Physiologic Insulin Resensitization for Chronic Kidney Disease and Type 2 Diabetes

Overseen By Samantha Villaverde

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Well Cell Global

Must not be taking: Non-prescription opioids, Psychoactive drugs

Disqualifiers: Malignancy, Pregnancy, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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).

Who Is on the Research Team?

Sungchun Lee, MD

Principal Investigator

Arizona Kidney Disease and Hypertension Centers

Are You a Good Fit for This Trial?

This trial is for adults with both Chronic Kidney Disease (stages 3b, 4, or 5) and Type 2 Diabetes Mellitus. They should have stable health conditions for the past six months and agree to use birth control if of childbearing potential. Exclusions include recent severe hypoglycemia, other clinical study participation within a month, certain infections like HIV/HBV/HCV, abnormal lab results, psychiatric issues affecting compliance, recent cancer treatment or drug abuse.

Inclusion Criteria

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

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

I am 18 years old or older.

Exclusion Criteria

Current pregnancy or intends to become pregnant during the study

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Physiologic Insulin Resensitization (PIR) or Standard of Care (SOC) treatment

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Physiologic Insulin Resensitization (PIR)

Trial Overview The trial is testing Physiologic Insulin Resensitization (PIR) in patients who have both Chronic Kidney Disease and Type 2 Diabetes Mellitus. It aims to see how well PIR works in improving insulin sensitivity and overall diabetes management in this specific patient group.

How Is the Trial Designed?

Group I: Physiologic Insulin Resensitization (PIR) Group Experimental Treatment 1 Intervention

Subject to receive Physiologic Insulin Resensitization (PIR)

Group II: Standard of Care (SOC) Group Active Control 1 Intervention

Subjects will receive standard of care

Who Is Running the Clinical Trial?

Well Cell Global

Lead Sponsor