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Spots Global Cancer Trial Database for Adipokines in Obese Adolescents With Insulin Resistance

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Trial Identification

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

Conditions

Obesity

Interventions

Metformin
Placebo

Study Description

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.

Eligibility

Minimum Age: 9 Years

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Hospital Infantil de México Federico Gómez, México, Distrito Federal, Mexico

Hospital Regional de Alta Especialidad del Bajío, León, Guanajuato, Mexico

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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