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

Phase 4
9 Years
18 Years
Not Enrolling

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Trial Information

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

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

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

Change from baseline in Adiponectin after 3 months of treatment.

Outcome Time Frame:

baseline and 3 months

Safety Issue:


Principal Investigator

Maria L Evia-Viscarra, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital Regional de Alta Especialidad del Bajío


Mexico: Federal Commission for Sanitary Risks Protection

Study ID:




Start Date:

January 2007

Completion Date:

March 2010

Related Keywords:

  • Obesity
  • Metformin
  • Obesity
  • Insulin resistance
  • Interleukin six
  • Adiponectin
  • High sensitivity C reactive protein.
  • Tumour Necrosis Factor alpha
  • Insulin Resistance
  • Obesity