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Outcomes of Physiologic Insulin Resensitization (PIR) in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus

Randomized, Open Label Study to Examine the Outcomes of Physiologic Insulin Resensitization in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at the results of a treatment called physiologic insulin re-sensitization (PIR). It is for adults with long-term kidney disease at stage 3b, 4, or 5 and type 2 diabetes.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • You have had both stage 3b, 4, or 5 kidney disease and type 2 diabetes for at least 6 months before screening.
  • You may take diabetes pills or shots, including insulin or GLP-1 medicines.
  • The study doctor believes your treatment for any health complications has been suitable and stable for the past 6 months.
  • You can give informed consent, meaning you understand the study and agree to join. You can follow study steps and attend all visits, with help if needed.
  • If you are female and cannot become pregnant, you must be at least 50 and past menopause for at least 1 year, or have had surgery to tie both tubes, remove both ovaries, or remove the womb.
  • If you can become pregnant, you must have a negative blood pregnancy test at screening and use an accepted birth control method until at least 30 days after your last study treatment.

Who can't join

  • You had cancer treatment in the past 2 years, or you are receiving dialysis at screening, a treatment that filters your blood.
  • You are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed during the study.
  • In the past year, you used opioids or drugs that affect your mind without a prescription.
  • In the past 6 months, you had low blood sugar that needed urgent care, glucagon, osteocalcin, or glucose given by injection or vein, unless the study's medical monitor approves you.
  • In the past month, you joined a study testing an experimental drug or procedure, or a new way to control blood sugar using approved medicines.
  • At screening, you test positive for HIV, hepatitis B surface antigen, or hepatitis C virus in your blood.
  • Screening tests show hemoglobin below 8 g/dL, white blood cells below 2,000/µL, platelets below 50,000/µL, or albumin below 3 g/dL. These measure blood cells or blood proteins. You also cannot join if liver tests ALT, AST, or alkaline phosphatase are over 5 times the upper normal limit, or ALT or AST is over 2.5 times that limit with bilirubin over 2 times that limit.
  • The study doctor believes a mental health, behavior, thinking, or other health problem could make the study unsafe for you or keep you from following study rules.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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. * 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: o 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 Criteria: * 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. * 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 * Is nursing or is planning to nurse during the study. * Has at screening a positive test for HIV (4th gen. screen), HBsAg, or HCV viral load. * Has at screening, one or more of the following abnormal lab results: * Hb \<8 g/dL * WBC \<2,000/µL * Platelets \<50,000/µL * ALT, AST, or Alkaline Phosphatase \>5x ULN * ALT or AST \>2.5x ULN, and Total Bilirubin \>2x ULN * Serum albumin \<3 g/dL * 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. * Is on active dialysis at time of screening

Study sites (2)

AZ