Cystic Fibrosis
Conditions
Keywords
cystic fibrosis, CF, CFRD, sitagliptin, incretins, GLP1, GIP, beta cell function, adolescents
Brief summary
This pilot study will be conducted in adolescents with cystic fibrosis (CF) without diabetes but with abnormal glucose tolerance, and will assess the effects of sitagliptin on glucose regulation. An oral glucose tolerance test (OGTT) and a mixed meal tolerance test (MMTT), will be performed at baseline and again \ 4 weeks after treatment with study drug. We will also look at blood sugars throughout the day using a continuous glucose monitor (CGM) before each time the MMTT/OGTT are performed. Several hormones that may affect the way the body regulates blood sugars will be measured in blood when the OGTT and MMTT are done. We will assess the effect this medicine has on blood sugars (using CGM) and the effect the medicine has on the hormones measured during the OGTT and MMTT.
Interventions
DRUGSitagliptin
Sponsors
Nemours Children's Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 20 Years
Healthy volunteers
No
Inclusion criteria
* Patients with CF between 13 and \<21 yrs old * Known impaired or indeterminate glucose tolerance (based on a prior OGTT) * No history of CFRD
Exclusion criteria
* Insulin use in the last two months * Acute pulmonary exacerbation / oral corticosteroid use in the last 6 weeks * History of pancreatitis in the last 12 months * Skin rashes or conditions that may affect CGM placement and wear * Pregnancy or intent on becoming pregnant * Patients on growth hormone therapy * Renal insufficiency with creatinine clearance \<50 ml/min (based on Schwartz formula)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response to sitagliptin | Change from baseline to ~4 weeks of study drug | Baseline and stimulated C-peptide levels (using mixed meal tolerance test) before and after treatment with sitagliptin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beta-cell function | Change from baseline to ~4 weeks of study drug | Beta-cell function will be measured using mixed meal tolerance tests (MMTT) and oral glucose tolerance tests (OGTT), assessing maximum concentration and area under the curve (AUC) of glucose, insulin and c-peptide for both OGTT and MMTT. |
| Continuous glucose monitoring (CGM) | change from baseline to ~4 weeks of study drug | Baseline and post-treatment changes in glycemic variability using CGM, including mean amplitude of glycemic excursion (MAGE), peak post-prandial blood sugars, and glucose area under the curve. |
Countries
United States
Outcome results
None listed