Metabolic Abnormalities in Hispanic Children With Cystic Fibrosis
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ClinicalTrials.gov Identifier: NCT00287443 |
Recruitment Status :
Withdrawn
(PI no longer with the University)
First Posted : February 6, 2006
Last Update Posted : December 26, 2018
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Sponsor:
University of Texas Southwestern Medical Center
Collaborator:
Genentech, Inc.
Information provided by:
University of Texas Southwestern Medical Center
Tracking Information | ||||
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First Submitted Date ICMJE | February 2, 2006 | |||
First Posted Date ICMJE | February 6, 2006 | |||
Last Update Posted Date | December 26, 2018 | |||
Estimated Study Start Date ICMJE | February 2, 2006 | |||
Estimated Primary Completion Date | February 2, 2006 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE | Not Provided | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Metabolic Abnormalities in Hispanic Children With Cystic Fibrosis | |||
Official Title ICMJE | Not Provided | |||
Brief Summary | Our specific aims include:
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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 Baylor College of Medicine in Houston. Information obtained from these subjects will be compared to 12 prepubertal and 12 adolescent Caucasian children with CF recruited from the same CF centers. We will categorize the subjects according to glucose tolerance (OGTT), as well as insulin secretion and insulin sensitivity using the IVGTT and the Minimal Model, as modified for children. We will also compare the historical information of socio-economic status and family history. Clinical status will be characterized by measuring pulmonary function and modified NIH scores, in addition to measuring levels of circulating cytokines. Gluconeogenesis (GNG) will be quantified by measuring the incorporation 2H into the 2nd, 5th and 6th carbons of glucose. Whole body protein turnover (WBPT) will be measured using [1-13C]leucine. Nutritional status will be determined by three-day food journals, and intake will be compared to energy needs, utilizing indirect calorimetry to measure resting energy expenditure. Subjects will be recruited from the CF centers at the University of Texas- Southwestern and the South Central CF Consortium. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Other |
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Condition ICMJE | Cystic Fibrosis | |||
Intervention ICMJE |
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Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Withdrawn | |||
Actual Enrollment ICMJE |
0 | |||
Original Enrollment ICMJE |
48 | |||
Actual Study Completion Date ICMJE | February 2, 2006 | |||
Estimated Primary Completion Date | February 2, 2006 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: Subjects will be required to be medically stable at the time of the study. Medical stability will be defined as:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 7 Years to 17 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00287443 | |||
Other Study ID Numbers ICMJE | 0303-161 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Not Provided | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | University of Texas Southwestern Medical Center | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Genentech, Inc. | |||
Investigators ICMJE |
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PRS Account | University of Texas Southwestern Medical Center | |||
Verification Date | December 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |