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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02063802
• Other study ID #: DI/11/311/04/108
• Status: Unknown status
• Phase: Phase 2
• First received: February 12, 2014
• Last updated: February 13, 2014
• Start date: August 2012
• Est. completion date: May 2014

Study information

• Verified date: February 2014
• Source: Laboratorios Silanes S.A. de C.V.
• Contact: Jorge A Gonzalez, Director
• Phone: 521 (55)54883761
• Email: jogonzalez[@]silanes.com.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 120
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• metformin
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 Supplement:
• Conjugated 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.

Drug:
• 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

Behavioral:
• Healthy habits program

Locations

Country	Name	City	State
Mexico	General Hospital of Mexico	Mexico	Distrito Federal

Sponsors (2)

Lead Sponsor	Collaborator
Laboratorios Silanes S.A. de C.V.	Hospital General de Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in body mass index at 4 months		baseline, 4 months
Primary	Change in body fat mass at 4 months		baseline, 4 months
Primary	Change in lean body mass at 4 months		baseline, 4 months
Secondary	Change in clinical laboratory values at 4 months		baseline, 4 months
Secondary	Change in M Value in CLAMP at 4 months		baseline, 4 months
Secondary	Change in muscle tissue transcriptome at 4 months		baseline, 4 months
Secondary	Change in adipose tissue transcriptome at 4 months		baseline, 4 months
Secondary	Change in inflammatory cytokines al 4 months		baseline, 4 months
Secondary	Change in the phosphorylation of the insulin receptor in muscle tissue at 4 months		baseline, 4 months
Secondary	Change in the phosphorylation of the insulin receptor in adipocytes at 4 months		baseline, 4 months
Secondary	Change in activation status of proteins involved in insulin signaling of myocytes cDNA at 4 months		baseline, 4 months
Secondary	Number of Participants with Serious and Non-Serious Adverse Events		up to 4 months