NCT00014768

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 11, 2001

Completed
Last Updated

June 24, 2005

Status Verified

March 1, 2002

First QC Date

April 10, 2001

Last Update Submit

June 23, 2005

Conditions

Cystic Fibrosis

Keywords

cardiovascular and respiratory diseasescystic fibrosisgenetic diseases and dysmorphic syndromesrare disease

Interventions

glucoseDRUG
insulinDRUG
leucineDRUG

Eligibility Criteria

Age0 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Utah School of Medicine

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Cystic FibrosisRespiratory Tract DiseasesGenetic Diseases, InbornRare Diseases

Interventions

GlucoseInsulinLeucine

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsAmino Acids, Branched-ChainAmino AcidsAmino Acids, Essential

Study Officials

  • Dana S. Hardin

    University of Utah

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
NATURAL HISTORY
Sponsor Type
NIH

Study Record Dates

First Submitted

April 10, 2001

First Posted

April 11, 2001

Study Start

February 1, 2001

Last Updated

June 24, 2005

Record last verified: 2002-03

Locations

US(1)