Adipokines in Obese Adolescents With Insulin Resistance
NCT ID: NCT01410604
Last Updated: 2012-04-27
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
31 participants
Study Classification
INTERVENTIONAL
Study Start Date
2007-01-31
Study Completion Date
2010-03-31
Brief Summary
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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).
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Detailed Description
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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.
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
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Obesity
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Metformin
Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months.
Group Type
EXPERIMENTAL
Metformin
Intervention Type
DRUG
Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months.
Placebo
Tablet of 500 mg oral placebo every 12 hours for 3 months.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Tablet of 500 mg oral placebo every 12 hours for 3 months.
Interventions
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Metformin
Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months.
Intervention Type
DRUG
Placebo
Tablet of 500 mg oral placebo every 12 hours for 3 months.
Intervention Type
DRUG
Other Intervention Names
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Dabex
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
9 Years
Maximum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Hospital Infantil de Mexico Federico Gomez
OTHER
Sponsor Role
collaborator
Hospital Regional de Alta Especialidad del Bajio
OTHER
Sponsor Role
lead
Responsible Party
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Maria Lola Evia-Viscarra
Pediatrics Endocrinology
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Maria L Evia-Viscarra, M.D.
Role: PRINCIPAL_INVESTIGATOR
Hospital Regional de Alta Especialidad del Bajio
Edel R Rodea-Montero, Statistician
Role: STUDY_CHAIR
Hospital Regional de Alta Especialidad del Bajio
Evelia Apolinar-Jiménez, Nutrition
Role: STUDY_CHAIR
Hospital Regional de Alta Especialidad del Bajio
Leticia M García-Morales, M.D.
Role: STUDY_CHAIR
Hospital Infantil de Mexico Federico Gomez
Constanza Leaños-Pérez, M.D.
Role: STUDY_CHAIR
Hospital Infantil de Mexico Federico Gomez
Mireya Figueroa-Barrón, Chemestry
Role: STUDY_CHAIR
Hospital Infantil de Mexico Federico Gomez
Dolores Sánchez-Fierros, Chemestry
Role: STUDY_CHAIR
Hospital Infantil de Mexico Federico Gomez
Nathalie Muñoz-Noriega, Nutrition
Role: STUDY_CHAIR
Hospital Regional de Alta Especialidad del Bajio
Juan G Reyes-García, M.D.
Role: STUDY_CHAIR
Escuela Superior de Medicina del IPN
Locations
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Hospital Regional de Alta Especialidad del Bajío
León, Guanajuato, Mexico
Site Status
Hospital Infantil de México Federico Gómez
Mexico City, Mexico City, Mexico
Site Status
Countries
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Mexico
References
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Centers for Disease Control and Prevention (CDC). CDC grand rounds: childhood obesity in the United States. MMWR Morb Mortal Wkly Rep. 2011 Jan 21;60(2):42-6.
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Reference Type
DERIVED
Other Identifiers
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010-08
Identifier Type: -
Identifier Source: org_study_id
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