Overview

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

Status:
Unknown status
Trial end date:
2014-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Laboratorios Silanes S.A. de C.V.
Collaborator:
Hospital General de Mexico
Treatments:
Metformin
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