Type 2 Diabetes Mellitus(PIR)NCT07906470
Physiologic Insulin Resensitization (PIR) Treatment in Patients With a Diagnosis of Type 2 Diabetes Mellitus (T2DM)
A study testing Physiologic insulin resensitization (PIR) in people with Type 2 Diabetes Mellitus, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Physiologic insulin resensitization (PIR)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2026to 26 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is 18 or older (male or female)
- 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.
- 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.
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- Has the capacity or support to attend all required visits.
- 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
Who cannot join
- 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 non- prescriptive 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
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- An investigation method for glucose control using approved agents.
- Is nursing or is planning to nurse during the study.
- 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
- Weighs more than 450 lbs or has a waist circumference that exceeds the size of the MR bore when the coil is placed
- Has had recent iodine or barium-based contrast imaging
- Has an implanted device with metal incompatible with MR scanning, or the presence of any other metal in the body (such as shrapnel)
- Is unable to remain still for extended periods of time or to hold breath for 10 seconds
- Is claustrophobic.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Harper Basquill, RN, 205-659-7882, habasquill@uabmc.edu
Barbara Gower, PhD
About this study
Official title: Open Label Study to Examine the Outcomes of Physiologic Insulin Resensitization in Patients With Type 2 Diabetes Mellitus
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.
Read the detailed description
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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Physiologic insulin resensitization (PIR)
- Keywords
- Diabetes Mellitus, T2DM
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiologic insulin resensitization (PIR)Other
The PIR group will be required to undergo a three-hour infusion of insulin once or twice every week for weeks 0-24.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Cohort (SOC) | No intervention | Patients will continue standard of care treatment for Type 2 Diabetes Mellitus |
| Standard of Care (SOC) plus Physiologic Insulin Resensitizatioin (PIR) cohort | Experimental | Standard of care treatment for Type 2 diabetes mellitus in addition to a matched-pair design (matched for age, BMI, disease duration, A1c, medication) to receive physiologic insulin resensitization (PIR). Receives: Other: Physiologic insulin resensitization (PIR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
IVGTT (Intravenous Glucose Tolerance Test) is a medical research method used to measure how the body processes sugar and releases insulin.
Measured: 0, 12, and 24 weeks
Changes in percent body fat with dual-energy-X-ray absorption (DXA).
A DXA (dual-energy X-ray absorptiometry) scan is a fast, painless imaging test that uses low-dose X-rays to measure bone mineral density, strength, and body composition
Measured: 0, 12, and 24 weeks
Changes in ectopic fat (liver, visceral; fat fraction or square cm) using magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS).
Multiparametric magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) for ectopic fat.
Measured: 0, 12, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start26 Oct 2026 (estimated)
- Primary completion26 Oct 2027 (estimated)
- Study completion26 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Well Cell Global, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Barbara Gower, University of Alabama at Birmingham
- Investigators
- Barbara Gower, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906470
- Sponsor's protocol ID
- IRB-300017055
- Other IDs
- 1R44DK148354-01, Well Cell Global LLC
- Acronym
- (PIR)
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Study to Examine the Outcomes of Physiologic Insulin Resensitization in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07906470
- Acronym / sponsor ID
- (PIR) / IRB-300017055
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes Mellitus, T2DM
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Well Cell Global, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 26 Oct 2026 (estimated)
- Primary completion
- 26 Oct 2027 (estimated)
- Study completion
- 26 Oct 2028 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Cohort (SOC) | No intervention | –Patients will continue standard of care treatment for Type 2 Diabetes Mellitus |
| Standard of Care (SOC) plus Physiologic Insulin Resensitizatioin (PIR) cohort | Experimental | Other: Physiologic insulin resensitization (PIR)Standard of care treatment for Type 2 diabetes mellitus in addition to a matched-pair design (matched for age, BMI, disease duration, A1c, medication) to receive physiologic insulin resensitization (PIR). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Is 18 or older (male or female)
- 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.
- 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:
- If female, the subject must meet either of the following sets of conditions:
Key exclusion criteria (15 listed)
- 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 non- prescriptive 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiologic insulin resensitization (PIR)The PIR group will be required to undergo a three-hour infusion of insulin once or twice every week for weeks 0-24. | Other | Standard of Care (SOC) plus Physiologic Insulin Resensitizatioin (PIR) cohort |
Primary outcome
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.
Time frame: 0, 12, and 24 weeks
IVGTT (Intravenous Glucose Tolerance Test) is a medical research method used to measure how the body processes sugar and releases insulin.
Changes in percent body fat with dual-energy-X-ray absorption (DXA).
Time frame: 0, 12, and 24 weeks
A DXA (dual-energy X-ray absorptiometry) scan is a fast, painless imaging test that uses low-dose X-rays to measure bone mineral density, strength, and body composition
Changes in ectopic fat (liver, visceral; fat fraction or square cm) using magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS).
Time frame: 0, 12, and 24 weeks
Multiparametric magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) for ectopic fat.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Barbara Gower, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiologic insulin resensitization (PIR) in people with Type 2 Diabetes Mellitus, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Harper Basquill, RN (205-659-7882, habasquill@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 0, 12, and 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.