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Pioglitazone Incretin Study

1. februar 2011 opdateret af: University of Vermont

Effects of Pioglitazone on the Regulation of Insulin Secretion in Patients With Type 2 Diabetes

Incretin hormones are hormones produced by the gut in response to food intake. These hormones help the body to control the metabolism of glucose (sugar). In particular, two incretin hormones (GLP-1 and GIP) cause the pancreas to secrete more insulin in response to high blood glucose levels. This helps the body to metabolize the glucose more effectively, lowering blood sugar levels. GLP-1 and GIP do not work as well in patients with type 2 diabetes (T2DM) as in subjects who do not have diabetes. This study tests whether a medicine called pioglitazone (Actos), which is commonly used to treat T2DM, improves the ability of GIP to increase insulin secretion.

To address this question the investigators will recruit patients with T2DM whose diabetes is controlled with either diet and exercise or with metformin (another medicine commonly used to treat T2DM). Subjects will undergo measurement of body fat by DEXA scanning and a series of studies to characterize their metabolism. These studies include an oral glucose tolerance test (a test sometimes used to diagnose diabetes), a mixed-meal challenge (to measure how much GLP-1 and GIP are produced in response to a meal) and measurement of insulin secretion in response to glucose and GIP given through a vein. The investigators will also obtain small samples of fat (from just under the skin of the belly) using a needle to measure levels of the receptor for GIP. Subjects will then be randomly assigned to 12 weeks of treatment with either pioglitazone or matching placebo (an inactive tablet that does not contain medication). The dose of pioglitazone will be increased during the first 4 weeks to the maximum prescribed dose of 45 mg per day. Subjects will be seen every 2-4 weeks during the treatment phase of the study. After 12 weeks of treatment all studies performed at the beginning of the study will be repeated. The pioglitazone treatment will continue until the end of testing, approximately 4 weeks.

The results of this study may give us information about why glucose control deteriorates in T2DM. This information might also lead to new ways to prevent or treat T2DM.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

24

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Vermont
      • South Burlington, Vermont, Forenede Stater, 05403
        • University of Vermont

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

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Type 2 diabetes controlled with diet+exercise or metformin monotherapy
  • HbA1c less than or equal to 7%
  • Women will be non-fertile or practicing birth control

Exclusion Criteria:

  • Acute or chronic medical conditions that would contraindicate participation
  • Class III or IV heart failure
  • Pregnant or nursing women
  • Patients taking antidiabetic medications other than metformin, oral or chronic topical steroids, weight loss agents, antipsychotics, or other drugs that could affect insulin sensitivity or secretion.
  • AST or ALT more than 2.5 times the upper limit of normal
  • Active alcohol or drug abuse
  • Weight greater than 300 pounds

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: 2
Placebo arm
Medicin: Placebo
placebo
Aktiv komparator: 1
Pioglitazone arm
Medicin: Pioglitazone
Starting dose at 15 mg for two weeks, then titrated up to 45 mg in the subsequent 2 weeks.
Andre navne:
  • Actos (brand name for pioglitazone)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change in incretin-mediated insulin secretion and receptor regulation of glucose-dependent insulinotropic peptide (GIP) in patients with type 2 diabetes.
Tidsramme: 12 weeks per subject
12 weeks per subject

Sekundære resultatmål

Resultatmål
Tidsramme
Change in active GIP in response to an oral glucose tolerance test and mixed meal challenge
Tidsramme: 12 weeks
12 weeks
Change in active GLP-1 in response to the oral glucose tolerance test and the mixed meal challenge
Tidsramme: 12 weeks
12 weeks
Change in glucose response during the oral glucose tolerance test and mixed meal challenge
Tidsramme: 12 weeks
12 weeks
Change in insulin secretion during the oral glucose tolerance test and the mixed meal challenge
Tidsramme: 12 weeks
12 weeks
Change in the acute insulin response to glucose, insulin sensitivity and the disposition index during the IV glucose tolerance test.
Tidsramme: 12 weeks
12 weeks
Change in adipocyte GIP receptor mRNA expression levels.
Tidsramme: 12 weeks
12 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

University of Vermont

Samarbejdspartnere

Takeda

Efterforskere

  • Ledende efterforsker: Richard E Pratley, MD, University of Vermont

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. maj 2008

Primær færdiggørelse (Faktiske)

1. november 2010

Studieafslutning (Faktiske)

1. november 2010

Datoer for studieregistrering

Først indsendt

7. april 2008

Først indsendt, der opfyldte QC-kriterier

10. april 2008

Først opslået (Skøn)

11. april 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. februar 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. februar 2011

Sidst verificeret

1. januar 2010

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 08-107
  • GCRC-962

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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Placeringer

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