Effects of Rosiglitazone on the Metabolic Phenotype of Impaired Glucose Tolerance in Youth
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Impaired Glucose Tolerance (IGT) is a prelude to diabetes, which is increasing in prevalence in obese children and adolescents with marked obesity. This condition tends to progress to Type 2 Diabetes Mellitus (T2DM) at an alarmingly rapid tempo. The increased prevalence of childhood and adolescent obesity and greater risk of IGT, and progression to diabetes, in this population set the stage for a series of studies aimed at understanding the metabolic phenotype and natural history of pre-diabetes in obese youth. The investigators found that obese children and adolescents with IGT are characterized by marked insulin resistance related to altered lipid partitioning, favoring lipid deposition in the visceral and intramyocellular compartment. Furthermore, the investigators found an impairment of the acute insulin response in these youngsters. Follow-up revealed a rapid deterioration from IGT to frank diabetes. Based on these studies, there is a strong rationale for changing the balance between visceral and subcutaneous fat and muscle lipid content in a more favorable pattern in order to improve insulin sensitivity.
The primary objective of this study is to determine, in a group of ethnically diverse children and adolescents with IGT, whether treatment with rosiglitazone leads to improvements in insulin sensitivity and glucose tolerance. Secondary objectives are to determine whether rosiglitazone is safe and well tolerated.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Connecticut
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New Haven, Connecticut, États-Unis, 06520
- Yale School of Medicine
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Good general health
- Aged 10 to 18 yrs (females: Tanner stage II-V;and males:testes size>6ml)
- IGT based on 2-hr plasma glucose>140mg/dl and <200mg/dl during an OGTT.
Exclusion Criteria:
- Baseline creatinine>1.0mg
- AST and ALT>2.5 ULN
- Anemia (Hct<30)
- Pregnancy (females must have a negative urine pregnancy test during the study)
- Cardiac or pulmonary or other significant chronic illness
- Plans to increase the frequency or intensity of a regular exercise program
- Psychiatric disorder or substance abuse of anorexic agents.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: 1
Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan.
Subject then receives Rosiglitazone.
Subjects are followed every 2 weeks.
Imaging repeated at 2 months.
12 week follow up.
And then all tests are repeated at 4 months.
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2mg to begin then 4mg, twice daily for 4 months
Autres noms:
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Comparateur placebo: 2
Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR.
Subject is randomized (double-blind) to placebo.
Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.
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Subject receives placebo.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Mean Percent Change From Baseline in Whole-body Insulin Sensitivity
Délai: 4 months
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This describes the percent changes in insulin sensitivity.
Insulin sensitivity was expressed as whole body insulin sensitivity index (WBISI) which is based on the values of insulin (microunits per milliliter) and glucose (milligrams per deciliter) obtained from the OGTT and the corresponding fasting values.The formula is: WBISI=10.000/square
root of (fasting glucose x fasting insulin)x(mean glucose x mean insulin).
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4 months
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Mean Percent Change in Visceral-to-subcutaneous Abdominal Fat
Délai: 4 months
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This describes the percent changes of the ratio between visceral and subcutaneous abdominal fat.
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4 months
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Percentage of Subjects Who Converted Impaired Glucose Tolerance (IGT) to Normal Glucose Tolerance (NGT)
Délai: 4 months
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This refers to the number of subjects that converted from IGT to NGT.
NGT is defined as fasting glucose lower than 100 mg/dl and 2 hours glucose lower than 140 mg/dl.
IGT is defined as 2 hours glucose higher than 140 mg/dl.
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4 months
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Mean Percent Change From Baseline in Hepatic Fat Fraction (HFF)
Délai: 4 months
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It refers to the percent changes of hepatic fat content.
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4 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Mean Percent Change From Baseline in Adiponectin
Délai: 4 months
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This refers to the changes of adiponectin levels.
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4 months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Sonia Caprio, MD, Yale School of Medicine Department of Pediatric Endocrinology
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
- 0508000532
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