Metformin vs Conjugated Linoleic Acid and an Intervention Program With Healthy Habits in Obese Children
NCT ID: NCT02063802
Last Updated: 2014-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
120 participants
INTERVENTIONAL
2012-08-31
2014-05-31
Brief Summary
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Patients from the pediatric service of the Hospital from 8 to 18 years old with a body mass index ≥ Pc 95 and 35kg/m2 are randomized to either interventional group for 4 months.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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metformin and healthy habits program
1 gr per day. (250mg tablets). The patient takes 2 tablets with breakfast and 2 tablets with dinner and 2 placebo tablets with food by mouth for four months.
metformin
total dose: 1 gr per day (250mg tablets). The patient takes 2 tablets with breakfast and 2 tablets with dinner and 2 placebo tablets with food by mouth for four months.
Healthy habits program
Conjugated Linoleic Acid and healthy habits
Total dose: 3gr per day (500mg capsules). The patient takes 2 capsules with breakfast, 2 capsules with lunch and 2 capsules with dinner by mouth for four months.
Conjugated Linoleic Acid
total dose: 3gr/día(500mg capsules). The patient takes 2 capsules with breakfast, 2 capsules with lunch and 2 capsules with dinner for four months.
Healthy habits program
Placebo and healthy habits program
Total dose 6 tablets per day. The patient takes 2 tablets with breakfast, two tablets with lunch and two tablets with dinner by mouth for four months.
Placebo
Total dose 6 tablets per day. The patient takes 2 tablets with breakfast, two tablets with lunch and two tablets with dinner by mouth for four months
Healthy habits program
Interventions
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metformin
total dose: 1 gr per day (250mg tablets). The patient takes 2 tablets with breakfast and 2 tablets with dinner and 2 placebo tablets with food by mouth for four months.
Conjugated Linoleic Acid
total dose: 3gr/día(500mg capsules). The patient takes 2 capsules with breakfast, 2 capsules with lunch and 2 capsules with dinner for four months.
Placebo
Total dose 6 tablets per day. The patient takes 2 tablets with breakfast, two tablets with lunch and two tablets with dinner by mouth for four months
Healthy habits program
Eligibility Criteria
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Inclusion Criteria
* Pc BMI ≥ 95 and \<35kg/m2,
* No endocrine diseases, including diabetes mellitus
* No systemic diseases
* No genetic diseases
* No pharmacological treatment affecting lipid metabolism or glucose
* No history of acute or prolonged immobilization
* Normal aminotransferases
* Signed Informed consent and assent
8 Years
18 Years
ALL
No
Sponsors
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Hospital General de Mexico
OTHER_GOV
Laboratorios Silanes S.A. de C.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Nayely G Garibay, Pediatrician
Role: PRINCIPAL_INVESTIGATOR
Hospital General de México
Gloria E Queipo, M.Specialist
Role: PRINCIPAL_INVESTIGATOR
Hospital General de México
Locations
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General Hospital of Mexico
Mexico City, Mexico City, Mexico
Countries
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Central Contacts
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Facility Contacts
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References
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Garibay-Nieto N, Queipo-Garcia G, Alvarez F, Bustos M, Villanueva E, Ramirez F, Leon M, Laresgoiti-Servitje E, Duggirala R, Macias T, Cuevas S, Jalife A, Fonseca-Sanchez M, Serratos F, Lopez-Alvarenga JC. Effects of Conjugated Linoleic Acid and Metformin on Insulin Sensitivity in Obese Children: Randomized Clinical Trial. J Clin Endocrinol Metab. 2017 Jan 1;102(1):132-140. doi: 10.1210/jc.2016-2701.
Other Identifiers
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DI/11/311/04/108
Identifier Type: -
Identifier Source: org_study_id
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