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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
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
Show Outcome Measure DataHide 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
Show Outcome Measure DataHide 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
Show Outcome Measure DataHide 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
Show Outcome Measure DataHide 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
Show Outcome Measure DataHide 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
Show Outcome Measure DataHide 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
Show Outcome Measure DataHide 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
Show Outcome Measure DataHide 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
Name/Title: M.D. Maria L. Evia-Viscarra
Organization: Hospital Regional de Alta Especialidad del Bajio
Phone: +52 (477) 267-2000 ext 1405
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
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