Trial record 3 of 366 for:    TODAY Type 2

TODAY Genetics Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00722397
First received: July 23, 2008
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

The TODAY study group has prepared a protocol with the primary objective of collecting blood and phenotypic information to be used to explore relationships between candidate genes and type 2 diabetes (T2D), as well as obesity, insulin resistance, and cardiovascular complications of insulin resistance. Participation in the genetics study includes a blood draw for analysis of diabetes type and DNA extraction, as well as collection of basic family and medical history. Appropriate informed consent and assent are obtained from all participants to extract DNA and send blood, genetic material, and medical history to the Central Repository of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH). The data are kept indefinitely by the Central Repository. The NIDDK will issue requests for proposals (RFP) throughout the scientific community for research that may help in the development of new diagnostic tests, new treatments, and new ways to prevent diabetes and other related comorbidities.


Condition
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Genetics Study

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Blood draw to be processed and analyzed to yield genetic data. [ Time Frame: Blood is drawn at the single study visit. ] [ Designated as safety issue: No ]
    Blood is sent to the DNA processing center identified by NIDDK for processing and shipment to the NIDDK Repository.


Secondary Outcome Measures:
  • Phenotype data. [ Time Frame: Collected at single study visit. ] [ Designated as safety issue: No ]
    Demographic, medical history, and other data about participant and family, by self-report.

  • Laboratory values. [ Time Frame: Single study visit. ] [ Designated as safety issue: No ]
    Serum glucose, C-peptide, and pancreatic autoimmunity antibodies determined by study central laboratory.


Biospecimen Retention:   Samples With DNA

Collect 27 mL of blood to send (1) for extraction of DNA to the NIDDK Central Repository and (2) for measurement of glucose, C-peptide, and autoantibody analysis to a central blood laboratory.


Estimated Enrollment: 2500
Study Start Date: August 2008
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Recruitment is conducted within a 'catchment' area that includes (a) the patient pools of the 15 TODAY clinical centers and (b) collaborating clinics and physicians who either refer subjects to a TODAY site or obtain IRB approval to conduct the protocol at their own locale.

Criteria

Inclusion Criteria:

  • Diabetes by ADA criteria (laboratory determinations of fasting glucose ≥ 126 mg/dL, random glucose ≥ 200 mg/dL, or two-hour oral glucose tolerance test (OGTT) glucose ≥ 200 mg/dL) documented and confirmed in medical record or a laboratory determination of HbA1c ≥ 7%. For asymptomatic patients diagnosed with diabetes with a normal fasting glucose but an elevated two-hour glucose during an OGTT, the HbA1c must be ≥ 6%.
  • BMI ≥ 85th percentile documented at time of diagnosis or at screening.
  • Age < 18 at time of diagnosis.
  • Signed informed consent and assent forms as appropriate.

Exclusion Criteria:

  • Genetic syndrome or disorder known to affect glucose tolerance other than diabetes.
  • Patient on medication known to affect glucose tolerance, insulin sensitivity or secretion within 60 days of the time of diagnosis. If diagnosis is confirmed after the patient has been off the medication for 60 days, the patient may be included. Exclusionary medications include but are not limited to

    1. inhaled steroids at dose above 1000 mcg daily fluticasone equivalent,
    2. oral glucocorticoids,
    3. antirejection or chemotherapy agents (e.g., tacrolimus, L-asparaginase),
    4. atypical antipsychotics.
  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: NCT00722397

