Genetic Modifiers of Cystic Fibrosis Related Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Johns Hopkins University
Sponsor:
Collaborators:
Cystic Fibrosis Foundation Therapeutics
University of Minnesota - Clinical and Translational Science Institute
Northwestern University
Information provided by (Responsible Party):
Scott Blackman, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01113216
First received: April 28, 2010
Last updated: April 21, 2015
Last verified: April 2015
  Purpose

This research is being done to find the genes and other factors that are responsible for differences among persons with cystic fibrosis. We are particularly interested in the factors that relate to the development of Cystic Fibrosis Related Diabetes (CFRD).


Condition
Cystic Fibrosis Related Diabetes

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Genetic Modifiers of Cystic Fibrosis Related Diabetes

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Identification of Genes or other factors that influence the development of CFRD [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood will be drawn from study participants and their parents. Two tablespoons of blood (one tablespoon in small children) will be drawn by standard techniques from a vein in the arm. Whenever possible, blood samples for this study will be collected at the same time that it is done for medically needed blood tests. This blood will be used to extract DNA and to establish cell lines that we will store as a permanent source of DNA. We will compare your clinical symptoms with your DNA to see if additional genes that affect CF symptoms can be found. Some serum and plasma will be stored for later testing, as additional knowledge becomes available. Any tests done in the future with your stored blood samples or your DNA will only be to answer questions about genes for CF.


Estimated Enrollment: 1500
Study Start Date: April 2008
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   3 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Individuals affected with Cystic Fibrosis and family members

Criteria

Inclusion Criteria:

  • Any person with Cystic Fibrosis and his/her parents.

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01113216

Locations
United States, Illinois
Children's Memorial Hospital Not yet recruiting
Chicago, Illinois, United States
Contact: Susanna McColley, MD       smccolley@northwestern.edu   
United States, Maryland
Johns Hopkins Medicine Recruiting
Baltimore, Maryland, United States, 21287
Contact: Scott M Blackman, MD, PhD    410-955-6463    sblackman@jhmi.edu   
Contact: Karen S Raraigh, MS    410-502-7124    kraraigh@jhmi.edu   
United States, Minnesota
University of Minnesota Not yet recruiting
Minneapolis, Minnesota, United States
Contact: Antoinette Moran, MD       moran001@tc.uminn.edu   
Sponsors and Collaborators
Johns Hopkins University
Cystic Fibrosis Foundation Therapeutics
University of Minnesota - Clinical and Translational Science Institute
Northwestern University
Investigators
Principal Investigator: Scott M Blackman, MD, PhD Johns Hopkins Medicine
  More Information

Publications:
Responsible Party: Scott Blackman, Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01113216     History of Changes
Other Study ID Numbers: CFF-CFRD01, K23DK083551
Study First Received: April 28, 2010
Last Updated: April 21, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
CF
CFRD
Diabetes
Genetic Modifiers

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 27, 2015