A Phase 4 interventional study of Empagliflozin and Multivitamin-Placebo in PreDiabetes, Prediabetic State and Overweight and Obesity, sponsored by Oregon State University. Completed at 1 site in United States. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Oregon State University · Phase 4, Interventional, and Basic science
Among 390 studies in Prediabetic State with a site in United States — 84 open to participants now, 108 under way, 2 of them phase 3. Prediabetic State · United States.
Among the 390 studies in Prediabetic State with a site in United States, this one is the 158th largest by enrollment of the 362 interventional ones that give a count, is one of 32 that started in 2022, is one of 16 in phase 4, and was the 249th registered.
918 studies on the registry are indexed under Prediabetic State; 232 are open to participants now.
Browse Prediabetic State studies →84 of the 390 studies in Prediabetic State with a site in United States are open now. Recruiting first, the newest first:
Rahul Sachdeva · Sites in United States
University of South Florida · Sites in United States
St. Louis University · Sites in United States
Morehouse School of Medicine · Sites in United States
Penn State University · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 145 Prediabetic State studies recruiting now, 51 (35%) set no upper age limit and 84 (58%) stop at 75 or younger; 12 take children under 18; 54 take healthy volunteers.
This study: 18 Years to 59 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
390 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 22 · Phase 2 25 · Phase 3 16 · Phase 4 16
First in 1996; this study’s year is marked. 32 started in 2022.
This study's enrollment of 60 is close to the median of 62 across 762 interventional studies indexed under Prediabetic State.
Median enrollment 54 across the 362 interventional studies, 188 across the 28 observational. Of the 257 that completed or were terminated, 89 (35%) have results posted.
This tab as a report to print or save as PDF → With an account.
35 of 390 have an industry lead sponsor. The 10 most frequent:
Oregon State University is the lead sponsor of 38 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.
Oregon State University has 1 study filed under Prediabetic State — fewer than ten, so there is no comparison to draw.
45 of the studies in Prediabetic State with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06995378University of California, Los AngelesStudy EHR Risk Stratification Tools | 2026-11 |
| NCT05165706Stanford UniversityLongitudinal Multi-Omic Profiles to Reveal Mechanisms of Obesity-Mediated Insulin Resistance | 2026-11-30 |
| NCT07450118University of DelawareNested Pilot Study Comparing Two Treatments to Reduce Type 2 Diabetes Risk in At-Risk Delawareans | 2026-12 |
| NCT05067621Yale UniversitySemaglutide Effects in Obese Youth With Prediabetes/New Onset Type 2 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease | 2026-12 |
| NCT07868432Tufts UniversityGlycemic Impact of NNS Via the Gut Microbiome | 2026-12 |
Among the 390 studies in Prediabetic State with a site in United States, from their registry updates:
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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).
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.
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.
Exclusion Criteria:
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be provided 10-25mg empagliflozin per day for 13 weeks.
Drug: Empagliflozin
Participants will be provided 1 multivitamin-placebo per day for 13 weeks.
Drug: Multivitamin-Placebo
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.
Also known as: Jardiance
Participants will take 1 multivitamin per day for 13 weeks.
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
Time frame: Insulin-stimulated glucose disposal is measured before the start of the intervention (baseline) and during week 13 of the intervention.
Oral glucose tolerance
The change in blood glucose concentration in response to a 75g glucose beverage
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
The change in 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
Indirect calorimetry will be used to determine the change in whole-body rate of fat oxidation during basal and insulin-stimulated conditions
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
Immunoblotting to determine the change in activation of insulin signaling proteins in skeletal muscle collected at basal and during insulin-stimulated conditions
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
Mass spectrometry lipidomic analysis of skeletal muscle to determine changes in muscle lipid content
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
Changes in skeletal muscle mitochondrial respiratory capacity measured using high-resolution respirometry
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
Immunoblotting to determine changes in activation of AMPK and related signaling proteins pathways
Time frame: Skeletal muscle energetic stress is measured before the start of the intervention (baseline) and during week 13 of the intervention.
Plan to share: 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.
No publications or documents are linked to this record.
Ran from Oct 2022 to primary completion in Apr 2026, 42 months.
Of 30 phase 4 interventional studies under Prediabetic State, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 47. This study's 42 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Empagliflozin
Oregon State University