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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02063802

Enrollment

120

Registered

2014-02-14

Start date

2012-08-31

Completion date

2014-05-31

Last updated

2014-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

pediatric obesity, conjugated linoleic acid, CLA, metformin

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.

Interventions

DRUGmetformin

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.

DIETARY_SUPPLEMENTConjugated 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.

DRUGPlacebo

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

BEHAVIORALHealthy habits program

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

8 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Change in adipose tissue transcriptome at 4 months	baseline, 4 months
Change in inflammatory cytokines al 4 months	baseline, 4 months
Change in the phosphorylation of the insulin receptor in muscle tissue at 4 months	baseline, 4 months
Change in clinical laboratory values at 4 months	baseline, 4 months
Change in activation status of proteins involved in insulin signaling of myocytes cDNA at 4 months	baseline, 4 months
Number of Participants with Serious and Non-Serious Adverse Events	up to 4 months
Change in the phosphorylation of the insulin receptor in adipocytes 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

Countries

Mexico

Contacts

Primary ContactJorge A Gonzalez, Director

jogonzalez@silanes.com.mx521 (55)54883761

Backup ContactYulia Romero, Coordinator

Yromero@silanes.com.mx521 (55)54883700

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026