[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"glycemic-control-for-diabetes-mellitus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:glycemic-control-for-diabetes-mellitus":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,52,82,117,157],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":34,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":4},"100652068","a-prospective-multicenter-study-evaluating-the-metabolic-effects-of-pulsendo-therapy-in-adults-with-type-2-diabetes-100652068",false,"NCT07768631","Study Evaluating the Metabolic Effects of pulsENDO Therapy in Adults With Type 2 Diabetes","A Prospective, Multicenter, Randomized, Sham-Controlled Study Evaluating the Metabolic Effects of pulsENDO Therapy in Adults With Type 2 Diabetes (pULSENDO Study)","pulsENDO","Inclusion Criteria:\n\n1. 22- 75 years of age, inclusive.\n2. T2D diagnosis for at least 6 months.\n3. HbA1c of 7.5-10.5%, inclusive, for participants on 1-3 GLMs or or if on 4 glucose-lowering medications must have HbA1c between 7.5% - 9.0%, inclusive.\n4. BMI 27-40 kg\u002Fm2, inclusive.\n5. On 1-4 non-insulin glucose lowering medications, with no changes in medication or dosing for at least 12 weeks prior to the baseline visit\n6. If on lipid-lowering medications, the medication stable for at least 12 weeks .\n7. Individualized metabolic surgery (IMS) score ≤ 115.\n8. Weight stability (≤5% weight change) for at least 12 weeks\n9. Agree not to donate blood during participation in the study.\n10. Women of childbearing potential must not be pregnant and using an acceptable method of contraception throughout the study.\n11. Willing and able to comply with study visits and study requirements.\n12. Understand and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Diagnosed with type 1 diabetes.\n2. History of diabetic ketoacidosis or hyperosmolar nonketotic coma.\n3. Fasting serum C-peptide \\\u003C1 ng\u002FmL (333pmol\u002Fl).\n4. Current use of insulin, or previous use of any types of insulin for \\>1 month at any time (except for treatment of gestational diabetes) in last 2 years.\n5. Hypoglycemic unawareness.\n6. History of ≥1 severe hypoglycemia episode in past 6 months\n7. Discontinuation of a GLP-1 or a GLP-1\u002FGIP dual-agonist within 6 months of the screening visit following at least one month of treatment.\n8. Known autoimmune disease\n9. Previous GI surgery that has changed GI anatomy\n10. Known history of a structural or functional disorder of the upper GI tract that may impede passage of the device through the upper GI tract or increase risk of tissue damage during an endoscopic procedure\n11. History of gastroparesis.\n12. Acute gastrointestinal illness in the last 7 days.\n13. Known history of inflammatory disease (e.g. Crohn's disease, ulcerative colitis, inflammatory bowel disease), radiation enteritis or other chronic inflammatory disorders of the bowel.\n14. History of chronic or acute pancreatitis.\n15. Active hepatitis or active liver disease, or alanine aminotransferase (ALT) level \\>3.0 times the upper limit of normal (ULN)\n16. Unable to discontinue non-steroidal anti-inflammatory drugs (NSAIDs) from treatment through 4 weeks following the procedure.\n17. Use of systemic glucocorticoids for more than 10 consecutive days within 12 weeks\n18. Use of medications known to affect GI motility (e.g. metoclopramide\u002F Reglan)\n19. Current use of weight loss medications or other weight loss medications including over-the-counter \\[OTC\\] medications or have discontinued weight loss medications within 6 months.\n20. Participation in any structured weight loss program or endoscopic weight loss intervention within 6 months.\n21. Persistent anemia, defined as hemoglobin \\\u003C10 g\u002FdL.\n22. Known history of hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.\n23. History of blood donation or transfusion within 3 months.\n24. Unstable or paroxysmal cardiac arrhythmia.\n25. Any of the following cardiovascular conditions within 6-months prior to screening visit: acute myocardial infarction, unstable angina, cerebrovascular accident (stroke), hospitalization due to congestive heart failure, or history of other significant cardiovascular disease\n26. Heart failure\u002Fvalvular disease: NYHA Class III or IV heart failure, or clinically significant valvular heart disease associated with symptoms or increased procedural\u002Fanesthesia risk\n27. Estimated glomerular filtration rate (eGFR) ≤ 45 ml\u002Fmin\u002F1.73m2\n28. Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, chemotherapy, or radiotherapy within the past 12 months, who have clinically significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the participant a poor candidate for clinical trial participation in the opinion of the investigator.\n29. History of secondary hypothyroidism or inadequately controlled primary hypothyroidism\n30. Presence of any implanted electronic devices that cannot be turned off during the procedure\n31. Presence of duodenal or biliary stents.\n32. Not a candidate for upper GI endoscopy or general anesthesia.\n33. Active illicit substance abuse or alcoholism (\\>2 drinks\u002Fday regularly).\n34. Active malignancy within the last 5 years (excluding non-melanoma skin cancers).\n35. Women who are breastfeeding.\n36. Participating in another ongoing clinical trial of an investigational drug or device.\n37. Current or history within the past 12 months of binge eating disorder, bulimia nervosa, anorexia nervosa, or night eating syndrome.\n38. Clinically significant psychiatric illness, defined as any of the following: (a) psychiatric hospitalization within the past 24 months; (b) a history of suicide attempt, or active suicidal ideation within the past 24 months; or (c) a diagnosis of schizophrenia, other psychotic disorder, or bipolar disorder that is not clinically stable on current management\n39. Critically ill or has a life expectancy \\\u003C5 years.\n40. Are investigator site personnel directly affiliated with this study and\u002For their immediate family member. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.\n\n    Additional exclusion criteria to be evaluated during the screening process:\n41. HbA1c \\\u003C 7.5% or \\> 10.5% at baseline visit.\n42. Uncontrolled hyperglycemia with a glucose level \\>270 mg\u002Fdl (\\>15 mmol\u002FL) after an overnight fast or \\>360 mg\u002Fdl (\\>20 mmol\u002Fl) in a randomly performed measurement that is confirmed by a second measurement (not on the same day) between screening and baseline visit.\n43. Active systemic infection, febrile illness, or antibiotic use within 4 weeks of the Baseline visit.\n44. Vaccination within 14 days of the Baseline visit.\n45. Any severe hypoglycemic event since the screening visit.\n46. Poorly controlled hypertension, as evidenced by a mean of 3 separate blood pressure measurements \\>180 mmHg (systolic) or \\>100 mmHg (diastolic)\n47. Women of child-bearing potential with a positive urine pregnancy test at baseline visit.\n48. LA Grade C or greater esophagitis on endoscopy.\n49. Abnormalities of the GI tract preventing endoscopic access to the duodenum.\n50. Anatomic abnormalities in the duodenum or proximal jejunum that would preclude the completion of the treatment procedure, including tortuous anatomy.\n51. Endoscopic observation of upper gastrointestinal abnormalities such as ulcers, polyps in the area to be treated, varices, strictures, congenital or intestinal telangiectasia.\n52. Any other anatomical or endoscopic abnormalities\u002Fcharacteristics that, in the opinion of the investigator, would preclude safe use of the investigational device or procedure.","ALL","22 Years","75 Years",{"count":21,"type":22},320,"ESTIMATED","INTERVENTIONAL",[25],"NA","This is a prospective, multicenter, randomized, double-blind, sham-controlled, adaptive study evaluating the pulsENDO system in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications (GLMs). The primary objective of this study is to demonstrate that pulsENDO therapy is superior to sham control for improving glycemic control in adults with type 2 diabetes.",[28,29,30,31,32,33],"Diabetes Type 2","Diabetes","Diabetes (DM)","Weight Change","Glycemic Control","Glycemic Control for Diabetes Mellitus",[35,36,37,38,39],"blinded","multicenter","randomized","doudenal regeneration","type 2 diabetes","NOT_YET_RECRUITING","2026-08-14",{"date":43,"type":44},"2026-08-18","ACTUAL",{"date":46,"type":22},"2027-01-01",{"date":48,"type":22},"2030-11-01",{"name":50,"class":51},"Endogenex, Inc.","INDUSTRY",{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":23,"phases":64,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100635790","video-based-lifestyle-counseling-in-adults-with-type-2-diabetes-100635790","NCT07557264","Video-Based