Cystic FibrosisNCT00014768
Study of Metabolic Effects of Pregnancy in Women With Cystic Fibrosis
An observational study of Cystic Fibrosis, run by National Center for Research Resources (NCRR) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 0 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- glucose, insulin and leucine
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2001to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah School of Medicine
Salt Lake City, Utah, 84132
About this study
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.
- Determine resting energy expenditure in these women.
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- glucose, insulin, leucine
- Keywords
- cardiovascular and respiratory diseases, cystic fibrosis, genetic diseases and dysmorphic syndromes, rare disease
- Medical subject headings
- Cystic Fibrosis, Respiratory Tract Diseases, Genetic Diseases, Inborn, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucoseDrug
insulinDrug
leucineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2001 (estimated)
- Study startFeb 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Natural history
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Utah
- Investigators
- Dana S. Hardin, Study chair, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00014768
- Sponsor's protocol ID
- 199/15797
- Other IDs
- UUSOM-IRB-7922-00
- Status last verified
- Mar 2002
- First submitted
- 10 Apr 2001
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Metabolic Effects of Pregnancy in Women With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00014768
- Acronym / sponsor ID
- 199/15797
- Conditions
- Cystic Fibrosis
- Keywords
- cardiovascular and respiratory diseases, cystic fibrosis, genetic diseases and dysmorphic syndromes, rare disease
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 36 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- University of Utah
- Study start
- Feb 2001
- First posted
- 11 Apr 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Observational model
- Natural history
Who may qualify
- Ages
- 0 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glucose | Drug | – |
| insulin | Drug | – |
| leucine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dana S. Hardin study chair
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by National Center for Research Resources (NCRR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.