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Tracking Information | |||||
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First Received Date † | April 10, 2001 | ||||
Last Updated Date | June 23, 2005 | ||||
Start Date † | February 2001 | ||||
Current Primary Outcome Measures † | |||||
Original Primary Outcome Measures † | |||||
Change History | Complete list of historical versions of study NCT00014768 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Study of Metabolic Effects of Pregnancy in Women With Cystic Fibrosis | ||||
Official Title † | |||||
Brief Summary | OBJECTIVES: I. Compare the clinical status of pregnant vs non-pregnant women with cystic fibrosis. II. Determine glucose tolerance during each trimester of pregnancy in these women. III. Evaluate peripheral insulin sensitivity in these women. IV. Evaluate whole body protein turnover and hepatic glucose production in these women. V. Determine resting energy expenditure in these women. |
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Detailed Description | PROTOCOL OUTLINE: Patients undergo a glucose tolerance test over 3 hours and a potassium body scan on day 1. Patients undergo an indirect calorimetry over 20 minutes on day 2. Patients receive stable-labeled leucine and stable-labeled glucose IV over 3 hours followed by insulin and glucose IV over 4-4.5 hours on day 2 using the hyperinsulinemic euglycemic clamp technique. Blood and breath samples are collected to measure glucose tolerance, peripheral insulin sensitivity, and whole body protein turnover. Hepatic glucose production is measured by mass spectrophotometry. Patients maintain a 3-day food journal before pregnancy, during each trimester, and after pregnancy. Patients undergo each study during the final 2 weeks of each trimester of pregnancy and then at 6 months post-partum. |
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Study Phase | |||||
Study Type † | Observational | ||||
Study Design † | Natural History | ||||
Condition † | Cystic Fibrosis | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Terminated | ||||
Enrollment † | 36 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | PROTOCOL ENTRY CRITERIA: --Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
Other: Pregnant non-CF controls:
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Gender | Female | ||||
Ages | |||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00014768 | ||||
Responsible Party | |||||
Secondary IDs †† | UUSOM-IRB-7922-00 | ||||
Study Sponsor † | National Center for Research Resources (NCRR) | ||||
Collaborators †† | University of Utah | ||||
Investigators † |
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Information Provided By | National Center for Research Resources (NCRR) | ||||
Verification Date | March 2002 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |