Glucose Metabolism in Cystic Fibrosis Related Diabetes (CFRD)

NCT07102043 | Not Yet Recruiting DMC

• 2 other identifiers: IRB300014949P30DK072482
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to test whether use of CFTR modulators (ETI) improves fasting and post prandial glycemia by enhancing disposition index (DI) in individuals with CFRD with CFTR +ve mutation (at least one copy of F508del) on CFTR modulator (ETI) therapy (CFRDF508del+ETI). CFRD with a mutation that is not eligible for modulator therapy (CFRD-ETI) will be the control group.

Conditions

Cystic Fibrosis Related Diabetes

Keywords

Cystic Fibrosis Related Diabetes; cystic fibrosis transmembrane conductance regulator (CFTR); CFTR modulators; Elexacaftor/ tezacaftor/ivacaftor or ETI

Outcome Measures

Primary Outcomes (1)

• Disposition Index in CFRD

  Disposition Index (DI - β-cell responsivity appropriate to the degree of insulin resistance) is higher in CFRDF508del+ETI when compared to CFRD with a mutation not eligible to be on ETI (CFRD-ETI).

  Day 1 During the Mixed meal test

Secondary Outcomes (1)

• Post prandial glucose turnover

  Day 1 During the mixed meal test

Study Arms (2)

CFRD F508del +ETI

CFRD with at least one copy of F508del currently on elexacaftor/tezacaftor/ivacaftor (CFRDF508del+ETI),

CFRD-ETI

CFRD with a mutation that is not eligible for modulator therapy (CFRD-ETI).

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with Cystic Fibrosis related Diabetes (CFRD)

You may qualify if:

• Individuals who have at least one copy of the F508 deletion and are on ETI medications and individuals who have a different mutation and are not eligible for ETI medications
• Age 21-75 years at time of consent
• BMI 19-50 kg/m2 (In Asians BMI is \~ 2 points lower for comparison so it is 17-48 kg/m2)
• Creatinine ≤ 1.4 mg/dl in women and ≤ 1.5 mg/dl in men
• HbA1c ≤ 11% lifestyle treatment or mono/combination therapy with oral hypoglycemic agents (e.g. metformin or sulphonylurea or SGLT2i) and/or insulin.
• Willing to be at a stable weight for duration of the study.
• An understanding of and willingness to follow the protocol and sign the informed consent

You may not qualify if:

• Debilitating chronic disease
• Anemia \<10 gm/dL in females and \<11.0 gm/dL in males
• Symptoms of undiagnosed illness on history/exam
• Abuse of alcohol or recreational drugs
• Pregnancy
• Active hepatic disease
• Current use of the following drugs and supplements: corticosteroids, benzodiazepines, opiates, barbiturates, anticoagulant therapy
• Any other medication that the investigator believes is a contraindication to the subject's participation

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 352294, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Participant biospecimen will be retained until all analysis for outcome measures are complete and results published. DNA will not be extracted retained samples.

Study Officials

• Rita Basu, MD

  UAB Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rita Basu, MD

CONTACT

205-934-1200; rbasu@uabmc.edu

Ananda Basu, MD

CONTACT

205-934-1202; anandabasu@uabmc.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endowed Professor of Diabetes Science; Medical Director, Office of Human Research Protection Program, and Chair of the Institutional Review Board

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: August 3, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)