Inflammatory Mediators in Obese Adolescents With Insulin Resistance Following Metformin Treatment: Controlled Randomized Clinical Trial
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Adiponectin
Change from baseline in Adiponectin after 3 months of treatment.
baseline and 3 months
Yes
Maria L Evia-Viscarra, M.D.
Principal Investigator
Hospital Regional de Alta Especialidad del Bajío
Mexico: Federal Commission for Sanitary Risks Protection
010-08
NCT01410604
January 2007
March 2010
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