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Study of Metabolic Effects of Pregnancy in Women With Cystic Fibrosis

NCT ID: NCT00014768

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-02-28

Brief Summary

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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

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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.

Conditions

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Cystic Fibrosis

Keywords

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cardiovascular and respiratory diseases cystic fibrosis genetic diseases and dysmorphic syndromes rare disease

Study Design

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Observational Model Type

NATURAL_HISTORY

Interventions

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glucose

Intervention Type DRUG

insulin

Intervention Type DRUG

leucine

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

0 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Utah

OTHER

Sponsor Role collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role lead

Principal Investigators

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Dana S. Hardin

Role: STUDY_CHAIR

University of Utah

Locations

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University of Utah School of Medicine

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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UUSOM-IRB-7922-00

Identifier Type: -

Identifier Source: secondary_id

199/15797

Identifier Type: -

Identifier Source: org_study_id