Outcomes of Physiologic Insulin Resensitization (PIR) in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWell Cell Global
About this trial
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).
Eligibility criteria
Qualifiers
Is age 18 or older (male or female)
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/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.
Provide valid informed consent.
Disqualifiers
Has in the past two (2) years received treatment for a malignancy.
Current pregnancy or intends to become pregnant during the study
Has in the past one (1) year used non-prescription opioids or psychoactive drugs.
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.
Trial design
Treatments tested in this trial
- Physiologic Insulin Resensitization (PIR)
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov