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Genetic Modifiers of Cystic Fibrosis Related Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01113216
Recruitment Status : Recruiting
First Posted : April 29, 2010
Last Update Posted : December 7, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Cystic Fibrosis Related Diabetes

Detailed Description:
The study is recruiting people with cystic fibrosis (CF). The medical record is being extracted, and a blood sample is taken for DNA. The DNA samples are tested for variation both at the CFTR gene (the CF gene) and over the entire rest of the genome. Using large numbers of people with CF, and knowing who does and does not have CFRD, we identify genetic variations that associate with CFRD. Knowing these variations allows us to better understand the causes of CFRD, and with enough information, better to predict CFRD and identify people at particularly high or low risk of CFRD. People participating in this study also have the option to participate in related studies of other metabolic traits in CF such as over- and underweight.

Study Design

Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Genetic Modifiers of Cystic Fibrosis Related Diabetes
Study Start Date : April 2008
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Identification of Genes or other factors that influence the development of CFRD [ Time Frame: 5 years ]

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 99 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Minnesota - Clinical and Translational Science Institute
Northwestern University
Investigators
Principal Investigator: Scott M Blackman, MD, PhD Johns Hopkins University
More Information

Publications:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01113216     History of Changes
Other Study ID Numbers: CFF-CFRD01
K23DK083551 ( U.S. NIH Grant/Contract )
First Posted: April 29, 2010    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases