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Trial record 27 of 193 for:    Oral Cancer | ( Map: Mexico )

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
Enrollment 31
Recruitment Details 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  
Arm/Group Title Metformin Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 15 16
Completed 12 14
Not Completed 3 2
Reason Not Completed
Adverse Event             2             1
Lost to Follow-up             1             0
Physician Decision             0             1
Arm/Group Title Metformin Placebo Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 15 16 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 31 participants
<=18 years
15
 100.0%
16
 100.0%
31
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 16 participants 31 participants
12.56  (2.25) 14.12  (1.20) 13.37  (1.92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 31 participants
Female
12
  80.0%
10
  62.5%
22
  71.0%
Male
3
  20.0%
6
  37.5%
9
  29.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Mexico Number Analyzed 15 participants 16 participants 31 participants
15 16 31
1.Primary Outcome
Title Adiponectin
Hide Description Change from baseline in Adiponectin after 3 months of treatment.
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 12 14
Mean (Standard Deviation)
Unit of Measure: µg/mL
-0.71  (4.29) -7.52  (6.28)
2.Primary Outcome
Title High-sensitivity C-reactive Protein
Hide Description Change from baseline in High-sensitivity C-reactive protein after 3 months of treatment.
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 12 14
Mean (Standard Deviation)
Unit of Measure: mg/dL
-1.26  (4.40) -1.35  (13.60)
3.Primary Outcome
Title Interleukin 6
Hide Description Change from baseline in Interleukin 6 after 3 months of treatment.
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 12 14
Mean (Standard Deviation)
Unit of Measure: pg/mL
-34.09  (145.72) 16.42  (60.50)
4.Primary Outcome
Title Tumour Necrosis Factor Alpha
Hide Description Change from baseline in Tumour necrosis factor alpha after 3 months of treatment.
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 12 14
Mean (Standard Deviation)
Unit of Measure: pg/mL
-34.08  (77.58) -4.01  (31.82)
5.Secondary Outcome
Title Fasting Plasma Glucose
Hide Description Change from baseline in Fasting plasma glucose after 3 months of treatment.
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 12 14
Mean (Standard Deviation)
Unit of Measure: mg/dL
-1.08  (11.39) 1.71  (15.61)
6.Secondary Outcome
Title Fasting Insulin
Hide Description Change from baseline in Fasting insulin after 3 months of treatment.
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 12 14
Mean (Standard Deviation)
Unit of Measure: µU/mL
-3.97  (23.28) 11.03  (14.37)
7.Secondary Outcome
Title Body Mass Index
Hide Description Change from baseline in Body Mass Index after 3 months of treatment.
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 12 14
Mean (Standard Deviation)
Unit of Measure: kg/m^2
-0.74  (0.83) -0.71  (0.85)
8.Secondary Outcome
Title Waist Circumference
Hide Description Change from baseline in Waist circumference after 3 months of treatment.
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 12 14
Mean (Standard Deviation)
Unit of Measure: cm
-0.57  (4.28) -3.29  (5.24)
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Metformin Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Metformin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Metformin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/15 (13.33%)      1/16 (6.25%)    
Gastrointestinal disorders     
Epigastric pain [1]  2/15 (13.33%)  2 1/16 (6.25%)  1
[1]
Adverse effect characterized by “ burning ” epigastric pain
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Metformin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/16 (0.00%)    
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: M.D. Maria L. Evia-Viscarra
Organization: Hospital Regional de Alta Especialidad del Bajio
Phone: +52 (477) 267-2000 ext 1405
EMail: 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
Layout table for additonal information
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