Physiologic insulin resensitization treatment for adults with type 2 diabetes

Trial details

Who runs it

University of Alabama at Birmingham

Trial code

NCT07906470

Record updated

30 October 2026

Original description

The purpose of the study is to assess the outcomes of Physiologic Insulin Resensitization (PIR) treatment compared to standard of care (SOC) on patients with a diagnosis of Type 2 diabetes mellitus (T2DM). Participants will be in this study for 24 to 26 weeks.Read full original descriptionShow less

Open Label Study to Examine the Outcomes of Physiologic Insulin Resensitization in Patients With Type 2 Diabetes Mellitus

The purpose of the study is to assess the outcomes of Physiologic Insulin Resensitization (PIR) treatment compared to standard of care (SOC) on patients with a diagnosis of Type 2 diabetes mellitus (T2DM). Participants will be in this study for 24 to 26 weeks.

Inclusion: Is 18 or older (male or female); Have a documented diagnosis of T2DM of 6 months or greater prior to screening and an HbA1c >7.5. Patients may have treatment regimens associated with T2DM that include diabetic oral and/or injectable medications including insulin and/or GLP-1 receptor agonists; 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; In the opinion of the Investigator, is able to do all of the following:; Provide valid informed consent; Understand and comply with study procedures as presented in the consent process; Has the capacity or support to attend all required visits; If female, the subject must meet either of the following sets of conditions:; Is of non-childbearing potential, defined as meeting either of the following criteria:; Age ≥50 years and post-menopausal for at least one (1) year; Surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy; Is of childbearing potential and meets both of the following criteria:; Has a negative serum pregnancy test (beta-human chorionic gonadotropin) at screening; Agrees to practice an acceptable method of birth control (contraception) from screening until at least 30 days after last study treatment.

Exclusion: Has in the past two (2) years received treatment for a malignancy; Has in the past one (1) year used non-prescription opioids or non- prescriptive psychoactive drugs; Has - in the opinion of the Investigator - psychiatric, behavioral, cognitive and/or clinical dysfunction (whether or not related to known medical illness or drug / alcohol use) that would affect the subject's safety and/or compliance; Has in the past six (6) months had a hypoglycemic event requiring urgent care and/or administration of glucagon, osteocalcin, or parenteral glucose, unless approved for enrollment by the Medical Monitor; Has within the past one (1) month participated in a clinical study involving either of the following:; An investigational drug or procedure for any clinical indication; An investigation method for glucose control using approved agents; Current pregnancy or intends to become pregnant during the study; Is nursing or is planning to nurse during the study; Is on active dialysis at time of screening; Weighs more than 450 lbs or has a waist circumference that exceeds the size of the MR bore when the coil is placed; Has had recent iodine or barium-based contrast imaging; Has an implanted device with metal incompatible with MR scanning, or the presence of any other metal in the body (such as shrapnel); Is unable to remain still for extended periods of time or to hold breath for 10 seconds; Is claustrophobic.

ClinicalTrials.gov NCT07906470