Status:
WITHDRAWN
Metabolic Abnormalities in Hispanic Children With Cystic Fibrosis
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
7-17 years
Phase:
NA
Brief Summary
Our specific aims include: 1. AIM 1. Characterization of glucose tolerance, nutritional and clinical status, socioeconomic status, family history of diabetes and genotype in Hispanic CF children comp...
Detailed Description
We will recruit 12 Hispanic prepubertal children with CF (ages 7-12, Tanner I) and 12 Hispanic adolescents (ages 15-17, Tanner 3 or 4) from the CF Centers at University of Texas Southwestern and Baylo...
Eligibility Criteria
Inclusion
- Subjects will be required to be medically stable at the time of the study. Medical stability will be defined as:
- No hospital admission for six weeks or more before the study
- No oral or intravenous antibiotics for at least six weeks preceding the study (subjects will be allowed to use low doses of inhaled corticosteroids)
- Weight-stable (weight deviation less than 2.5 kilograms) for two months prior to the study.
Exclusion
- Use of oral or intravenous corticosteroid medications within six weeks of the study
- Evidence of severe liver disease (hepatomegaly, 30% or greater elevation of liver transaminases, listed for liver transplant)
- Colonization with Burkholderia cepacia
- Pregnancy
- Patients requiring supplemental oxygen.
Key Trial Info
Start Date :
February 2 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00287443
Start Date
February 2 2006
End Date
February 2 2006
Last Update
December 26 2018
Active Locations (1)
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1
Children's Medical Center of Dallas
Dallas, Texas, United States, 75390