Metformin vs Conjugated Linoleic Acid and an Intervention Program With Healthy Habits in Obese Children

Phase 2UnknownNCT02063802

Laboratorios Silanes S.A. de C.V.120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Obesity

Interventions

metforminDRUG

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 AcidDIETARY_SUPPLEMENT

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.

PlaceboDRUG

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

Sex: ALLMin age: 8 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

General Hospital of Mexico

Mexico City, Mexico City, Mexico

RECRUITING