Recruiting

Observational Study

Sponsor:

University of Cincinnati

Code:

NCT06163482

Conditions

Cystic Fibrosis

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Mixed meal

Study Details

Brief summary:

In this exploratory study, the hormonal responses to a mixed meal will be examined in people with cystic fibrosis. The aim of this study is to find correlates with impaired glucose tolerance that is associated with this population.

Conditions

Cystic Fibrosis

Study ID

NCT06163482

Start date

Mar 28, 2023

Status verified date

Aug, 2026

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Diagnosed with cystic fibrosis
  • Aged 18 to 45 years
  • Males and females of any race and ethnicity
  • Receiving highly effective CFTR modular therapy

Exclusion Criteria:

  • Transplant recipient
  • Acute lung function decline or exacerbation within the last 3 months
  • Use of systemic glucocorticoids
  • Pregnancy
  • Known liver disease that would be expected to significantly impact metabolic variable as interpreted by a study doctor
  • The presence of any other disease or condition, as interpreted by any one of the study doctors, that would be expected to confound the responses to liquid mixed meal or make participation in the study dangerous to the individual
  • People who are cognitively impaired
  • People who do not speak English
  • For CFRD patients, a daily insulin requirement that exceeds 0.8 U/kg/day
  • Any prior history of diabetic ketoacidosis.

Study Design

Enrollment

61 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy controls

No cystic fibrosis (CF)

Pancreatic sufficient CF

cystic fibrosis, but not pancreatic insufficient

Pancreatic insufficient CF

cystic fibrosis and pancreatic insufficient

CF-related diabetes

cystic fibrosis and diabetes

Interventions

Mixed meal

Each individual will ingest 5 mL/kg of Boost energy drink.

Primary outcome measure

  • Concentration of Insulin [ Time Frame: Up to 3 hours ]
  • Concentration of Glucagon [ Time Frame: Up to 3 hours ]
  • Concentration of Somatostatin [ Time Frame: Up to 3 hours ]
  • Concentration of Glucose [ Time Frame: Up to 3 hours ]

Central Contacts and Locations

Central contacts

Jason Winnick, PhD

513-558-4437jason.winnick@uc.edu

Shana Warner, PhD

513-558-5545warners3@ucmail.uc.edu

Locations

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267-0547

Contacts

Jason Winnick, PhD

513-558-4437jason.winnick@uc.edu

More Information

Sponsor

University of Cincinnati

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Keywords

  • diabetes
  • cystic fibrosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2026-08-25.