NCT01410604

Adipokines in Obese Adolescents With Insulin Resistance

Inflammatory Mediators in Obese Adolescents With Insulin Resistance Following Metformin Treatment: Controlled Randomized Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Hospital Regional de Alta Especialidad del Bajio · Academic / Other
• Sex: All
• Age: 9 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Metformin	Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months.
DRUG	Placebo	Tablet of 500 mg oral placebo every 12 hours for 3 months.

Timeline

• Start date: 2007-01-01
• Primary completion: 2009-12-01
• Completion: 2010-03-01
• First posted: 2011-08-05
• Last updated: 2012-04-27
• Results posted: 2012-04-23

Locations

2 sites across 1 country: Mexico