Study of Metabolic Effects of Pregnancy in Women With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00014768
• Other study ID #: 199/15797
• Secondary ID: UUSOM-IRB-7922-0
• Status: Terminated
• Phase: N/A
• First received: April 10, 2001
• Last updated: June 23, 2005
• Start date: February 2001

Study information

• Verified date: March 2002
• Source: National Center for Research Resources (NCRR)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 36
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Natural History

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• glucose

• insulin

• leucine

Locations

Country	Name	City	State
United States	University of Utah School of Medicine	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)	University of Utah

Country where clinical trial is conducted

United States,