Use of Empagliflozin to Treat Prediabetes

NCT05426525 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: OregonSU
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Overweight and Obesity; PreDiabetes; Prediabetic State

Outcome Measures

Primary Outcomes (1)

• 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

  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

  Oral glucose tolerance is measured before the start of the intervention (baseline) and during week 12 of the intervention.

• Fasting plasma glucose concentration

  Fasting plasma glucose is measured before the start of the intervention (baseline) and during week 13 of the intervention.

• Whole-body fat oxidation

  Whole-body fat oxidation is measured before the start of the intervention (baseline) and during week 13 of the intervention.

• Skeletal muscle insulin signaling

  Skeletal muscle insulin signaling is measured before the start of the intervention (baseline) and during week 13 of the intervention.

• Skeletal muscle lipids

  Skeletal muscle lipids are measured before the start of the intervention (baseline) and during week 13 of the intervention.

Study Arms (2)

Empagliflozin

EXPERIMENTAL

Participants will be provided 10-25mg empagliflozin per day for 13 weeks.

Drug: Empagliflozin

Multivitamin-Placebo

PLACEBO COMPARATOR

Participants will be provided 1 multivitamin-placebo per day for 13 weeks.

Drug: Multivitamin-Placebo

Interventions

Empagliflozin DRUG

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

Empagliflozin

Multivitamin-Placebo DRUG

Participants will take 1 multivitamin per day for 13 weeks.

Multivitamin-Placebo

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Samaritan Health Services: collaborator
• Oregon State University: lead

Study Sites (1)

Oregon State University

Corvallis, Oregon, 97331, United States

Location

MeSH Terms

Conditions

Prediabetic State; Overweight; Obesity

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sean A Newsom, Ph.D.

  Oregon State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Pills will be prepared and dispensed by a pharmacy to blind participants and investigators.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Kinesiology

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 22, 2022
• Study Start: October 13, 2022
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)