Contacts
Contact: Kathryn Hirst, PhD 301-881-9260 ext 8025 khirst@bsc.gwu.edu

  Hide Study Locations
Locations
United States, Arkansas
UAMS Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Cynthia Moreau    501-364-1975    moreaucynthias@uams.edu   
Principal Investigator: Alba Morales, MD         
United States, California
Childrens Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Norma Castaneda    323-361-5627    nzcastaneda@chla.usc.edu   
Principal Investigator: Mitchell Geffner, MD         
UCSD Rady Children's Hospital Recruiting
San Diego, California, United States, 92123
Contact: Michael Stahler    858-966-4032    mstahler@rchsd.org   
Principal Investigator: Michael Gottschalk, MD         
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Amy West    720-777-5774    west.amy@tchden.org   
Principal Investigator: Phil Zeitler, MD PhD         
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Hendrana Gutierrez    860-545-9273    hgutierrez@ccmckids.org   
Principal Investigator: Elizabeth Estrada, MD         
Yale University Recruiting
New Haven, Connecticut, United States, 06519
Contact: Amy N Syme    203-785-2965    amy.johnson@yale.edu   
Principal Investigator: Sonia Caprio, MD         
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Erica Dougherty    352-334-0281    ericadoc@peds.ufl.edu   
Principal Investigator: Janet Silverstein, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Peggy Jenkins    404-712-0051    mjenk03@emory.edu   
Contact: Karen Lindsley    404-727-1098    klindsl@emory.edu   
Principal Investigator: Andrew Muir, MD         
United States, Indiana
Indiana University School of Medicine Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Paula Didrick    317-274-7019    pdidrick@iupui.edu   
Principal Investigator: Zeina Nabhan, MD         
United States, Maryland
George Washington University Biostatistics Center Recruiting
Rockville, Maryland, United States, 20852
Contact: Christen Long    301-881-9260    clong@bsc.gwu.edu   
Principal Investigator: Kathryn Hirst, PhD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Elaine Javier    617-723-2019    ejavier@partners.org   
Principal Investigator: David M Nathan, MD         
Joslin Diabetes Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Maureen Malloy    617-735-1919 ext 4461    maureen.malloy@joslin.harvard.edu   
Principal Investigator: Lori Laffel, MD         
United States, Missouri
Kansas City Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Jennifer Bedard    816-983-6823    jabedard@cmh.edu   
Contact: Terri Leutjen    816-234-3997    tleutjen@cmh.edu   
Principal Investigator: Figen Ugrasbul, MD         
St Louis University Recruiting
St Louis, Missouri, United States, 63104
Contact: Theresa Whelan    314-577-5611    whelantm@slu.edu   
Principal Investigator: Sherida Tollefsen, MD         
Washington University Recruiting
St Louis, Missouri, United States, 63110
Contact: Lexie Timpson    314-286-1108    timpson_a@kids.wustl.edu   
Principal Investigator: Neil White, MD         
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Pat Kringas    212-851-5489    mpk40@columbia.edu   
Principal Investigator: Robin Goland, MD         
State University of New York Upstate Medical University Recruiting
Syracuse, New York, United States, 13214
Contact: Sarah Doolittle    315-464-9008    doolitsj@upstate.edu   
Principal Investigator: Ruth Weinstock, MD PhD         
United States, Ohio
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Amy Schmidt    216-844-1966    amy.schmidt@UHhospitals.org   
Principal Investigator: Leona Cuttler, MD         
United States, Oklahoma
University of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73117
Contact: Jill Schanuel    405-271-8001 ext 43075    jill-schanuel@ouhsc.edu   
Principal Investigator: Ken Copeland, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kevin Gralewski    267-426-7433    gralewskik@email.chop.edu   
Principal Investigator: Lorraine Katz, MD         
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Lori Bednarz    412-692-8723    lori.bednarz@chp.edu   
Principal Investigator: Silva Arslanian, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Amy Potter    615-322-7427    amy.potter@vanderbilt.edu   
Principal Investigator: Amy Potter, MD         
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Andrea Pihlaskari    832-822-1022    akpihlas@texaschildrens.org   
Principal Investigator: Siripoom McKay, MD         
Sub-Investigator: Morey Haymond, MD         
Texas Tech University Health Science Center Recruiting
Lubbock, Texas, United States, 79430
Contact: Chris Scott-Johnson    806-743-4222 ext 225    chris.scott@ttuhsc.edu   
Principal Investigator: Daina Dreimane, MD         
University of Texas Health Science Center Recruiting
San Antonio, Texas, United States, 78207
Contact: Rose Ann Barajas    210-562-5227    barajasr@uthscsa.edu   
Principal Investigator: Jane Lynch, MD         
Sponsors and Collaborators
Investigators
Principal Investigator: Phil Zeitler, MD PhD University of Colorado, Denver
Principal Investigator: Kathryn Hirst, PhD George Washington University
  More Information

No publications provided

Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00722397     History of Changes
Other Study ID Numbers: IND - DK61230-GENETICS, DK61230
Study First Received: July 23, 2008
Last Updated: June 18, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
genetics, pediatrics

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 20, 2014