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Adipokines in Obese Adolescents With Insulin Resistance

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ClinicalTrials.gov Identifier: NCT01410604
Recruitment Status : Completed
First Posted : August 5, 2011
Results First Posted : April 23, 2012
Last Update Posted : April 27, 2012
Sponsor:
Collaborator:
Hospital Infantil de Mexico Federico Gomez
Information provided by (Responsible Party):
Maria Lola Evia-Viscarra, Hospital Regional de Alta Especialidad del Bajio

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Obesity
Interventions: Drug: Metformin
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled between January 2007 and December 2009 in the Pediatric Obesity Clinics (POC) from third level Mexican Hospitals: the HMFG, located in the Federal District (country’s capital), and the HRAEB, located in the city of Leon in the state of Guanajauto.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Metformin No text entered.
Placebo No text entered.

Participant Flow:   Overall Study
    Metformin   Placebo
STARTED   15   16 
COMPLETED   12   14 
NOT COMPLETED   3   2 
Adverse Event                2                1 
Lost to Follow-up                1                0 
Physician Decision                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Metformin No text entered.
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
   Metformin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   16   31 
Age 
[Units: Participants]
     
<=18 years   15   16   31 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 12.56  (2.25)   14.12  (1.20)   13.37  (1.92) 
Gender 
[Units: Participants]
     
Female   12   10   22 
Male   3   6   9 
Region of Enrollment 
[Units: Participants]
     
Mexico   15   16   31 


  Outcome Measures

1.  Primary:   Adiponectin   [ Time Frame: baseline and 3 months ]

2.  Primary:   High-sensitivity C-reactive Protein   [ Time Frame: baseline and 3 months ]

3.  Primary:   Interleukin 6   [ Time Frame: baseline and 3 months ]

4.  Primary:   Tumour Necrosis Factor Alpha   [ Time Frame: baseline and 3 months ]

5.  Secondary:   Fasting Plasma Glucose   [ Time Frame: baseline and 3 months ]

6.  Secondary:   Fasting Insulin   [ Time Frame: baseline and 3 months ]

7.  Secondary:   Body Mass Index   [ Time Frame: baseline and 3 months ]

8.  Secondary:   Waist Circumference   [ Time Frame: baseline and 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
During the recruitment phase, 83 children who were diagnosed with obesity and acanthosis nigricans were evaluated. Of these, 45 did not have the insulin concentration values (>15 µU/mL) required to biochemically define Insulin Resistance.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: M.D. Maria L. Evia-Viscarra
Organization: Hospital Regional de Alta Especialidad del Bajio
phone: +52 (477) 267-2000 ext 1405
e-mail: evialola@hotmail.com


Publications:
Perea-Martinez A, Carbajal R.L, Rodriguez H.R, Zarco R.J, Barrios F.R, Loredo A.A, et al. Association of comorbidity with obesity in mexican children and adolescents. Pediatrics 2008;121(2):S149-S150

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

Responsible Party: Maria Lola Evia-Viscarra, Hospital Regional de Alta Especialidad del Bajio
ClinicalTrials.gov Identifier: NCT01410604     History of Changes
Other Study ID Numbers: 010-08
First Submitted: August 4, 2011
First Posted: August 5, 2011
Results First Submitted: March 29, 2012
Results First Posted: April 23, 2012
Last Update Posted: April 27, 2012