Glucose Metabolism in CFRD: Exploring the Role of CFTR Modulators in Metabolic Dysfunction
University of Alabama at Birmingham
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.
Description
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…
Eligibility
- Age range
- 21–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Diagnosis of Cystic Fibrosis Related Diabetes (CFRD) 2. Age 21-75 years at time of consent 3. BMI 19-50 kg/m2 (In Asians BMI is \~ 2 points lower for comparison so it is 17-48 kg/m2) 4. Creatinine ≤ 1.4 mg/dl in women and ≤ 1.5 mg/dl in men 5. HbA1c ≤ 11% lifestyle treatment or mono/combination therapy with oral hypoglycemic agents (e.g. metformin or sulphonylurea or SGLT2i) and preferably on insulin pump therapy (i.e., SAP, HCL) with or without CGM will be recruited. However, use of MDI (Multiple Daily Injections) of insulin, i.e., on basal-bolus insulin therapy will a…
Location
- University of Alabama at BirminghamBirmingham, Alabama