Lifestyle Counseling in Adults With Type 2 Diabetes.","Effectiveness of a Video-Based Lifestyle Intervention Delivered by Patients' Own Primary Care Physicians Versus an Unfamiliar Physician in Adults With Type 2 Diabetes Mellitus","LIDM2","Inclusion Criteria:\n\n* Adults aged 18-65 years\n* Diagnosis of type 2 diabetes mellitus\n* Under medical follow-up in participating centers\n* Access to the internet and a smartphone\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Type 1 diabetes or other specific forms of diabetes\n* Severe acute or unstable medical condition\n* Contraindication to diet or exercise\n* Severe psychiatric disorder\n* Eating disorder\n* Physical disability limiting physical activity\n* Participation in another structured weight-loss or lifestyle program\n* No medical visit in the last 2 years","18 Years","65 Years",{"count":63,"type":22},156,[25],"This study evaluates the effectiveness of a 3-month video-based lifestyle intervention, focused on promoting healthy lifestyle habits (healthy eating and increased physical activity), on adults with type 2 diabetes mellitus (DM2). Participants will be randomly allocated to receive the intervention either delivered by their own physician (experimental group) or by a physician unknown to them (control group). Assessment will include sociodemographic variables, glycated hemoglobin \u002F HbA1c (primary outcome), body mass index, blood pressure, glycemic and lipid metabolism variables, physical activity level, adherence to the Mediterranean diet, therapeutic alliance, and health-related quality of life. The randomization process will be stratified according to HbA1c, therapeutic alliance, age, and sex.",[67,33,68,69,70],"Diabetes Mellitus (Type 2)","Physical Activity","Healthy Eating","Therapeutic Alliance","2026-04-22",{"date":73,"type":44},"2026-04-29",{"date":75,"type":22},"2026-09-01",{"date":77,"type":22},"2027-05-01",{"name":79,"class":80},"Cardenal Herrera University","OTHER",1,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":23,"phases":93,"briefSummary":95,"conditions":96,"keywords":101,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":81},"100607292","phase-2-evaluation-of-a-novel-insulin-sensitizer-in-people-with-type-1-diabetes-100607292","NCT07186660","Evaluation of a Novel Insulin Sensitizer in People With Type 1 Diabetes","Evaluation of a Novel Insulin Sensitizer on Glycemic Control, Insulin Usage, and Cardiovascular Biomarkers in People With Type 1 Diabetes Who Use Closed-loop Automated Insulin Delivery","WBH003","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. History of type 1 diabetes for at least one year\n4. Age 18-45 years\n5. HbA1c \\\u003C10%\n\n   * BMI 18-35 kg\u002Fm2. Within this criterion, participants must have either BMI ≥25 or total daily insulin dose of ≥0.5 units\u002Fkg\u002Fday.\n   * Currently utilizing closed-loop AID therapy that is compatible with Dexcom G7 CGM.\n   * On stable regimen of non-diabetic medications for the last 6 months.\n   * All screening labs within normal limits or not clinically significant.\n   * Ability to take oral medication and be willing to adhere to the study drug\u002Fplacebo for 12 weeks.\n   * For females and males of reproductive potential: agreement to use adequate contraception during study participation and for an additional 2 weeks after the end of CIR-0602K administration.\n   * For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study intervention.\n   * Agreement to adhere to Lifestyle Considerations throughout study duration.\n\nExclusion Criteria:\n\n* Current Pregnancy or currently breastfeeding.\n* History of smoking tobacco products within the last two years.\n* History of alcohol abuse or illicit drug abuse within 6 months of screening.\n* Known history of human immunodeficiency virus (HIV).\n* History of other significant disease (e.g., cardiac, cerebrovascular, gastrointestinal, liver, renal, or endocrine) that could, in the investigator's view, alter study outcomes\n* Any surgical or medical condition which may significantly alter the absorption of the study drug including but not limited to the following: history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, bowel resection, gastric bypass, gastric stapling, or gastric banding, currently active inflammatory bowel syndrome.\n* Current use of any antihyperglycemic medication beyond insulin (i.e., GLP-1 receptor agonists, SGLT2 inhibitors, etc.).