Cystic FibrosisBEAM-CFNCT02225899
BioEnergetics and Metabolomics in Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Emory University at 1 site in United States.
Trial summary
With better medical care, patients with cystic fibrosis (CF), a life-threatening disease, are enjoying longer lives. As the CF life expectancy increases, conditions such as CF-related diabetes (CFRD) become more prevalent. Nutrition plays a major role in maintaining optimal health in cystic fibrosis (CF). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 7 Nov 2018
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adults with cystic fibrosis and healthy volunteers from the Atlanta community
Who may be able to join
- have confirmed CF diagnosis with at least one Class I to III CFTR mutations
- age ≥ 18 yrs
- on a clinically-stable medical regimen for 3 wks
- no intravenous or oral antibiotics for at least 3 wks prior to study visit
- 18-50 yrs of age
- ambulatory status
- absence of hospitalization in the previous year except for accidents
Who cannot join
- current pregnancy
- unwilling or unable to discontinue enteral tube feeds for one night before the study visit, if applicable
- most recent FEV1% <40%
- drug (recreational or prescription) or alcohol abuse
- pacemaker or any electronic implantable device
- unable to give informed consent
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- Healthy volunteers
- current pregnancy
- current active malignant neoplasm or history of malignancy (other than localized basal cell cancer of the skin) during the previous 5 years
- current respiratory disease including asthma, chronic obstructive pulmonary disorder, or emphysema
- current chronic autoimmune or pro-inflammatory disease
- history of tuberculosis, HIV, or other chronic infection
- previous diagnosis of type 1 or type 2 diabetes with active treatment with insulin or other glucose lowering medication
- advanced (≥ stage 3) renal disease
- body mass index (BMI) ≥ 30 kg/m2
- acute illness (such as a viral infection) within the past 2 weeks
- current use of any prescription medications that would indicate presence of an acute or chronic medical condition that may influence study results
- drug (recreational or prescription) or alcohol abuse
- weight instability (± 10% body weight within the last 6 months) or current participation in weight loss or weight gain program
- inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integration of Nutritional Metabolomics With Bioenergetics in Cystic Fibrosis
With better medical care, patients with cystic fibrosis (CF), a life-threatening disease, are enjoying longer lives. As the CF life expectancy increases, conditions such as CF-related diabetes (CFRD) become more prevalent. Nutrition plays a major role in maintaining optimal health in cystic fibrosis (CF). This project is designed to investigate nutrition-related factors, such as diet and body composition, on outcomes in patients with CF. The data generated from this study will be used to inform future nutrition intervention studies in adults with CF and CFRD.
Read the detailed description
Research methods include blood draws for plasma markers of oxidative stress and metabolomics (the measurement of thousands of small chemicals in the blood), magnetic resonance imaging (MRI, to assess energy capacity and thigh fat), dual energy X-ray absorptiometry (DEXA, to assess total and regional body fat and muscle), and indirect calorimetry (to assess resting energy expenditure and whole body fat oxidation). Clinically-relevant data, such as lung function, CF genotype, and diabetes status will be obtained from the electronic medical record and the CF Registry.
- Conditions
- Cystic Fibrosis
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Cystic Fibrosis | Cross-sectional, observational study | |
| healthy volunteers | Cross-sectional, observational study | |
| Subjects with CF in a vitamin D study | This is a longitudinal observational study in subjects enrolled in a high-dose vitamin D study. The investigator (Jessica Alvarez) does not assign the intervention to the subjects of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acylcarnitine analysis by high-resolution liquid chromatography mass spectrometry
This will pe performed using targeted metabolomics methods
Measured: Baseline for cross-sectional study and 1 year for longitudinal study
Secondary outcomes (1)
quantitative plasma levels of specific plasma acylcarnitines
This will be measured in fasted blood
Measured: Baseline for cross-sectional study and 1 year for longitudinal study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study startSep 2014
- Primary completion7 Nov 2018
- Study completion7 Nov 2018
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.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Alvarez, Emory University
- Investigators
- Jessica A Alvarez, PhD, RD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225899
- Sponsor's protocol ID
- IRB00073559
- Other IDs
- K01DK102851
- Acronym
- BEAM-CF
- Status last verified
- Nov 2019
- First submitted
- 21 Aug 2014
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Nutritional Metabolomics With Bioenergetics in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02225899
- Acronym / sponsor ID
- BEAM-CF / IRB00073559
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2014
- Primary completion
- 7 Nov 2018 (actual)
- Study completion
- 7 Nov 2018 (actual)
- First posted
- 26 Aug 2014 (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.
With better medical care, patients with cystic fibrosis (CF), a life-threatening disease, are enjoying longer lives. As the CF life expectancy increases, conditions such as CF-related diabetes (CFRD) become more prevalent. Nutrition plays a major role in maintaining optimal health in cystic fibrosis (CF). This project is designed to investigate nutrition-related factors, such as diet and body composition, on outcomes in patients with CF. The data generated from this study will be used to inform future nutrition intervention studies in adults with CF and CFRD.
Detailed description
Research methods include blood draws for plasma markers of oxidative stress and metabolomics (the measurement of thousands of small chemicals in the blood), magnetic resonance imaging (MRI, to assess energy capacity and thigh fat), dual energy X-ray absorptiometry (DEXA, to assess total and regional body fat and muscle), and indirect calorimetry (to assess resting energy expenditure and whole body fat oxidation). Clinically-relevant data, such as lung function, CF genotype, and diabetes status will be obtained from the electronic medical record and the CF Registry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subjects with Cystic Fibrosis | – | –Cross-sectional, observational study |
| healthy volunteers | – | –Cross-sectional, observational study |
| Subjects with CF in a vitamin D study | – | –This is a longitudinal observational study in subjects enrolled in a high-dose vitamin D study. The investigator (Jessica Alvarez) does not assign the intervention to the subjects of the study. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adults with cystic fibrosis and healthy volunteers from the Atlanta community
Key inclusion criteria (7 listed)
- have confirmed CF diagnosis with at least one Class I to III CFTR mutations
- age ≥ 18 yrs
- on a clinically-stable medical regimen for 3 wks
- no intravenous or oral antibiotics for at least 3 wks prior to study visit
- 18-50 yrs of age
Key exclusion criteria (20 listed)
- current pregnancy
- unwilling or unable to discontinue enteral tube feeds for one night before the study visit, if applicable
- most recent FEV1% <40%
- drug (recreational or prescription) or alcohol abuse
- pacemaker or any electronic implantable device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acylcarnitine analysis by high-resolution liquid chromatography mass spectrometry
Time frame: Baseline for cross-sectional study and 1 year for longitudinal study
This will pe performed using targeted metabolomics methods
1 secondary outcome
quantitative plasma levels of specific plasma acylcarnitines
Time frame: Baseline for cross-sectional study and 1 year for longitudinal study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
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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.
Jessica A Alvarez, PhD, RD principal investigator
Emory University
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 Emory University 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?
The sponsor lists 7 inclusion and 20 exclusion criteria. 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: finished, as of the sponsor's last update on 29 Nov 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Acylcarnitine analysis by high-resolution liquid chromatography mass spectrometry (time frame: Baseline for cross-sectional study and 1 year for longitudinal study). It is what the study was designed to measure, not a finding.
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 29 Nov 2019.