- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00656864
Pioglitazone Incretin Study
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
-
-
Vermont
-
South Burlington, Vermont, États-Unis, 05403
- University of Vermont
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur placebo: 2
Bras placebo
|
placebo
|
Comparateur actif: 1
Pioglitazone arm
|
Starting dose at 15 mg for two weeks, then titrated up to 45 mg in the subsequent 2 weeks.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Change in incretin-mediated insulin secretion and receptor regulation of glucose-dependent insulinotropic peptide (GIP) in patients with type 2 diabetes.
Délai: 12 weeks per subject
|
12 weeks per subject
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Change in active GIP in response to an oral glucose tolerance test and mixed meal challenge
Délai: 12 weeks
|
12 weeks
|
Change in active GLP-1 in response to the oral glucose tolerance test and the mixed meal challenge
Délai: 12 weeks
|
12 weeks
|
Change in glucose response during the oral glucose tolerance test and mixed meal challenge
Délai: 12 weeks
|
12 weeks
|
Change in insulin secretion during the oral glucose tolerance test and the mixed meal challenge
Délai: 12 weeks
|
12 weeks
|
Change in the acute insulin response to glucose, insulin sensitivity and the disposition index during the IV glucose tolerance test.
Délai: 12 weeks
|
12 weeks
|
Change in adipocyte GIP receptor mRNA expression levels.
Délai: 12 weeks
|
12 weeks
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Richard E Pratley, MD, University of Vermont
Publications et liens utiles
Publications générales
- Nunez Lopez YO, Casu A, Kovacova Z, Petrilli AM, Sideleva O, Tharp WG, Pratley RE. Coordinated regulation of gene expression and microRNA changes in adipose tissue and circulating extracellular vesicles in response to pioglitazone treatment in humans with type 2 diabetes. Front Endocrinol (Lausanne). 2022 Aug 31;13:955593. doi: 10.3389/fendo.2022.955593. eCollection 2022.
- Tharp WG, Gupta D, Sideleva O, Deacon CF, Holst JJ, Elahi D, Pratley RE. Effects of Pioglitazone on Glucose-Dependent Insulinotropic Polypeptide-Mediated Insulin Secretion and Adipocyte Receptor Expression in Patients With Type 2 Diabetes. Diabetes. 2020 Feb;69(2):146-157. doi: 10.2337/db18-1163. Epub 2019 Nov 22.
- Kovacova Z, Tharp WG, Liu D, Wei W, Xie H, Collins S, Pratley RE. Adipose tissue natriuretic peptide receptor expression is related to insulin sensitivity in obesity and diabetes. Obesity (Silver Spring). 2016 Apr;24(4):820-8. doi: 10.1002/oby.21418. Epub 2016 Feb 17.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 08-107
- GCRC-962
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