Adipokines in Obese Adolescents With Insulin Resistance

April 23, 2012 updated by: Maria Lola Evia-Viscarra, Hospital Regional de Alta Especialidad del Bajio

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

31

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Distrito Federal
      • México, Distrito Federal, Mexico, 06720
        • Hospital Infantil de Mexico Federico Gomez
    • Guanajuato
      • León, Guanajuato, Mexico, 37670
        • Hospital Regional de Alta Especialidad del Bajio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metformin
Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months.
Drug: Metformin
Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months.
Other Names:
  • Dabex
Placebo Comparator: Placebo
Tablet of 500 mg oral placebo every 12 hours for 3 months.
Drug: Placebo
Tablet of 500 mg oral placebo every 12 hours for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adiponectin
Time Frame: baseline and 3 months
Change from baseline in Adiponectin after 3 months of treatment.
baseline and 3 months
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.
baseline and 3 months
Interleukin 6
Time Frame: baseline and 3 months
Change from baseline in Interleukin 6 after 3 months of treatment.
baseline and 3 months
Tumour Necrosis Factor Alpha
Time Frame: baseline and 3 months
Change from baseline in Tumour necrosis factor alpha after 3 months of treatment.
baseline and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting Plasma Glucose
Time Frame: baseline and 3 months
Change from baseline in Fasting plasma glucose after 3 months of treatment.
baseline and 3 months
Fasting Insulin
Time Frame: baseline and 3 months
Change from baseline in Fasting insulin after 3 months of treatment.
baseline and 3 months
Body Mass Index
Time Frame: baseline and 3 months
Change from baseline in Body Mass Index after 3 months of treatment.
baseline and 3 months
Waist Circumference
Time Frame: baseline and 3 months
Change from baseline in Waist circumference after 3 months of treatment.
baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this 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 Bajio
  • Study Chair: Edel R Rodea-Montero, Statistician, Hospital Regional de Alta Especialidad del Bajio
  • Study Chair: Evelia Apolinar-Jiménez, Nutrition, Hospital Regional de Alta Especialidad del Bajio
  • Study Chair: Leticia M García-Morales, M.D., Hospital Infantil de Mexico Federico Gomez
  • Study Chair: Constanza Leaños-Pérez, M.D., Hospital Infantil de Mexico Federico Gomez
  • Study Chair: Mireya Figueroa-Barrón, Chemestry, Hospital Infantil de Mexico Federico Gomez
  • Study Chair: Dolores Sánchez-Fierros, Chemestry, Hospital Infantil de Mexico Federico Gomez
  • Study Chair: Nathalie Muñoz-Noriega, Nutrition, Hospital Regional de Alta Especialidad del Bajio
  • Study Chair: Juan G Reyes-García, M.D., Escuela Superior de Medicina del IPN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

August 4, 2011

First Submitted That Met QC Criteria

August 4, 2011

First Posted (Estimate)

August 5, 2011

Study Record Updates

Last Update Posted (Estimate)

April 27, 2012

Last Update Submitted That Met QC Criteria

April 23, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 010-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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