Glucose Metabolism in Cystic Fibrosis Related Diabetes (CFRD)

N/ANot Yet RecruitingNCT07102043

University of Alabama at Birmingham30 enrolled

Overview

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.

This is a mechanistic observational study. A physiological challenge of a single mixed meal tolerance test (MMTT) is administered, which will enable a comprehensive assessment of multiple parameters of glucose turnover, insulin secretion, insulin sensitivity and lipolysis in individuals with CFRD. The MMTT is the gold standard for measuring both insulin action and secretion simultaneously with glucose kinetics. The pilot 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). We plan to gather critical preliminary data on the following aspects of CFRD: 1. Abnormalities in specific components (basal vs. static vs. dynamic) of beta-cell function in CFRDF508del+ETI and in CFRD-ETI individuals. 2. Effects of ETI on components of beta cell function. 3. Effects of CFTR mutation and of CFTR modulators (CFRDF508del+ETI) on insulin sensitivity and post prandial glucose turnover in CFRD.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cystic Fibrosis Related Diabetes

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

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).

Time frame: Day 1 During the Mixed meal test

Secondary Outcomes

Post prandial glucose turnover

Post prandial glucose turnover is improved in CFRDF508del+ETI when compared to CFRD with a mutation not eligible to be on ETI (CFRD-ETI).

Time frame: Day 1 During the mixed meal test

Central Contacts

Rita Basu, MD

CONTACT

205-934-1200 rbasu@uabmc.edu

Ananda Basu, MD

CONTACT

205-934-1202 anandabasu@uabmc.edu

Data from ClinicalTrials.gov

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