Repaglinide for Adolescents With Cystic Fibrosis-Related Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Repaglinide for Adolescents With Cystic Fibrosis-Related Diabetes

Conditions
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Diabetes

Intervention / Treatment
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* Drug: Repaglinide and Insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cystic Fibrosis, Blood glucose concerning for diabetes - Exclusion Criteria: Known Cystic Fibrosis-Related Diabetes, Liver Disease, FEV1<40% -

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Repaglinide and Insulin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood glucose |  |  | 
| insulin excursion during oral glucose tolerance test |  |  | 
| fasting blood glucose |  |  | 
| 2-hour post-prandial blood glucose |  |  | 
| hemoglobin A1C |  |  | 
| serum fructosamine |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight |  |  | 
| body mass index |  |  | 
| lean body mass |  |  | 
| pulmonary function |  |  | 
| quality of life |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Adolescents, Cystic Fibrosis, Insulin, Repaglinide