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Study of Metabolic Effects of Pregnancy in Women With Cystic Fibrosis



Study of Metabolic Effects of Pregnancy in Women With Cystic Fibrosis

For Condition: Cystic Fibrosis
Status: Terminated
Sponsor(s): National Center for Research Resources (NCRR) , University of Utah
Synopsis: 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.
Details: 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:
Study Type:  Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of cystic fibrosis (CF) and pregnant OR Age, weight, and body mass index matched non-pregnant CF woman or pregnant non-CF woman - No infection with Burkholderia cepacia - FEV1 at least 60% --Prior/Concurrent Therapy-- - At least 3 weeks since prior corticosteroids --Patient Characteristics-- - Hepatic: No more than one transaminase level greater than 10% above normal Other: Pregnant non-CF controls: - No cigarette smokers - No history of gestational diabetes mellitus - No type 1 or 2 diabetes - No other chronic illness
Total Enrollment: 36

Location and Contact Information:

Overall Study Official:
DanaHardin,  Study Chair,  University of Utah

University of Utah School of Medicine
Salt Lake City,  Utah,  84132
United States
 


Additional Information:
Study ID Numbers:  199/15797;  UUSOM-IRB-7922-00
Study Start Date: February 2001
Record last reviewed: March 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014768

Other Cystic Fibrosis Studies:
1. Multicenter Study of Nontuberculous Mycobacteria in Cystic Fibrosis Patients

2. Phase I Pilot Study of Gene Therapy for Cystic Fibrosis Using Cationic Liposome Mediated Gene Transfer

3. Study of Interferon gamma-1b by injection for the treatment of patients with cystic fibrosis

4. Randomized Study of Pancrelipase With Bicarbonate (PANCRECARB) Capsules in Reducing Steatorrhea in Patients With Cystic Fibrosis

5. Safety and Efficacy Study of Nutropin AQ to Treat Growth Restriction in Children with Cystic Fibrosis

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