Diabetes
Conditions
Keywords
Diabetes, Adolescents, Cystic Fibrosis, Insulin, Repaglinide
Brief summary
This study will test the hypothesis that oral repaglinide is equivalent to insulin in the treatment of new-onset CFRD in adolescents. In addition, successful treatment of CFRD with repaglinide will improve nutritional status, ameliorate declines in pulmonary function, and will not have a negative impact upon quality of life.
Detailed description
This study will test the hypothesis that oral repaglinide is equivalent to insulin in the treatment of new-onset CFRD. This hypothesis will be tested using the following aims: Specific Aim 1: To determine the effect of three months of repaglinide and insulin treatment upon blood glucose (BG) and insulin excursion during an oral glucose tolerance test. Specific Aim 2: To determine the effect of three months of repaglinide and insulin treatment upon BG as measured by continuous glucose monitoring, fasting BG, 2-hour post-prandial BG, hemoglobin A1C, and serum fructosamine. Secondary Aim 1: To determine the effect of three months of repaglinide and insulin treatment upon weight, body mass index, and lean body mass in adolescents with new-onset CFRD. Secondary Aim 2: To determine the effect of three months of repaglinide and insulin treatment upon pulmonary function in adolescents with new-onset CFRD. Secondary Aim 3: To determine the effect of three months of repaglinide and insulin treatment upon quality of life in new-onset CFRD.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
Cystic Fibrosis, Blood glucose concerning for diabetes -
Exclusion criteria
Known Cystic Fibrosis-Related Diabetes, Liver Disease, FEV1\<40% \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum fructosamine | — |
| blood glucose | — |
| insulin excursion during oral glucose tolerance test | — |
| fasting blood glucose | — |
| 2-hour post-prandial blood glucose | — |
| hemoglobin A1C | — |
Secondary
| Measure | Time frame |
|---|---|
| body mass index | — |
| lean body mass | — |
| pulmonary function | — |
| quality of life | — |
| weight | — |
Countries
United States