SGLT2 Inhibitor Therapy in Cystic Fibrosis-related Diabetes

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.

Conditions

Cystic Fibrosis-related Diabetes, Cystic Fibrosis

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Study Overview

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Study Details

Study overview

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.

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

SGLT2 Inhibitor Therapy in Cystic Fibrosis-related Diabetes

Condition
Cystic Fibrosis-related Diabetes
Intervention / Treatment

-

Contacts and Locations

Minneapolis

University of Minnesota, Minneapolis, Minnesota, United States, 55455

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Adult subjects 18 years or older with CFRD and on insulin treatment
  • * BMI \>25 kg/m2
  • * 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.
  • * acute pulmonary exacerbation requiring IV antibiotics or systemic glucocorticoids within 4 weeks prior to baseline study procedures
  • * less than 12 weeks since start of a new CFTR corrector/modulator therapy
  • * type 1 diabetes
  • * Positive GAD 65 antibody or low fasting C-peptide (below the normal reference range of the lab)
  • * A history of diabetic ketoacidosis
  • * history of recurrent genital or urinary tract infections
  • * pregnancy or lactation
  • * prior solid organ transplant
  • * 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.
  • * chronic kidney disease (eGFR \< 60mL/min/1.73 m2)
  • * Hypersensitivity to empagliflozin or any excipients of Jardiance
  • * History of eating disorder
  • * Non-English speakers and those unable to read in English • Diminished capacity to consent (study staff will utilize the MacCAT-CR for assessment)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Amir Moheet,

Study Record Dates

2025-12-31