Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
NCT ID:
NCT00231192
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.
Study:
NCT00231192
Study Brief:
Protocol Section:
NCT00231192