[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Well Cell Global\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100607355","outcomes-of-physiologic-insulin-resensitization-pir-in-patients-with-chronic-kidney-disease-and-type-2-diabetes-mellitus-100607355",false,"NCT07187479","Outcomes of Physiologic Insulin Resensitization (PIR) in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus","Randomized, Open Label Study to Examine the Outcomes of Physiologic Insulin Resensitization in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus","Inclusion Criteria:\n\n* Is age 18 or older (male or female)\n* Have a documented diagnosis of CKD stage 3b, 4, or 5 and T2DM of 6 months or greater prior to screening. Patients may have treatment regimens associated with T2DM that include diabetic oral and\u002For injectable medications including insulin and\u002For GLP-1 receptor agonists.\n* In the opinion of the Investigator, has been on an appropriate, stable regimen for management of any complications present for the past six (6) months.\n* In the opinion of the Investigator, is able to do all of the following:\n\n  * Provide valid informed consent.\n  * Understand and comply with study procedures as presented in the consent process.\n  * Has the capacity or support to attend all required visits.\n* If female, the subject must meet either of the following sets of conditions:\n\n  o Is of non-childbearing potential, defined as meeting either of the following criteria:\n* Age ≥50 years and post-menopausal for at least one (1) year\n* Surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy\n* Is of childbearing potential and meets both of the following criteria:\n\n  * Has a negative serum pregnancy test (beta-human chorionic gonadotropin) at screening.\n  * Agrees to practice an acceptable method of birth control (contraception) from screening until at least 30 days after last study treatment\n\nExclusion Criteria:\n\n* Has in the past two (2) years received treatment for a malignancy.\n* Current pregnancy or intends to become pregnant during the study\n* Has in the past one (1) year used non-prescription opioids or psychoactive drugs.\n* Has in the past six (6) months had a hypoglycemic event requiring urgent care and\u002For administration of glucagon, osteocalcin, or parenteral glucose, unless approved for enrollment by the Medical Monitor.\n* Has within the past one (1) month participated in a clinical study involving either of the following:\n\n  * An investigational drug or procedure for any clinical indication\n  * An investigation method for glucose control using approved agents\n* Is nursing or is planning to nurse during the study.\n* Has at screening a positive test for HIV (4th gen. screen), HBsAg, or HCV viral load.\n* Has at screening, one or more of the following abnormal lab results:\n\n  * Hb \\\u003C8 g\u002FdL\n  * WBC \\\u003C2,000\u002FµL\n  * Platelets \\\u003C50,000\u002FµL\n  * ALT, AST, or Alkaline Phosphatase \\>5x ULN\n  * ALT or AST \\>2.5x ULN, and Total Bilirubin \\>2x ULN\n  * Serum albumin \\\u003C3 g\u002FdL\n* Has - in the opinion of the Investigator - psychiatric, behavioral, cognitive and\u002For clinical dysfunction (whether or not related to known medical illness or drug \u002F alcohol use) that would affect the subject's safety and\u002For compliance.\n* Is on active dialysis at time of screening","ALL","18 Years",{"count":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of this research is to evaluate outcomes of physiologic insulin re-sensitization (PIR) in patients with Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus (T2DM).",[26,27,28],"Chronic Kidney Disease (Stages 4 and 5)","Kidney Disease","Type 2 Diabetes",[30,31,32,33],"chronic kidney disease","type 2 diabetes","diabetes","kidney disease","RECRUITING","2025-10-16",{"date":37,"type":38},"2025-10-20","ACTUAL",{"date":40,"type":38},"2025-10-14",{"date":42,"type":20},"2026-06",{"name":44,"class":45},"Well Cell Global","INDUSTRY",""]