ACTIVE_NOT_RECRUITING

Use of Empagliflozin to Treat Prediabetes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Use of Empagliflozin to Treat Prediabetes - a Randomized, Double-blind, Placebo-controlled 13-week Intervention Trial

Quick Facts

Study Start:2022-10-13
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05426525

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 59 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * BMI 26-45 kg/m2
  2. * Weight stable (± 10 lbs in previous 3 months)
  3. * Fasting blood glucose \<126 mg/dL or HbA1c \<6.5% (\<48mmol/mol)
  1. * Regular moderate-vigorous exercise (≥30 min/session on ≥2 days per week)
  2. * Pregnancy, planning to become pregnant or nursing
  3. * Lidocaine allergy
  4. * Current or recent smoking or nicotine use (≤ 1-year abstention)
  5. * Medications including glucose lowering medications and supplements (SGLT2 inhibitors, GLP1 agonists, sulfonylurea, insulin, TZDs); mono-amine oxidase inhibitors; beta-blockers; diuretics
  6. * 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)
  7. * 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).
  8. * Contraindications/precautions for empagliflozin (impaired renal function (EGR\<60), history of: empagliflozin hypersensitivity, ketoacidosis, hypotension, recurring urinary tract or genital mycotic infections, amputation)

Contacts and Locations

Principal Investigator

Sean A Newsom, Ph.D.
PRINCIPAL_INVESTIGATOR
Oregon State University

Study Locations (Sites)

Oregon State University
Corvallis, Oregon, 97331
United States

Collaborators and Investigators

Sponsor: Oregon State University

  • Sean A Newsom, Ph.D., PRINCIPAL_INVESTIGATOR, Oregon State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-13
Study Completion Date2026-12

Study Record Updates

Study Start Date2022-10-13
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

  • PreDiabetes
  • Prediabetic State
  • Overweight and Obesity