\n* Unstable doses (i.e., dose change within the last 4 months) of vasoactive medications (e.g., calcium-channel blockers, statins, angiotensin-converting enzyme inhibitors, diuretics, nitrates, alpha-blockers, beta-blockers, etc.).\n* Daily use of anti-inflammatory medications (e.g., ibuprofen, aspirin, prednisone, dexamethasone, etc.).\n* Diagnosis of peripheral neuropathy (assessed by screening monofilament exam).\n* Macroalbuminuria (i.e., urine albumin: creatinine \\>300 mg per g).\n* Retinopathy beyond mild, nonproliferative retinopathy.\n* History of Level 3 hypoglycemia within the last 12 months.\n* History of diabetic ketoacidosis (DKA) within the last 12 months.\n* Screening electrocardiogram (ECG) findings indicative of arrhythmia, sinus node disease, or ischemic heart disease.\n* Screening oxygen saturation \\\u003C90%\n* History of hypersensitivity or prior adverse reaction to the study drug, closely-related compounds, or any of the stated ingredients.\n* Use of concomitant medications with a known significant metabolism by CYP2C8 or CYP2C (including paclitaxel, phenytoin, warfarin, celecoxib, tolbutamide, or repaglinide) for the duration of the study.\n* Participation in an investigational study (other than a non-treatment registry study) or received an investigational drug withing 30 days or 5 half-lives (whichever is longer) prior to randomization.","45 Years",{"count":92,"type":22},40,[94],"PHASE2","The purpose of this study is to see if the study drug CIR-0602K will improve glucose time-in-range and\u002For lower total daily insulin dose in people with type 1 diabetes who are using closed-loop automated insulin delivery. Researchers will compare CIR-0602K to a placebo (a look-alike substance that contains no drug) to see if it achieves the investigational endpoints. If the study results show that the drug works to increase time-in-range and lower insulin doses, this will lead to further studies which may then make the drug available to the public.",[97,33,98,99,100],"Type 1 Diabetes (T1D)","Insulin","Ketones","Cardiovascular Health",[102,103,104,105,106],"Type 1 Diabetes","closed loop technology","time-in-range","adjunct therapy","cardiovascular health","RECRUITING","2026-02-23",{"date":110,"type":44},"2026-02-25",{"date":112,"type":44},"2026-02-22",{"date":114,"type":22},"2028-09",{"name":116,"class":80},"University of Virginia",{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":23,"phases":127,"briefSummary":129,"conditions":130,"keywords":139,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":81},"100585948","phase-3-semaglutide-treatment-in-type-1-diabetes-100585948","NCT06909006","Semaglutide Treatment in Type 1 Diabetes","Obesity and Semaglutide in Type 1 Diabetes Therapy: A Multicentre, Randomised, Double-Blinded, Placebo-Controlled, Investigator-Initiated Trial","OBES1TY","Inclusion Criteria:\n\n* Type 1 Diabetes for more than 3 years\n* BMI ≥ 30 or ≥ 27 and atleast one comorbidity (hypertension, hypercholesterolemia, microalbuminuria, ischemic heart disease, history of stroke, atherosclerosis or arthrosis\n\nExclusion Criteria:\n\n* Treated with GLP1-RAs within last 6 months\n* Known intolerance for semaglutide\n* Other forms of diabetes\n* Pregnant or nursing women\n* Fertile women not using chemical (hormonal) or mechanical (spiral) contraceptives\n* Liver disease with elevated plasma alanine aminotransferase (ALT) \\> five times and plasma aspartate aminotransferase (AST) \\> five times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)\n* Acute or chronic pancreatitis\n* Cancer, unless in complete remission for \\> 5 years or unless basocellular carcinomas\n* History of thyroid adenoma or carcinoma\n* Alcohol\u002Fdrug abuse\n* Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation\n* Receipt of an investigational drug within 30 days prior to visit 0 \u002F Simultaneous participation in any other clinical intervention trial",{"count":126,"type":22},122,[128],"PHASE3","The goal of this clinical trial is to investigate the efficacy of semaglutide on body weight, insulin dose requirements and improvements in glucose control and safety aspects in regards to risk of hypoglycemia and diabetic ketoacidosis for patients with established Type 1 Diabetes.",[131,132,133,134,135,136,137,138,33],"Obesity in Diabetes","Obesity\u002FTherapy","Type 1 