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Physiologic Insulin Resensitization (PIR) Treatment in Patients With a Diagnosis of Type 2 Diabetes Mellitus (T2DM)

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

Sponsor
University of Alabama at Birmingham (Academic or other)
Enrollment
60 planned
Conditions
Type 2 Diabetes Mellitus
Interventions
Physiologic insulin resensitization (PIR)
Ages
adults, older adults
Registry
NCT07906470

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • Changes in insulin sensitivity and beta-cell function using a modified frequently sampled intravenous glucose tolerance test (IVGTT) using insulin sensitivity index (SI) (x10-4 min-1/[μlU/mL]) unit of measurement.
  • Changes in percent body fat with dual-energy-X-ray absorption (DXA).
  • Changes in ectopic fat (liver, visceral; fat fraction or square cm) using magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS).

History

  1. Study completion expected

  2. Primary completion expected

  3. Registered

  4. Started