An interventional study of Physiologic insulin resensitization (PIR) in Type 2 Diabetes Mellitus, sponsored by University of Alabama at Birmingham. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
Among 31 studies in Diabetes Mellitus, Type 2 by University of Alabama at Birmingham — 8 open to participants now, 10 under way, 1 of them phase 3. Diabetes Mellitus, Type 2 · University of Alabama at Birmingham.
Among the 31 studies in Diabetes Mellitus, Type 2 by University of Alabama at Birmingham, this one is the 18th largest by planned enrollment of the 30 interventional ones that give a count, is one of 5 that started in 2026, is one of 26 with no phase, and was the 31st registered.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →8 of the 31 studies in Diabetes Mellitus, Type 2 by University of Alabama at Birmingham are open now, in 1 country. Each count lists the studies.
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →31 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 5 started in 2026.
Median enrollment 84 across the 30 interventional studies, 360 across the 1 observational. Of the 20 that completed or were terminated, 6 (30%) have results posted.
University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
4 of the studies in Diabetes Mellitus, Type 2 by University of Alabama at Birmingham that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07220213University of Alabama at BirminghamFELLAShip to Better Health | 2027-01-01 |
| NCT06312553University of Alabama at BirminghamRemotely Delivered Mindfulness-Based Diabetes Education | 2027-06-30 |
| NCT06902077University of Alabama at BirminghamA Low-Carb Approach to Treat Type 2 Diabetes in Pediatric Patients | 2027-08-31 |
| NCT07906470University of Alabama at BirminghamPhysiologic Insulin Resensitization (PIR) Treatment in Patients With a Diagnosis of Type 2 Diabetes Mellitus (T2DM) | 2027-10-26 |
Among the 31 studies in Diabetes Mellitus, Type 2 by University of Alabama at Birmingham, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Has within the past one (1) month participated in a clinical study involving either of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will continue standard of care treatment for Type 2 Diabetes Mellitus
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).
Other: 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.
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.
Time frame: 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
Time frame: 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.
Time frame: 0, 12, and 24 weeks
Plan to share: Yes
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 12 months is below that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham →