- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02045290
Insulin Clamp Hjelpestudie for vurdering av insulinresistens
Metforminterapi for overvektige ungdommer med type 1-diabetes (T1D)--insulinklemmestøttestudie for vurdering av insulinresistens
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
-
-
Florida
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Tampa, Florida, Forente stater, 33647
- Jaeb Center for Health Research
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inklusjonskriterier:
1. Oppfyller kvalifikasjonskriteriene til hovedstudien, Metforminterapi for overvektige ungdommer med type 1-diabetes (NCT01881828).
Ekskluderingskriterier:
1. Lavt hemoglobin eller hematokrit som definert av hver lokale institusjons regler for insulinklemmer eller hvis ingen institusjonelle krav er hematokrit <30 % eller hemoglobin <10 gm/dL
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Metformin
Metformin 2000 mg per dag
|
Styrken til hver tablett vil være 500 mg.
Deltakerne vil bygge opp til en daglig dose over fire uker ved å ta en tablett per dag i 7 dager, en tablett to ganger daglig i 7 dager, en tablett om morgenen og 2 tabletter om natten i 7 dager, og deretter 2 tabletter om morgenen og 2 tabletter om natten, daglig gjennom resten av studiebehandlingsperioden.
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Placebo komparator: Oral placebo
Et sentralt apotek vil sammensette en placebo for å matche metformintablettene. Placeboproduktet vil inneholde følgende komponenter:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Endring i insulinresistens (IR) fra baseline til 13 uker
Tidsramme: 0-13 uker
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Hyperinsulinemisk euglykemisk klemme for å vurdere metformins innvirkning på muskel-IR via glukoseinfusjonshastighet (GIR).
|
0-13 uker
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Endring i hepatisk IR fra baseline til 13 uker
Tidsramme: 0-13 uker
|
Gradert hyperinsulinemisk euglykemisk klemme med glukose- og glyserolisotoper for å vurdere metformins innvirkning på: • Hepatisk IR |
0-13 uker
|
Endring i Adipose IR fra baseline til 13 uker
Tidsramme: 0-13 uker
|
Gradert hyperinsulinemisk euglykemisk klemme med glukose- og glyserolisotoper for å vurdere metformins innvirkning på: • Fett IR |
0-13 uker
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Ingrid Libman, MD, PhD, Childrens Hospital of University of Pittsburgh Medical Center
- Studiestol: Kristen Nadeau, MD, University of Colorado Denver/Childrens Hospital Colorado
- Hovedetterforsker: Kellee M Miller, MPH, Jaeb Center for Health Research
Publikasjoner og nyttige lenker
Generelle publikasjoner
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- Regensteiner JG. Type 2 diabetes mellitus and cardiovascular exercise performance. Rev Endocr Metab Disord. 2004 Aug;5(3):269-76. doi: 10.1023/B:REMD.0000032416.13070.01. No abstract available.
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- Rewers M, Zaccaro D, D'Agostino R, Haffner S, Saad MF, Selby JV, Bergman R, Savage P; Insulin Resistance Atherosclerosis Study Investigators. Insulin sensitivity, insulinemia, and coronary artery disease: the Insulin Resistance Atherosclerosis Study. Diabetes Care. 2004 Mar;27(3):781-7. doi: 10.2337/diacare.27.3.781.
- Haffner SM, D'Agostino R Jr, Mykkanen L, Tracy R, Howard B, Rewers M, Selby J, Savage PJ, Saad MF. Insulin sensitivity in subjects with type 2 diabetes. Relationship to cardiovascular risk factors: the Insulin Resistance Atherosclerosis Study. Diabetes Care. 1999 Apr;22(4):562-8. doi: 10.2337/diacare.22.4.562.
- Nadeau KJ, Zeitler PS, Bauer TA, Brown MS, Dorosz JL, Draznin B, Reusch JE, Regensteiner JG. Insulin resistance in adolescents with type 2 diabetes is associated with impaired exercise capacity. J Clin Endocrinol Metab. 2009 Oct;94(10):3687-95. doi: 10.1210/jc.2008-2844. Epub 2009 Jul 7.
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- Taskinen MR. Quantitative and qualitative lipoprotein abnormalities in diabetes mellitus. Diabetes. 1992 Oct;41 Suppl 2:12-7. doi: 10.2337/diab.41.2.s12.
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Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- T1DX Insulin Clamp Ancillary
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