PreDiabetesPhase 4NCT05426525
Use of Empagliflozin to Treat Prediabetes
A Phase 4 study testing Empagliflozin in people with PreDiabetes and Prediabetic State, run by Oregon State University at 1 site in United States.
Trial summary
The overall purpose of this study is to identify how empagliflozin (a drug commonly used to treat type 2 diabetes) impacts skeletal muscle metabolic health among adults with prediabetes. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- PreDiabetes, Prediabetic State, Overweight and Obesity
- What is being tested?
- Empagliflozin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2022to 20 Aug 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI 26-45 kg/m2
- Weight stable (± 10 lbs in previous 3 months)
- Fasting blood glucose <126 mg/dL or HbA1c <6.5% (<48mmol/mol)
Who cannot join
- Regular moderate-vigorous exercise (≥30 min/session on ≥2 days per week)
- Pregnancy, planning to become pregnant or nursing
- Lidocaine allergy
- Current or recent smoking or nicotine use (≤ 1-year abstention)
- Medications including glucose lowering medications and supplements (SGLT2 inhibitors, GLP1 agonists, sulfonylurea, insulin, TZDs); mono-amine oxidase inhibitors; beta-blockers; diuretics
- Major metabolic or cardiovascular conditions (e.g., type 1 diabetes, Crohn's disease, untreated hypo- or hyperthyroid, cancer, coronary artery disease, tachycardia, prior bariatric surgery, peripheral vascular disease, liver diseases (e.g., cirrhosis)
- Diagnosed type 2 diabetes. In absence of diagnosis, two separate samples with test results of fasting blood glucose ≥126 mg/dL or HbA1c ≥6.5% (48 mmol/mol).
- Contraindications/precautions for empagliflozin (impaired renal function (EGR<60), history of: empagliflozin hypersensitivity, ketoacidosis, hypotension, recurring urinary tract or genital mycotic infections, amputation)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Empagliflozin to Treat Prediabetes - a Randomized, Double-blind, Placebo-controlled 13-week Intervention Trial
The overall purpose of this study is to identify how empagliflozin (a drug commonly used to treat type 2 diabetes) impacts skeletal muscle metabolic health among adults with prediabetes. Our aims are to: 1) Test the ability of empagliflozin to improve regulation of glucose metabolism (i.e., blood sugar) among overweight and obese individuals at risk for diabetes, and 2) Identify mechanisms to explain how empagliflozin may improve skeletal muscle glucose metabolism. We hypothesize empagliflozin will improve regulation of glucose metabolism due to changes in whole-body and skeletal muscle metabolism (e.g., increased rates of whole-body fat oxidation, evidence of impaired skeletal muscle mitochondrial respiratory function and increased energetic stress, lower accumulation of skeletal muscle lipids and improved skeletal muscle insulin signaling compared with placebo treatment).
Read the detailed description
The overall study design is a 13-week, double-blind, placebo-controlled intervention trial, testing the ability of empagliflozin to improve glucose metabolism among overweight and obese individuals at risk for diabetes (compared with a multivitamin-placebo). The study involves metabolic testing before and during the intervention to identify changes in outcomes as a function of the intervention and to ensure participant safety. The study involves 9 visits to the Samaritan Athletic Medicine Center on the campus of Oregon State University in Corvallis, Oregon. Full completion of the study is anticipated to take ~4 months. The project is being completed in collaboration with physicians at Samaritan Health Services.
- Conditions
- PreDiabetes, Prediabetic State, Overweight and Obesity
- Being tested
- Empagliflozin, Multivitamin-Placebo
- Medical subject headings
- Prediabetic State, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
Also called Jardiance
Participants will take 10mg empagliflozin per day for 2 weeks. Absent contraindications, dosing will be increased to 25 mg empagliflozin per day for the next 11 weeks.
