Study of Metabolic Effects of Pregnancy in Women With Cystic Fibrosis
- Conditions
- Cystic Fibrosis
- Registration Number
- NCT00014768
- Lead Sponsor
- National Center for Research Resources (NCRR)
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Utah School of Medicine
🇺🇸Salt Lake City, Utah, United States