At a glance
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EnVision CF Multicenter Study of Glucose Tolerance in Cystic Fibrosis
In Brief
A clinical study evaluating Oral glucose tolerance test, Continuous glucose monitoring, and 1 other intervention for Cystic Fibrosis-related Diabetes. Completed, enrolled 317 participants across 4 sites.
Detailed Summary
Cystic Fibrosis Related Diabetes has been identified by the CF community as one of the top ten priorities for CF research. In CF clinical decline due to dysglycemia begins early, prior to diagnosis of diabetes and increases mortality from pulmonary disease. There is presently no way to determine who, of those with dysglycemia, will experience clinical compromise. However, the CF Center in Milan has found that measurable age- and sex-dependent variables on oral glucose tolerance testing (OGTT) predict β-cell failure-the primary driver of decline in CF. the investigators propose a multi-center trial to develop nomograms of age and sex dependent reference values for OGTT-derived measures including glucose, insulin, c-peptide, and the resultant OGTT-derived estimates of β-cell function, β cell sensitivity to glucose, and oral glucose insulin sensitivity (OGIS) and to determine correlation of these with clinical status (FEV-1, BMI z score, number of pulmonary exacerbations over the past 12 months). In a subset of the cohort the investigators will perform additional studies to determine possible mechanisms driving abnormal β cell function, including the role of lean body mass (as measured by DXA), impact of incretin (GLP-1, GIP) and islet hormones (glucagon, pancreatic polypeptide) on β cell function and the relationship of reactive hypoglycemia and catecholamine responses to β cell function, as well as the relationship of β cell sensitivity to glucose as determined by our model to abnormalities in blood glucose found in a period of free living after the study (determined by continuous glucose monitoring measures (Peak glucose, time spent \>200 mg/dl, standard deviation). the investigators will also develop a biobank of stored samples to allow expansion to the full cohort if warranted and to enable future studies of dysglycemia and diabetes in CF. the investigator's eventual goal is utilization of the nomograms to determine the minimum number of measures to accurately predict risk for clinical decline from dysglycemia in CF.
Study Details
Timeline
Interventions
oral glucose solution is given by mouth, blood is drawn prior to the administration of the oral glucose beverage and then at timed intervals afterward. This is the standard test to diagnosis cystic fibrosis related diabetes mellitus. However, this study will have more time points than standard screening for cystic fibrosis related diabetes mellitus
a device is placed on the subject's arm that continuously monitors subcutaneous glucose levels for up to 10 days
low dose x-rays are used to measure the subject's bone density. This is the standard test to diagnose osteoporosis