Multivitamin-PlaceboDrug
Participants will take 1 multivitamin per day for 13 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin | Experimental | Participants will be provided 10-25mg empagliflozin per day for 13 weeks. Receives: Drug: Empagliflozin |
| Multivitamin-Placebo | Placebo comparator | Participants will be provided 1 multivitamin-placebo per day for 13 weeks. Receives: Drug: Multivitamin-Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin-stimulated glucose disposal
The glucose infusion rate to maintain glycemia during insulin clamp, using plasma enrichment of glucose isotope tracer to determine changes in rates of insulin-stimulated glucose disposal
Measured: Insulin-stimulated glucose disposal is measured before the start of the intervention (baseline) and during week 13 of the intervention.
Secondary outcomes (7)
Oral glucose tolerance
The change in blood glucose concentration in response to a 75g glucose beverage
Measured: Oral glucose tolerance is measured before the start of the intervention (baseline) and during week 12 of the intervention.
Fasting plasma glucose concentration
The change in fasting plasma glucose concentration
Measured: Fasting plasma glucose is measured before the start of the intervention (baseline) and during week 13 of the intervention.
Whole-body fat oxidation
Indirect calorimetry will be used to determine the change in whole-body rate of fat oxidation during basal and insulin-stimulated conditions
Measured: Whole-body fat oxidation is measured before the start of the intervention (baseline) and during week 13 of the intervention.
Skeletal muscle insulin signaling
Immunoblotting to determine the change in activation of insulin signaling proteins in skeletal muscle collected at basal and during insulin-stimulated conditions
Measured: Skeletal muscle insulin signaling is measured before the start of the intervention (baseline) and during week 13 of the intervention.
Skeletal muscle lipids
Mass spectrometry lipidomic analysis of skeletal muscle to determine changes in muscle lipid content
Measured: Skeletal muscle lipids are measured before the start of the intervention (baseline) and during week 13 of the intervention.
Skeletal muscle mitochondrial respiratory function
Changes in skeletal muscle mitochondrial respiratory capacity measured using high-resolution respirometry
Measured: Skeletal muscle mitochondrial respiratory function is measured before the start of the intervention (baseline) and during week 13 of the intervention.
Skeletal muscle energetic stress
Immunoblotting to determine changes in activation of AMPK and related signaling proteins pathways
Measured: Skeletal muscle energetic stress is measured before the start of the intervention (baseline) and during week 13 of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start13 Oct 2022
- Primary completion30 Apr 2026
- Study completion20 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon State University
- Sponsor type
- University, hospital or other
- Collaborators
- Samaritan Health Services
- Responsible party
- Principal investigator, Sean Newsom, Oregon State University
- Investigators
- Sean A Newsom, Ph.D., Principal investigator, Oregon State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426525
- Sponsor's protocol ID
- OregonSU
- Status last verified
- Aug 2026
- First submitted
- 8 Jun 2022
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The current study is a pilot and feasibility project. IPD will not be made publicly available, save for publication and reporting requirements. Individual requests for data will be addressed by the Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Empagliflozin to Treat Prediabetes - a Randomized, Double-blind, Placebo-controlled 13-week Intervention Trial
- ClinicalTrials.gov ID
- NCT05426525
- Acronym / sponsor ID
- OregonSU
- Conditions
- PreDiabetes, Prediabetic State, Overweight and Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Oregon State UniversityUniversity, hospital or other
- Collaborators
- Samaritan Health Services
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 20 Aug 2026 (actual)
- First posted
- 22 Jun 2022 (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 overall purpose of this study is to identify how empagliflozin (a drug commonly used to treat type 2 diabetes) impacts skeletal muscle metabolic health among adults with prediabetes. Our aims are to: 1) Test the ability of empagliflozin to improve regulation of glucose metabolism (i.e., blood sugar) among overweight and obese individuals at risk for diabetes, and 2) Identify mechanisms to explain how empagliflozin may improve skeletal muscle glucose metabolism. We hypothesize empagliflozin will improve regulation of glucose metabolism due to changes in whole-body and skeletal muscle metabolism (e.g., increased rates of whole-body fat oxidation, evidence of impaired skeletal muscle mitochondrial respiratory function and increased energetic stress, lower accumulation of skeletal muscle lipids and improved skeletal muscle insulin signaling compared with placebo treatment).
