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TODAY Genetics Study

28. juli 2021 opdateret af: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Genetics Study

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.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

2654

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72202
        • UAMS Arkansas Children's Hospital
    • California
      • Los Angeles, California, Forenede Stater, 90027
        • Childrens Hospital Los Angeles
      • San Diego, California, Forenede Stater, 92123
        • UCSD Rady Children's Hospital
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • University of Colorado Denver
    • Connecticut
      • Hartford, Connecticut, Forenede Stater, 06106
        • Connecticut Children's Medical Center
      • New Haven, Connecticut, Forenede Stater, 06519
        • Yale University
    • Florida
      • Gainesville, Florida, Forenede Stater, 32611
        • University of Florida
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Emory University
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Indiana University School of Medicine
    • Maryland
      • Rockville, Maryland, Forenede Stater, 20852
        • George Washington University Biostatistics Center
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, Forenede Stater, 02215
        • Joslin Diabetes Center
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64108
        • Kansas City Children's Mercy Hospital
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Washington University
      • Saint Louis, Missouri, Forenede Stater, 63104
        • St Louis University
    • New York
      • New York, New York, Forenede Stater, 10032
        • Columbia University
      • Syracuse, New York, Forenede Stater, 13214
        • State University of New York Upstate Medical University
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106
        • Case Western Reserve University
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73117
        • University of Oklahoma
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • Children's Hospital of Pittsburgh
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Baylor College of Medicine
      • Lubbock, Texas, Forenede Stater, 79430
        • Texas Tech University Health Science Center
      • San Antonio, Texas, Forenede Stater, 78207
        • University of Texas Health Science Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Blood draw to be processed and analyzed to yield genetic data.
Tidsramme: Blood is drawn at the single study visit.
Blood is sent to the DNA processing center identified by NIDDK for processing and shipment to the NIDDK Repository.
Blood is drawn at the single study visit.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Phenotype data.
Tidsramme: Collected at single study visit.
Demographic, medical history, and other data about participant and family, by self-report.
Collected at single study visit.
Laboratory values.
Tidsramme: Single study visit.
Serum glucose, C-peptide, and pancreatic autoimmunity antibodies determined by study central laboratory.
Single study visit.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Efterforskere

  • Ledende efterforsker: Kathryn Hirst, PhD, George Washington University
  • Ledende efterforsker: Phil Zeitler, MD PhD, University of Colorado, Denver

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2008

Primær færdiggørelse (Faktiske)

1. februar 2015

Studieafslutning (Faktiske)

1. februar 2015

Datoer for studieregistrering

Først indsendt

23. juli 2008

Først indsendt, der opfyldte QC-kriterier

23. juli 2008

Først opslået (Skøn)

25. juli 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. august 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. juli 2021

Sidst verificeret

1. juli 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IND - DK61230-GENETICS
  • DK61230

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
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