Diabetes Mellitus (T1DM)","Insulin Sensitivity\u002FResistance","Semaglutide","Lipidomics","Metabolomics","Weight Loss",[135,140,102,141,142,143,144,145,146,147],"Obesity","Obese Type 1 Diabetics","Insulin sensitivity","Insulin resistance","Weight loss","GLP1-RA","GLP1","Wegovy","2025-08-04",{"date":150,"type":44},"2025-08-08",{"date":152,"type":22},"2025-10",{"date":154,"type":22},"2028-06",{"name":156,"class":80},"Nordsjaellands Hospital",{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":61,"enrollmentInfo":164,"targetDuration":4,"studyType":23,"phases":166,"briefSummary":167,"conditions":168,"keywords":170,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":81},"100587924","meal-frequency-and-glycemic-control-in-individuals-with-type-1-diabetes-100587924","NCT06934707","Meal Frequency and Glycemic Control in Individuals With Type 1 Diabetes","Meal Frequency, Glycemic Control and Variability in Individuals With Type 1 Diabetes: a Randomized Crossover Clinical Trial","Inclusion Criteria:\n\n* • Adults (18 to 60 years old) with a medical diagnosis of type 1 diabetes mellitus\n\n  * Individuals who perform carbohydrate counting\n  * Individuals diagnosed \\> 12 months ago\n  * Perform daily glycemic control using a blood glucose monitor or use of a glucose sensor\n  * Have the ability to understand and be able to adhere to the proposed interventions.\n  * Complete a detailed 3-day food record for one week prior to the intervention and record episodes of hypoglycemia (\\\u003C70 mg\u002FdL) and hyperglycemia (\\>180 mg\u002FdL)\n  * Able and willing to provide written informed consent and comply with the requirements of the study protocol.\n\nExclusion Criteria:\n\n* Individuals with glycated hemoglobin ≥ 11%\n* Individuals who are using NPH insulin\n* Retinopathy with vision deficit that limits the activities proposed in the disciplines.\n* Individuals with gastrointestinal disease such as celiac disease, Crohn's disease and Irritable Bowel Syndrome (IBS)\n* History of bariatric surgery\n* That you are following a carbohydrate, protein and\u002For fat restriction diet\n* Individuals with BMI ≥ 40kg\u002Fm2\n* Chronic kidney disease with estimated glomerular filtration \\\u003C30mL\u002Fmin per 1.73 m2.\n* Liver failure or chronic viral hepatitis\n* Active or progressive neurodegenerative disease\n* Use of medications that affect glucose metabolism (corticosteroids and immunosuppressants) or cause weight loss. ● Treatment with weight-reducing agents (e.g., orlistat, sibutramine, topiramate, liraglutide) in the last 12 weeks prior to screening.\n* Treatment with thyroid hormone that has not been maintained at a stable dose in the last 12 weeks prior to screening.\n* History of active substance abuse (including alcohol) in the last year.\n* Serious psychiatric illness: Mood disorders, anxiety disorders, severe psychotic disorders, and personality disorders that are revealed or identified in the clinical evaluation, listed or reported in the medical record, and that have no clinical findings.\n* Predisposition to or diagnosis of eating disorders.\n* Women who are pregnant, intending to become pregnant during the study period, or who are breastfeeding.\n* Hyperglycemia characterized by acute symptoms: polyuria, polydipsia, and\u002For weight loss in the last 3 months. ● Metabolic and acute complications of diabetes such as ketoacidosis or hyperosmolar coma.\n* Night workers who work after 10 pm.",{"count":165,"type":22},27,[25],"The goal of this clinical trial is to examine the effect of 3 versus 6 daily meals of isocaloric diets on glycemic control and variability in individuals with type 1 diabetes. Participants will be randomized in a crossover clinical trial and will receive two different types of isocaloric diet interventions, in 3 meals\u002Fday (calorie distribution: 30% at breakfast, 40% at lunch and 30% at dinner) or 6 meals\u002Fday (calorie distribution: 20% at breakfast, 10% at morning snack, 30% at lunch, 10% at afternoon snack, 25% at dinner and 5% at evening snack), for three weeks, with a 4-week washout period between diets.",[97,169,33],"Nutrition Therapy",[171,172,173,174],"type 1 Diabetes","glycemic control","diet","meal frequency","2025-04-11",{"date":177,"type":44},"2025-04-18",{"date":179,"type":22},"2025-04-20",{"date":181,"type":22},"2027-12-29",{"name":183,"class":80},"Hospital de Clinicas de Porto Alegre"]