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Repaglinide for Adolescents With Cystic Fibrosis-Related Diabetes

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ClinicalTrials.gov Identifier: NCT00231192
Recruitment Status : Withdrawn (Unable to recruit any subjects)
First Posted : October 4, 2005
Last Update Posted : March 12, 2015
Sponsor:
Information provided by:
Children's Hospital of Philadelphia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Drug: Repaglinide and Insulin Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Repaglinide for Adolescents With Cystic Fibrosis-Related Diabetes
Study Start Date : October 2005
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
Drug Information available for: Repaglinide

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. blood glucose
  2. insulin excursion during oral glucose tolerance test
  3. fasting blood glucose
  4. 2-hour post-prandial blood glucose
  5. hemoglobin A1C
  6. serum fructosamine

Secondary Outcome Measures :
  1. weight
  2. body mass index
  3. lean body mass
  4. pulmonary function
  5. quality of life

Eligibility Criteria
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Ages Eligible for Study:   12 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Cystic Fibrosis, Blood glucose concerning for diabetes -

Exclusion Criteria:

Known Cystic Fibrosis-Related Diabetes, Liver Disease, FEV1<40%

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00231192


Locations
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United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104-4399
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
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Principal Investigator: Andrea Kelly, MD Children's Hospital of Philadelphia
More Information
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ClinicalTrials.gov Identifier: NCT00231192    
Other Study ID Numbers: 2005-8-4323
Cystic Fibrosis Foundation
First Posted: October 4, 2005    Key Record Dates
Last Update Posted: March 12, 2015
Last Verified: November 2007
Keywords provided by Children's Hospital of Philadelphia:
Diabetes
Adolescents
Cystic Fibrosis
Insulin
Repaglinide
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Repaglinide
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
 Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Hypoglycemic Agents
Physiological Effects of Drugs