Hormonal Responses to a Mixed Meal in People With Cystic Fibrosis

NCT06163482 | Recruiting Early Phase 1

• 1 other identifier: 2022-0593
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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

Keywords

diabetes; cystic fibrosis

Outcome Measures

Primary Outcomes (4)

• Concentration of Insulin

  human plasma

  Up to 3 hours

• Concentration of Glucagon

  human plasma

  Up to 3 hours

• Concentration of Somatostatin

  human plasma

  Up to 3 hours

• Concentration of Glucose

  human plasma

  Up to 3 hours

Secondary Outcomes (3)

• Concentration of GLP-1

  Up to 3 hours

• Concentration of GIP

  Up to 3 hours

• Concentration of fatty acids

  Up to 3 hours

Study Arms (4)

Healthy controls

EXPERIMENTAL

No cystic fibrosis (CF)

Other: Mixed meal

Pancreatic sufficient CF

EXPERIMENTAL

cystic fibrosis, but not pancreatic insufficient

Other: Mixed meal

Pancreatic insufficient CF

EXPERIMENTAL

cystic fibrosis and pancreatic insufficient

Other: Mixed meal

CF-related diabetes

EXPERIMENTAL

cystic fibrosis and diabetes

Other: Mixed meal

Interventions

Mixed meal OTHER

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

CF-related diabetes; Healthy controls; Pancreatic insufficient CF; Pancreatic sufficient CF

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267-0547, United States

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jason Winnick, PhD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Winnick, PhD

CONTACT

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

Shana Warner, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Four groups of people will be studied, using a cross-sectional design. Groups will include 1) healthy control subjects; 2) pancreatic sufficient people with cystic fibrosis; 3) pancreatic insufficient people with cystic fibrosis and 4) people with cystic fibrosis related diabetes. Subjects from each group will have their hormonal responses to the same mixed meal assessed.

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 11, 2023
• Study Start: March 28, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)