Clinical trial NCT01410604: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Keywords: Metformin
Obesity
Insulin resistance
Interleukin six
Adiponectin
High sensitivity C reactive protein.
Tumour Necrosis Factor alpha
Lead sponsor: Hospital Regional de Alta Especialidad del Bajio
Sponsor class: OTHER
Collaborators: name: Hospital Infantil de Mexico Federico Gomez
First posted: 2011-08-05
Enrollment: 31
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Adiponectin
timeFrame: baseline and 3 months
measure: High-sensitivity C-reactive Protein
timeFrame: baseline and 3 months
measure: Interleukin 6
timeFrame: baseline and 3 months
measure: Tumour Necrosis Factor Alpha
timeFrame: baseline and 3 months
Secondary outcomes:
measure: Fasting Plasma Glucose
timeFrame: baseline and 3 months
measure: Fasting Insulin
timeFrame: baseline and 3 months
measure: Body Mass Index
timeFrame: baseline and 3 months
measure: Waist Circumference
timeFrame: baseline and 3 months
Other outcomes:
Locations:
city: México
country: Mexico
facility: Hospital Infantil de México Federico Gómez
state: Distrito Federal
city: León
country: Mexico
facility: Hospital Regional de Alta Especialidad del Bajío
state: Guanajuato
Study officials:
affiliation: Hospital Regional de Alta Especialidad del Bajio
name: Maria L Evia-Viscarra, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Regional de Alta Especialidad del Bajio
name: Edel R Rodea-Montero, Statistician
role: STUDY_CHAIR
affiliation: Hospital Regional de Alta Especialidad del Bajio
name: Evelia Apolinar-Jiménez, Nutrition
role: STUDY_CHAIR
affiliation: Hospital Infantil de Mexico Federico Gomez
name: Leticia M García-Morales, M.D.
role: STUDY_CHAIR
affiliation: Hospital Infantil de Mexico Federico Gomez
name: Constanza Leaños-Pérez, M.D.
role: STUDY_CHAIR
affiliation: Hospital Infantil de Mexico Federico Gomez
name: Mireya Figueroa-Barrón, Chemestry
role: STUDY_CHAIR
affiliation: Hospital Infantil de Mexico Federico Gomez
name: Dolores Sánchez-Fierros, Chemestry
role: STUDY_CHAIR
affiliation: Hospital Regional de Alta Especialidad del Bajio
name: Nathalie Muñoz-Noriega, Nutrition
role: STUDY_CHAIR
affiliation: Escuela Superior de Medicina del IPN
name: Juan G Reyes-García, M.D.
role: STUDY_CHAIR
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