Adipokines in Obese Adolescents With Insulin Resistance | RxWiki

Adipokines in Obese Adolescents With Insulin Resistance

Overview[ - collapse ][ - ]

Purpose	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).
Condition	Obesity
Intervention	Drug: Metformin Drug: Placebo
Phase	Phase 4
Sponsor	Hospital Regional de Alta Especialidad del Bajio
Responsible Party	Hospital Regional de Alta Especialidad del Bajio
ClinicalTrials.gov Identifier	NCT01410604
First Received	August 4, 2011
Last Updated	April 23, 2012
Last verified	April 2012

Tracking Information[ + expand ][ + ]

First Received Date	August 4, 2011
Last Updated Date	April 23, 2012
Start Date	January 2007
Estimated Primary Completion Date	March 2010
Current Primary Outcome Measures	Adiponectin [Time Frame: baseline and 3 months] [Designated as safety issue: Yes]Change from baseline in Adiponectin after 3 months of treatment. High-sensitivity C-reactive Protein [Time Frame: baseline and 3 months] [Designated as safety issue: Yes]Change from baseline in High-sensitivity C-reactive protein after 3 months of treatment. Interleukin 6 [Time Frame: baseline and 3 months] [Designated as safety issue: Yes]Change from baseline in Interleukin 6 after 3 months of treatment. Tumour Necrosis Factor Alpha [Time Frame: baseline and 3 months] [Designated as safety issue: Yes]Change from baseline in Tumour necrosis factor alpha after 3 months of treatment.
Current Secondary Outcome Measures	Fasting Plasma Glucose [Time Frame: baseline and 3 months] [Designated as safety issue: Yes]Change from baseline in Fasting plasma glucose after 3 months of treatment. Fasting Insulin [Time Frame: baseline and 3 months] [Designated as safety issue: Yes]Change from baseline in Fasting insulin after 3 months of treatment. Body Mass Index [Time Frame: baseline and 3 months] [Designated as safety issue: Yes]Change from baseline in Body Mass Index after 3 months of treatment. Waist Circumference [Time Frame: baseline and 3 months] [Designated as safety issue: Yes]Change from baseline in Waist circumference after 3 months of treatment.

Descriptive Information[ + expand ][ + ]

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
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.
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Obesity
Intervention	Drug: Metformin Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months. Other Names: DabexDrug: Placebo Tablet of 500 mg oral placebo every 12 hours for 3 months.
Study Arm (s)	Experimental: Metformin Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months. Placebo Comparator: Placebo Tablet of 500 mg oral placebo every 12 hours for 3 months.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	31
Estimated Completion Date	March 2010
Estimated Primary Completion Date	December 2009
Eligibility Criteria	Inclusion Criteria: - Obesity defined as Body Mass Index (BMI) ≥ percentile 95 - Tanner stage ≥ 2 - Insulin resistance defined as Basal insulin > 15 µU/mL or Homeostasis Model Assessment index (HOMA) > 4.5 - Patients' parents signed written consents when they and their adolescent children agreed to enroll Exclusion Criteria: - Glucose intolerance - Diabetes mellitus (type 1 or 2) - Anemia (Hb < 10 g/dL) - Plasma creatinine > 1.4 mg/dL - Abnormal hepatic function - Any associated Disease (Pulmonary, Infection, Autoimmune Disease) - History of lactic acidosis
Gender	Both
Ages	9 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Mexico

Administrative Information[ + expand ][ + ]

NCT Number	NCT01410604
Other Study ID Numbers	010-08
Has Data Monitoring Committee	No
Information Provided By	Hospital Regional de Alta Especialidad del Bajio
Study Sponsor	Hospital Regional de Alta Especialidad del Bajio
Collaborators	Hospital Infantil de Mexico Federico Gomez
Investigators	Principal Investigator: Maria L Evia-Viscarra, M.D. Hospital Regional de Alta Especialidad del BajíoStudy Chair: Edel R Rodea-Montero, Statistician Hospital Regional de Alta Especialidad del BajíoStudy Chair: Evelia Apolinar-Jiménez, Nutrition Hospital Regional de Alta Especialidad del BajíoStudy Chair: Leticia M García-Morales, M.D. Hospital Infantil de México Federico GómezStudy Chair: Constanza Leaños-Pérez, M.D. Hospital Infantil de México Federico GómezStudy Chair: Mireya Figueroa-Barrón, Chemestry Hospital Infantil de México Federico GómezStudy Chair: Dolores Sánchez-Fierros, Chemestry Hospital Infantil de México Federico GómezStudy Chair: Nathalie Muñoz-Noriega, Nutrition Hospital Regional de Alta Especialidad del BajíoStudy Chair: Juan G Reyes-García, M.D. Escuela Superior de Medicina del IPN
Verification Date	April 2012

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