NCT02225899

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 26, 2014

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2018

Completed
Last Updated

November 29, 2019

Status Verified

November 1, 2019

Enrollment Period

4.2 years

First QC Date

August 21, 2014

Last Update Submit

November 27, 2019

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

  • Acylcarnitine analysis by high-resolution liquid chromatography mass spectrometry

    This will pe performed using targeted metabolomics methods

    Baseline for cross-sectional study and 1 year for longitudinal study

Secondary Outcomes (1)

  • quantitative plasma levels of specific plasma acylcarnitines

    Baseline for cross-sectional study and 1 year for longitudinal study

Other Outcomes (2)

  • whole-body fasting fat oxidation

    Baseline for cross-sectional study and 1 year for longitudinal study

  • 31P-magnetic resonance spectroscopy (MRS)-derived measures of resting thigh skeletal muscle bioenergetic metabolism

    Baseline for cross-sectional study

Study Arms (3)

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.

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adults with cystic fibrosis and healthy volunteers from the Atlanta community

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Healthy volunteers
  • yrs of age
  • ambulatory status
  • absence of hospitalization in the previous year except for accidents
  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

We will collect sputum, urine, and blood.

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Jessica A Alvarez, PhD, RD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 21, 2014

First Posted

August 26, 2014

Study Start

September 1, 2014

Primary Completion

November 7, 2018

Study Completion

November 7, 2018

Last Updated

November 29, 2019

Record last verified: 2019-11

Locations

US(1)