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| Sponsor: | National Center for Research Resources (NCRR) |
|---|---|
| Collaborator: |
University of Utah |
| Information provided by: | National Center for Research Resources (NCRR) |
| ClinicalTrials.gov Identifier: | NCT00014768 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Cystic Fibrosis |
Drug: glucose Drug: insulin Drug: leucine |
| Study Type: | Observational |
| Study Design: | Natural History |
| Estimated Enrollment: | 36 |
| Study Start Date: | February 2001 |
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
Other:
Pregnant non-CF controls:
Contacts and Locations More Information
| Study ID Numbers: | 199/15797, UUSOM-IRB-7922-00 |
| Study First Received: | April 10, 2001 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00014768 History of Changes |
| Health Authority: | United States: Federal Government |
|
cardiovascular and respiratory diseases cystic fibrosis genetic diseases and dysmorphic syndromes rare disease |
|
Pathologic Processes Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis |
Fibrosis Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases |
