University of Alabama at Birmingham
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.
This study will include two cohorts. The assessments include a three-hour intravenous glucose tolerance test (IVGTT) for insulin sensitivity and two types of imaging. The PIR cohort will undergo these assessments at baseline, 12 weeks, and 24 weeks, plus one additional IVGTT at 26 weeks. In addition, the PIR group will be required to undergo a three-hour infusion of insulin once or twice every week for weeks 0-24. The control cohort will undergo insulin sensitivity and body composition assessments at baseline,12 weeks, and 24 weeks.
Inclusion Criteria: 1. Is 18 or older (male or female) 2. 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. 3. 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. 4. In the opinion of the Investigator, is able to do all of the following: * Provide valid informed consent. * Under…
The PIR group will be required to undergo a three-hour infusion of insulin once or twice every week for weeks 0-24.
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