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