Effects of Rosiglitazone on the Metabolic Phenotype of Impaired Glucose Tolerance in Youth
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06520
- Yale School of Medicine
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: 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
Outros nomes:
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Comparador de 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Mean Percent Change From Baseline in Whole-body Insulin Sensitivity
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Mean Percent Change From Baseline in Adiponectin
Prazo: 4 months
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This refers to the changes of adiponectin levels.
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4 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sonia Caprio, MD, Yale School of Medicine Department of Pediatric Endocrinology
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 0508000532
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