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Brief Title: Adipokines in Obese Adolescents With Insulin Resistance
Official Title: Inflammatory Mediators in Obese Adolescents With Insulin Resistance Following Metformin Treatment: Controlled Randomized Clinical Trial
Study ID: NCT01410604
Brief Summary: 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).
Detailed Description: 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.
Minimum Age: 9 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Hospital Infantil de México Federico Gómez, México, Distrito Federal, Mexico
Hospital Regional de Alta Especialidad del Bajío, León, Guanajuato, Mexico
Name: Maria L Evia-Viscarra, M.D.
Affiliation: Hospital Regional de Alta Especialidad del Bajio
Role: PRINCIPAL_INVESTIGATOR
Name: Edel R Rodea-Montero, Statistician
Affiliation: Hospital Regional de Alta Especialidad del Bajio
Role: STUDY_CHAIR
Name: Evelia Apolinar-Jiménez, Nutrition
Affiliation: Hospital Regional de Alta Especialidad del Bajio
Role: STUDY_CHAIR
Name: Leticia M García-Morales, M.D.
Affiliation: Hospital Infantil de Mexico Federico Gomez
Role: STUDY_CHAIR
Name: Constanza Leaños-Pérez, M.D.
Affiliation: Hospital Infantil de Mexico Federico Gomez
Role: STUDY_CHAIR
Name: Mireya Figueroa-Barrón, Chemestry
Affiliation: Hospital Infantil de Mexico Federico Gomez
Role: STUDY_CHAIR
Name: Dolores Sánchez-Fierros, Chemestry
Affiliation: Hospital Infantil de Mexico Federico Gomez
Role: STUDY_CHAIR
Name: Nathalie Muñoz-Noriega, Nutrition
Affiliation: Hospital Regional de Alta Especialidad del Bajio
Role: STUDY_CHAIR
Name: Juan G Reyes-García, M.D.
Affiliation: Escuela Superior de Medicina del IPN
Role: STUDY_CHAIR