Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to provide the necessary data and experience to design a larger, full scale clinical trial to determine if a certain medicine (repaglinide), which increases the amount of insulin secreted by the pancreas, can improve the nutritional status and pulmonary function of adolescents and young adults with cystic fibrosis and prediabetes by improving blood glucose control. The investigators are also trying to determine the relationship between systemic inflammatory factors and glucose impairment.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arbelaez, Ana Maria
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH); Novo Nordisk A/S; Washington University School of Medicine
• Treatments: Repaglinide

Criteria

Inclusion Criteria:

• Male or females 12 -24 years old

• Diagnosis of Cystic Fibrosis by sweat test with exocrine pancreatic insufficiency

• Must have a glucose pattern by Oral Glucose Tolerance Test with fasting blood glucose <126 mg/dl and 2 hour: 140 - 199 mg/dl or >200 mg/dl.

• Weight must be stable within 5% for 3 months prior to initiation visit

• Must be able to reproducibly perform spirometry based on American Thoracic Society guidelines

Exclusion Criteria:

• Patients receiving growth hormone therapy or taking insulin

• Patients with evidence of liver dysfunction

• Patients who are status-post lung or liver transplantation

• Patients who have received systemic steroids for more than 28 days during the 6 months prior to the study

• Patients with active ABPA on steroids

• Patients taking medications that affect glucose metabolism or contraindicated with repaglinide