Clinical trial NCT02063802: Metformin vs Conjugated Linoleic Acid and an Intervention Program With Healthy Habits in Obese Children
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Obesity
Keywords: pediatric obesity
conjugated linoleic acid
CLA
metformin
Lead sponsor: Laboratorios Silanes S.A. de C.V.
Sponsor class: INDUSTRY
Collaborators: name: Hospital General de Mexico
First posted: 2014-02-14
Enrollment: 120
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline in body mass index at 4 months
timeFrame: baseline, 4 months
measure: Change in body fat mass at 4 months
timeFrame: baseline, 4 months
measure: Change in lean body mass at 4 months
timeFrame: baseline, 4 months
Secondary outcomes:
measure: Change in clinical laboratory values at 4 months
timeFrame: baseline, 4 months
measure: Change in M Value in CLAMP at 4 months
timeFrame: baseline, 4 months
measure: Change in muscle tissue transcriptome at 4 months
timeFrame: baseline, 4 months
measure: Change in adipose tissue transcriptome at 4 months
timeFrame: baseline, 4 months
measure: Change in inflammatory cytokines al 4 months
timeFrame: baseline, 4 months
measure: Change in the phosphorylation of the insulin receptor in muscle tissue at 4 months
timeFrame: baseline, 4 months
measure: Change in the phosphorylation of the insulin receptor in adipocytes at 4 months
timeFrame: baseline, 4 months
measure: Change in activation status of proteins involved in insulin signaling of myocytes cDNA at 4 months
timeFrame: baseline, 4 months
measure: Number of Participants with Serious and Non-Serious Adverse Events
timeFrame: up to 4 months
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: General Hospital of Mexico
state: Distrito Federal
Study officials:
affiliation: Hospital General de México
name: Nayely G Garibay, Pediatrician
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital General de México
name: Gloria E Queipo, M.Specialist
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.