Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Immune System Diseases

Obesity

Necrosis

Hypersensitivity

Insulin Resistance

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

Hypoglycemic Agents

All Drugs and Chemicals

Insulin

Insulin, Globin Zinc

Metformin

Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months.

Tablet of 500 mg oral placebo every 12 hours for 3 months.

Placebo

Maria L Evia-Viscarra, M.D.

Edel R Rodea-Montero, Statistician

Evelia Apolinar-Jiménez, Nutrition

Leticia M García-Morales, M.D.

Constanza Leaños-Pérez, M.D.

Mireya Figueroa-Barrón, Chemestry

Dolores Sánchez-Fierros, Chemestry

Nathalie Muñoz-Noriega, Nutrition

Juan G Reyes-García, M.D.

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.

Adipokines in Obese Adolescents With Insulin Resistance

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

Change from baseline in Adiponectin after 3 months of treatment.

Change from baseline in High-sensitivity C-reactive protein after 3 months of treatment.

Change from baseline in Interleukin 6 after 3 months of treatment.

Change from baseline in Tumour necrosis factor alpha after 3 months of treatment.

Change from baseline in Fasting plasma glucose after 3 months of treatment.

Change from baseline in Fasting insulin after 3 months of treatment.

Change from baseline in Body Mass Index after 3 months of treatment.

Change from baseline in Waist circumference after 3 months of treatment.

Hospital Infantil de Mexico Federico Gomez

Hospital Regional de Alta Especialidad del Bajio

Pediatrics Endocrinology

Total

Age, Categorical

Age Continuous

Sex: Female, Male

Mexico

Region of Enrollment

During the recruitment phase, 83 children who were diagnosed with obesity and acanthosis nigricans were evaluated. Of these, 45 did not have the insulin concentration values (\>15 µU/mL) required to biochemically define Insulin Resistance.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adipokines in Obese Adolescents With Insulin Resistance	NCT01410604	Obesity	Metformin Placebo	9 Years - 18 Years	Hospital Regional de Alta Especialidad del Bajio
Adipokines in Obese Adolescents With Insulin Resistance	NCT01410604	Obesity	Metformin Placebo	9 Years - 18 Years	Hospital Regional de Alta Especialidad del Bajio
Adipokines in Obese Adolescents With Insulin Resistance	NCT01410604	Obesity	Metformin Placebo	9 Years - 18 Years	Hospital Regional de Alta Especialidad del Bajio

Spots Global Cancer Trial Database for high sensitivity c reactive protein.