ACTIVE_NOT_RECRUITING

SGLT2 Inhibitor Therapy in Cystic Fibrosis-related Diabetes

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Conditions

Cystic Fibrosis-related DiabetesCystic FibrosisCFRDcystic fibrosis related diabetesempagliflozin

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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

This will be a placebo-controlled, randomized, double blind, crossover study with a 4 week wash out period. Collect pilot data on the safety, tolerability, and feasibility of empagliflozin therapy in overweight/obese patients with CFRD to support a future larger randomized controlled trial.

Official Title

Empagliflozin in CFRD: Efficacy and Safety of SGLT2 Inhibitor Therapy in Overweight and Obese Subjects With Cystic Fibrosis-related Diabetes: a Pilot Study

Quick Facts

Study Start:2023-12-30
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06149793

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult subjects 18 years or older with CFRD and on insulin treatment
  2. * BMI \>25 kg/m2
  3. * A participant who is capable of becoming pregnant must agree to take precautions that are effective in preventing pregnancy throughout this study. These methods could include one of the following 1. Complete abstinence from sexual intercourse; 2. Tubal ligation; 3. Use combination of two forms of contraception during the study including, oral, injectable, or implanted hormonal contraceptives, intrauterine device or barrier method.
  1. * acute pulmonary exacerbation requiring IV antibiotics or systemic glucocorticoids within 4 weeks prior to baseline study procedures
  2. * less than 12 weeks since start of a new CFTR corrector/modulator therapy
  3. * type 1 diabetes
  4. * Positive GAD 65 antibody or low fasting C-peptide (below the normal reference range of the lab)
  5. * A history of diabetic ketoacidosis
  6. * history of recurrent genital or urinary tract infections
  7. * pregnancy or lactation
  8. * prior solid organ transplant
  9. * Chronic liver disease (based on problem list in medical records or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 times elevated above the upper limit of normal.
  10. * chronic kidney disease (eGFR \< 60mL/min/1.73 m2)
  11. * Hypersensitivity to empagliflozin or any excipients of Jardiance
  12. * History of eating disorder
  13. * Non-English speakers and those unable to read in English • Diminished capacity to consent (study staff will utilize the MacCAT-CR for assessment)

Contacts and Locations

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: University of Minnesota

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 Date2023-12-30
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-12-30
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • CFRD
  • cystic fibrosis
  • cystic fibrosis related diabetes
  • empagliflozin

Additional Relevant MeSH Terms

  • Cystic Fibrosis-related Diabetes
  • Cystic Fibrosis