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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
31
Hospital Regional de Alta Especialidad del Bajío
León, Guanajuato, Mexico
Hospital Infantil de México Federico Gómez
Mexico City, Mexico City, Mexico
Adiponectin
Change from baseline in Adiponectin after 3 months of treatment.
Time frame: baseline and 3 months
High-sensitivity C-reactive Protein
Change from baseline in High-sensitivity C-reactive protein after 3 months of treatment.
Time frame: baseline and 3 months
Interleukin 6
Change from baseline in Interleukin 6 after 3 months of treatment.
Time frame: baseline and 3 months
Tumour Necrosis Factor Alpha
Change from baseline in Tumour necrosis factor alpha after 3 months of treatment.
Time frame: baseline and 3 months
Fasting Plasma Glucose
Change from baseline in Fasting plasma glucose after 3 months of treatment.
Time frame: baseline and 3 months
Fasting Insulin
Change from baseline in Fasting insulin after 3 months of treatment.
Time frame: baseline and 3 months
Body Mass Index
Change from baseline in Body Mass Index after 3 months of treatment.
Time frame: baseline and 3 months
Waist Circumference
Change from baseline in Waist circumference after 3 months of treatment.
Time frame: baseline and 3 months
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