Metformin vs Conjugated Linoleic Acid and an Intervention Program With Healthy Habits in Obese Children
Effect of an Intervention Program With Healthy Habits Plus Metformin or Conjugated Linoleic Acid Over Clinical Parameters and Molecular Pathways of Insulin Resistance in Obese Pediatric Patients
1 other identifier
interventional
120
1 country
1
Brief Summary
The purpose of this clinical trial is to examine the effects of conjugated linoleic acid (CLA) vs metformin along with an intervention program with healthy habits on body composition, weight, M value in CLAMP and clinical laboratory values, as well as molecular and genetic changes in obese children. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 obesity
Started Aug 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 12, 2014
CompletedFirst Posted
Study publicly available on registry
February 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedFebruary 14, 2014
February 1, 2014
1.7 years
February 12, 2014
February 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change from baseline in body mass index at 4 months
baseline, 4 months
Change in body fat mass at 4 months
baseline, 4 months
Change in lean body mass at 4 months
baseline, 4 months
Secondary Outcomes (9)
Change in clinical laboratory values at 4 months
baseline, 4 months
Change in M Value in CLAMP at 4 months
baseline, 4 months
Change in muscle tissue transcriptome at 4 months
baseline, 4 months
Change in adipose tissue transcriptome at 4 months
baseline, 4 months
Change in inflammatory cytokines al 4 months
baseline, 4 months
- +4 more secondary outcomes
Study Arms (3)
metformin and healthy habits program
ACTIVE COMPARATOR1 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 and healthy habits
EXPERIMENTALTotal 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.
Placebo and healthy habits program
PLACEBO COMPARATORTotal 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.
Interventions
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.
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.
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
Eligibility Criteria
You may qualify if:
- Patients of both sexes between 8 and 18 years old
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laboratorios Silanes S.A. de C.V.lead
- Hospital General de Mexicocollaborator
Study Sites (1)
General Hospital of Mexico
Mexico City, Mexico City, 06726, Mexico
Related Publications (1)
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.
PMID: 27778642DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nayely G Garibay, Pediatrician
Hospital General de México
- PRINCIPAL INVESTIGATOR
Gloria E Queipo, M.Specialist
Hospital General de México
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2014
First Posted
February 14, 2014
Study Start
August 1, 2012
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
February 14, 2014
Record last verified: 2014-02