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Completed

NCT Number: NCT01410604

Adipokines in Obese Adolescents With Insulin Resistance

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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Key information

Age range

9 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months.

Other names: Dabex

Placebo

Drug

Tablet of 500 mg oral placebo every 12 hours for 3 months.

Primary outcomes

  1. Adiponectin

    Time frame: baseline and 3 months

    Change from baseline in Adiponectin after 3 months of treatment.

  2. High-sensitivity C-reactive Protein

    Time frame: baseline and 3 months

    Change from baseline in High-sensitivity C-reactive protein after 3 months of treatment.

  3. Interleukin 6

    Time frame: baseline and 3 months

    Change from baseline in Interleukin 6 after 3 months of treatment.

  4. Tumour Necrosis Factor Alpha

    Time frame: baseline and 3 months

    Change from baseline in Tumour necrosis factor alpha after 3 months of treatment.

Secondary outcomes

  1. Fasting Plasma Glucose

    Time frame: baseline and 3 months

    Change from baseline in Fasting plasma glucose after 3 months of treatment.

  2. Fasting Insulin

    Time frame: baseline and 3 months

    Change from baseline in Fasting insulin after 3 months of treatment.

  3. Body Mass Index

    Time frame: baseline and 3 months

    Change from baseline in Body Mass Index after 3 months of treatment.

  4. Waist Circumference

    Time frame: baseline and 3 months

    Change from baseline in Waist circumference after 3 months of treatment.

Sponsors and collaborators

Lead sponsor

Hospital Regional de Alta Especialidad del Bajio

Other

Collaborators

  • Hospital Infantil de Mexico Federico Gomez

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Aug 5, 2011
Registry last updated
Apr 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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