Detailed description
The overall study design is a 13-week, double-blind, placebo-controlled intervention trial, testing the ability of empagliflozin to improve glucose metabolism among overweight and obese individuals at risk for diabetes (compared with a multivitamin-placebo). The study involves metabolic testing before and during the intervention to identify changes in outcomes as a function of the intervention and to ensure participant safety. The study involves 9 visits to the Samaritan Athletic Medicine Center on the campus of Oregon State University in Corvallis, Oregon. Full completion of the study is anticipated to take ~4 months. The project is being completed in collaboration with physicians at Samaritan Health Services.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin | Experimental | Drug: EmpagliflozinParticipants will be provided 10-25mg empagliflozin per day for 13 weeks. |
| Multivitamin-Placebo | Placebo comparator | Drug: Multivitamin-PlaceboParticipants will be provided 1 multivitamin-placebo per day for 13 weeks. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI 26-45 kg/m2
- Weight stable (± 10 lbs in previous 3 months)
- Fasting blood glucose <126 mg/dL or HbA1c <6.5% (<48mmol/mol)
Key exclusion criteria (8 listed)
- Regular moderate-vigorous exercise (≥30 min/session on ≥2 days per week)
- Pregnancy, planning to become pregnant or nursing
- Lidocaine allergy
- Current or recent smoking or nicotine use (≤ 1-year abstention)
- Medications including glucose lowering medications and supplements (SGLT2 inhibitors, GLP1 agonists, sulfonylurea, insulin, TZDs); mono-amine oxidase inhibitors; beta-blockers; diuretics
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 |
|---|---|---|
| EmpagliflozinAlso: JardianceParticipants will take 10mg empagliflozin per day for 2 weeks. Absent contraindications, dosing will be increased to 25 mg empagliflozin per day for the next 11 weeks. | Drug | Empagliflozin |
| Multivitamin-PlaceboParticipants will take 1 multivitamin per day for 13 weeks. | Drug | Multivitamin-Placebo |
Primary outcome
Insulin-stimulated glucose disposal
Time frame: Insulin-stimulated glucose disposal is measured before the start of the intervention (baseline) and during week 13 of the intervention.
The glucose infusion rate to maintain glycemia during insulin clamp, using plasma enrichment of glucose isotope tracer to determine changes in rates of insulin-stimulated glucose disposal
7 secondary outcomes
Oral glucose tolerance
Time frame: Oral glucose tolerance is measured before the start of the intervention (baseline) and during week 12 of the intervention.
Fasting plasma glucose concentration
Time frame: Fasting plasma glucose is measured before the start of the intervention (baseline) and during week 13 of the intervention.
Whole-body fat oxidation
Time frame: Whole-body fat oxidation is measured before the start of the intervention (baseline) and during week 13 of the intervention.
Skeletal muscle insulin signaling
Time frame: Skeletal muscle insulin signaling is measured before the start of the intervention (baseline) and during week 13 of the intervention.
Skeletal muscle lipids
Time frame: Skeletal muscle lipids are measured before the start of the intervention (baseline) and during week 13 of the intervention.
Skeletal muscle mitochondrial respiratory function
Time frame: Skeletal muscle mitochondrial respiratory function is measured before the start of the intervention (baseline) and during week 13 of the intervention.
Skeletal muscle energetic stress
Time frame: Skeletal muscle energetic stress is measured before the start of the intervention (baseline) and during week 13 of the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No. The current study is a pilot and feasibility project. IPD will not be made publicly available, save for publication and reporting requirements. Individual requests for data will be addressed by the Principal Investigator.
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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. This study is not recruiting at the moment.
Sean A Newsom, Ph.D. principal investigator
Oregon State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Empagliflozin in people with PreDiabetes and Prediabetic State, run by Oregon State University 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 24 Aug 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin-stimulated glucose disposal (time frame: Insulin-stimulated glucose disposal is measured before the start of the intervention (baseline) and during week 13 of the intervention.). 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 24 Aug 2026.