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Adipokines in Obese Adolescents With Insulin Resistance

This study has been completed.
Sponsor:
Collaborator:
Hospital Infantil de Mexico Federico Gomez
Information provided by (Responsible Party):
Maria Lola Evia-Viscarra, Hospital Regional de Alta Especialidad del Bajio
ClinicalTrials.gov Identifier:
NCT01410604
First received: August 4, 2011
Last updated: April 23, 2012
Last verified: April 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Obesity
 Drug: Metformin
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Inflammatory Mediators in Obese Adolescents With Insulin Resistance Following Metformin Treatment: Controlled Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Regional de Alta Especialidad del Bajio:

Primary Outcome Measures:
  • Adiponectin [ Time Frame: baseline and 3 months ] [ Designated as safety issue: Yes ]
    Change from baseline in Adiponectin after 3 months of treatment.

  • High-sensitivity C-reactive Protein [ Time Frame: baseline and 3 months ] [ Designated as safety issue: Yes ]
    Change from baseline in High-sensitivity C-reactive protein after 3 months of treatment.

  • Interleukin 6 [ Time Frame: baseline and 3 months ] [ Designated as safety issue: Yes ]
    Change from baseline in Interleukin 6 after 3 months of treatment.

  • Tumour Necrosis Factor Alpha [ Time Frame: baseline and 3 months ] [ Designated as safety issue: Yes ]
    Change from baseline in Tumour necrosis factor alpha after 3 months of treatment.


Secondary Outcome Measures:
  • Fasting Plasma Glucose [ Time Frame: baseline and 3 months ] [ Designated as safety issue: Yes ]
    Change from baseline in Fasting plasma glucose after 3 months of treatment.

  • Fasting Insulin [ Time Frame: baseline and 3 months ] [ Designated as safety issue: Yes ]
    Change from baseline in Fasting insulin after 3 months of treatment.

  • Body Mass Index [ Time Frame: baseline and 3 months ] [ Designated as safety issue: Yes ]
    Change from baseline in Body Mass Index after 3 months of treatment.

  • Waist Circumference [ Time Frame: baseline and 3 months ] [ Designated as safety issue: Yes ]
    Change from baseline in Waist circumference after 3 months of treatment.


Enrollment: 31
Study Start Date: January 2007
Study Completion Date: March 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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

Ages Eligible for Study:   9 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01410604

Locations
Mexico
Hospital Infantil de México Federico Gómez
México, Distrito Federal, Mexico, 06720
Hospital Regional de Alta Especialidad del Bajío
León, Guanajuato, Mexico, 37670
Sponsors and Collaborators
Hospital Regional de Alta Especialidad del Bajio
Hospital Infantil de Mexico Federico Gomez
Investigators
Principal Investigator: Maria L Evia-Viscarra, M.D. Hospital Regional de Alta Especialidad del Bajío
Study Chair: Edel R Rodea-Montero, Statistician Hospital Regional de Alta Especialidad del Bajío
Study Chair: Evelia Apolinar-Jiménez, Nutrition Hospital Regional de Alta Especialidad del Bajío
Study Chair: Leticia M García-Morales, M.D. Hospital Infantil de México Federico Gómez
Study Chair: Constanza Leaños-Pérez, M.D. Hospital Infantil de México Federico Gómez
Study Chair: Mireya Figueroa-Barrón, Chemestry Hospital Infantil de México Federico Gómez
Study Chair: Dolores Sánchez-Fierros, Chemestry Hospital Infantil de México Federico Gómez
Study Chair: Nathalie Muñoz-Noriega, Nutrition Hospital Regional de Alta Especialidad del Bajío
Study Chair: Juan G Reyes-García, M.D. Escuela Superior de Medicina del IPN
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Maria Lola Evia-Viscarra, Pediatrics Endocrinology, Hospital Regional de Alta Especialidad del Bajio
ClinicalTrials.gov Identifier: NCT01410604     History of Changes
Other Study ID Numbers: 010-08
Study First Received: August 4, 2011
Results First Received: March 29, 2012
Last Updated: April 23, 2012
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection

Keywords provided by Hospital Regional de Alta Especialidad del Bajio:
Metformin
Obesity
Insulin resistance
Interleukin six
 Adiponectin
High sensitivity C reactive protein.
Tumour Necrosis Factor alpha

Additional relevant MeSH terms:
Insulin Resistance
Obesity
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
 Body Weight
Signs and Symptoms
Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013