Adipokines in Obese Adolescents With Insulin Resistance
23 de abril de 2012 atualizado por: Maria Lola Evia-Viscarra, Hospital Regional de Alta Especialidad del Bajio
Inflammatory Mediators in Obese Adolescents With Insulin Resistance Following Metformin Treatment: Controlled Randomized Clinical Trial
The purpose of this study is to compare serum concentrations of inflammatory cytokines, interleukin 6 (IL-6), High-sensitivity C-reactive protein (hs-CRP), adiponectin, and tumour necrosis factor alpha (TNFα), before and after three months treatment with metformin in obese adolescents with insulin resistance (IR).
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
The increased prevalence of obesity in pediatric patients is a public health problem particularly because of the difficulties involved with changing lifestyles. Current studies of obese children and adolescents show increased insulin resistance (IR) and chronic inflammatory states. These conditions increase the risk of disability and/or premature death.
The current treatment schemes for obese children are conservative and are focused on changing their lifestyles (exercise and dietary plans). However, metabolic conditions, such as IR, dyslipidemia, and inflammatory processes, are perpetuated.
Metformin is a biguanide that is used for adolescents with diabetes mellitus and polycystic ovarian syndrome. Several clinical trials with metformin for obese pediatric patients have observed decreases in IR, decreases in weight, and improvements in lipid metabolism.
Adipose tissue is not only an energy repository, but also plays an immunological role by the secretion of cytokines. Both overweight adults and adolescents show decreases in adiponectin levels and increases in tumor necrosis factor alpha (TNFα) and interleukin 6 (IL-6). IL-6 can stimulate the production of high-sensitivity C-reactive protein (hs-CRP), which is considered to be a risk marker for the development of cardiovascular disease.
Tipo de estudo
Intervencional
Inscrição (Real)
31
Estágio
- Fase 4
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Distrito Federal
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México, Distrito Federal, México, 06720
- Hospital Infantil de Mexico Federico Gomez
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Guanajuato
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León, Guanajuato, México, 37670
- Hospital Regional de Alta Especialidad del Bajio
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
9 anos a 18 anos (Filho, Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Obesity defined as Body Mass Index (BMI) ≥ percentile 95
- Tanner stage ≥ 2
- Insulin resistance defined as Basal insulin > 15 µU/mL or Homeostasis Model Assessment index (HOMA) > 4.5
- Patients' parents signed written consents when they and their adolescent children agreed to enroll
Exclusion Criteria:
- Glucose intolerance
- Diabetes mellitus (type 1 or 2)
- Anemia (Hb < 10 g/dL)
- Plasma creatinine > 1.4 mg/dL
- Abnormal hepatic function
- Any associated Disease (Pulmonary, Infection, Autoimmune Disease)
- History of lactic acidosis
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Metformin
Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months.
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Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months.
Outros nomes:
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Comparador de Placebo: Placebo
Tablet of 500 mg oral placebo every 12 hours for 3 months.
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Tablet of 500 mg oral placebo every 12 hours for 3 months.
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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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Adiponectin
Prazo: baseline and 3 months
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Change from baseline in Adiponectin after 3 months of treatment.
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baseline and 3 months
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High-sensitivity C-reactive Protein
Prazo: baseline and 3 months
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Change from baseline in High-sensitivity C-reactive protein after 3 months of treatment.
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baseline and 3 months
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Interleukin 6
Prazo: baseline and 3 months
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Change from baseline in Interleukin 6 after 3 months of treatment.
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baseline and 3 months
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Tumour Necrosis Factor Alpha
Prazo: baseline and 3 months
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Change from baseline in Tumour necrosis factor alpha after 3 months of treatment.
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baseline and 3 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Fasting Plasma Glucose
Prazo: baseline and 3 months
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Change from baseline in Fasting plasma glucose after 3 months of treatment.
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baseline and 3 months
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Fasting Insulin
Prazo: baseline and 3 months
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Change from baseline in Fasting insulin after 3 months of treatment.
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baseline and 3 months
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Body Mass Index
Prazo: baseline and 3 months
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Change from baseline in Body Mass Index after 3 months of treatment.
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baseline and 3 months
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Waist Circumference
Prazo: baseline and 3 months
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Change from baseline in Waist circumference after 3 months of treatment.
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baseline and 3 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Maria L Evia-Viscarra, M.D., Hospital Regional de Alta Especialidad del Bajio
- Cadeira de estudo: Edel R Rodea-Montero, Statistician, Hospital Regional de Alta Especialidad del Bajio
- Cadeira de estudo: Evelia Apolinar-Jiménez, Nutrition, Hospital Regional de Alta Especialidad del Bajio
- Cadeira de estudo: Leticia M García-Morales, M.D., Hospital Infantil de Mexico Federico Gomez
- Cadeira de estudo: Constanza Leaños-Pérez, M.D., Hospital Infantil de Mexico Federico Gomez
- Cadeira de estudo: Mireya Figueroa-Barrón, Chemestry, Hospital Infantil de Mexico Federico Gomez
- Cadeira de estudo: Dolores Sánchez-Fierros, Chemestry, Hospital Infantil de Mexico Federico Gomez
- Cadeira de estudo: Nathalie Muñoz-Noriega, Nutrition, Hospital Regional de Alta Especialidad del Bajio
- Cadeira de estudo: Juan G Reyes-García, M.D., Escuela Superior de Medicina del IPN
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
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- Srinivasan S, Ambler GR, Baur LA, Garnett SP, Tepsa M, Yap F, Ward GM, Cowell CT. Randomized, controlled trial of metformin for obesity and insulin resistance in children and adolescents: improvement in body composition and fasting insulin. J Clin Endocrinol Metab. 2006 Jun;91(6):2074-80. doi: 10.1210/jc.2006-0241. Epub 2006 Apr 4.
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de janeiro de 2007
Conclusão Primária (Real)
1 de dezembro de 2009
Conclusão do estudo (Real)
1 de março de 2010
Datas de inscrição no estudo
Enviado pela primeira vez
4 de agosto de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de agosto de 2011
Primeira postagem (Estimativa)
5 de agosto de 2011
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
27 de abril de 2012
Última atualização enviada que atendeu aos critérios de controle de qualidade
23 de abril de 2012
Última verificação
1 de abril de 2012
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 010-08
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