLabels":51,"otherNames":52},"DRUG","Pancreatin 25 000 U with each of the 3 main meals daily for 3 months",[36],[53],"ActiveLab",{"type":49,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"Placebo","Placebo capsule with each of the 3 main meals daily for 3 months",[42],[59],"ActivLab Placebo",[61],{"name":62,"affiliation":63,"role":64},"Marta Wróbel, PhD","Department of Internal Medicine, Diabetology and Cardiometabolic Disorders","PRINCIPAL_INVESTIGATOR",[66,70],{"name":62,"role":67,"phone":68,"phoneExt":23,"email":69},"CONTACT","48606873060","mwrobel@sum.edu.pl",{"name":71,"role":67,"phone":72,"phoneExt":23,"email":73},"Paulina Piekarz-Ząbek, MD","‭+48 604 223 652‬","k_bielawa@poczta.fm",[75],{"facility":76,"status":77,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Department of Internal Medicine, Diabetology and Cardiometabolic Disorders, Faculty of Medical Sciences Zabrze","RECRUITING","Zabrze","Silesian Voivodeship","41-800","Poland","PL",{"type":84,"coordinates":85},"Point",[86,87],18.78576,50.32492,{"lat":87,"lon":86},[90,92],{"name":62,"role":67,"phone":91,"phoneExt":23,"email":69},"+48606873060",{"name":71,"role":67,"phone":72,"phoneExt":23,"email":73},{"type":94,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[96],{"name":97,"class":6},"Medical University of Silesia","100658478","phase-4-pancreatin-added-to-standard-antihyperglycemic-therapy-in-patients-with-type-2-diabetes-100658478",false,"NCT07852988","Pancreatin Added to Standard Antihyperglycemic Therapy in Patients With Type 2 Diabetes","The Effect of Pancreatin Added to Standard Antihyperglycemic Therapy on Metabolic Control in Patients With Type 2 Diabetes","Inclusion Criteria:\n\n* Type 2 diabetes diagnosed for at least 12 months\n* Patients treated with oral antihyperglycemic agents and\u002For insulin as monotherapy or combination therapy\n* Age between 35 and 75 years\n* HbA1c: 6.5% - 9.0%\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* Use of incretin-based drugs (GLP-1 receptor agonists, dual GIP and GLP-1 receptor agonists, DPP-4 inhibitors) currently or within the last 3 months\n* History of pancreatic surgery\n* History of chronic pancreatitis\n* History of acute pancreatitis","ALL","35 Years","75 Years",{"count":109,"type":110},100,"ESTIMATED","INTERVENTIONAL",[113],"PHASE4","Medications that enhance the incretin effect (GLP-1 receptor agonists, tirzepatide (GIP\u002FGLP-1 receptor agonist) and DPP-4 inhibitors) are used in treatment of patients with type 2 diabetes. GLP-1 agonists and tirzepatide not only effectively lower blood glucose levels but also promote weight loss-primarily by stimulating the satiety center in the central nervous system - and reduce cardiovascular risk. Evidence suggests that oral pancreatin supplementation also enhances the incretin effect by increasing GIP and GLP-1 concentrations, and consequently insulin levels, which translates into a reduction in postprandial glycemia in patients with cystic fibrosis or chronic pancreatitis. In our study we aim to evaluate the impact of pancreatin on the incretin effect and glycemic control in patients with type 2 diabetes without exocrine pancreatic insufficiency.",[116],"Type 2 Diabetes (T2DM)",[118,119,120,121],"type 2 diabetes","pancreatin","glycemic control","incretin effect","2026-09-23",{"date":124,"type":125},"2026-10-01","ACTUAL",{"date":127,"type":125},"2026-08-01",{"date":129,"type":110},"2027-12-31",{"name":5,"class":6},1]