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

Phase 2

• Conditions: Obesity
• Interventions: Dietary Supplement: Conjugated Linoleic Acid; Drug: Placebo; Drug: metformin; Behavioral: Healthy habits program

• Registration Number: NCT02063802
• Lead Sponsor: Laboratorios Silanes S.A. de C.V.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Status Verified: 2014-02
• Study First Submitted: 2014-02-12
• Study First Submitted QC: 2014-02-13
• Last Update Submitted: 2014-02-13
• Study First Posted: 2014-02-14
• Last Update Posted: 2014-02-14
• Primary Completion: 2014-05
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conjugated Linoleic Acid and healthy habits	Conjugated Linoleic Acid	Total dose: 3gr per day (500mg capsules). The patient takes 2 capsules with breakfast, 2 capsules with lunch and 2 capsules with dinner by mouth for four months.
metformin and healthy habits program	Healthy habits program	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.
Placebo and healthy habits program	Placebo	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.
Placebo and healthy habits program	Healthy habits program	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.
Conjugated Linoleic Acid and healthy habits	Healthy habits program	Total dose: 3gr per day (500mg capsules). The patient takes 2 capsules with breakfast, 2 capsules with lunch and 2 capsules with dinner by mouth for four months.
metformin and healthy habits program	metformin	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.

Primary Outcome Measures

Name	Time	Method
Change in body fat mass at 4 months	baseline, 4 months
Change from baseline in body mass index at 4 months	baseline, 4 months
Change in lean body mass at 4 months	baseline, 4 months

Secondary Outcome Measures

Name	Time	Method
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 clinical laboratory values 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
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 activation status of proteins involved in insulin signaling of myocytes cDNA at 4 months	baseline, 4 months

Trial Locations

Locations (1)

General Hospital of Mexico; 🇲🇽 Mexico, Distrito Federal, Mexico