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

February 13, 2014 updated by: Laboratorios Silanes S.A. de C.V.

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 06726
        • Recruiting
        • General Hospital of Mexico
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: metformin and 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.
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.
Behavioral: Healthy habits program
Experimental: Conjugated Linoleic Acid and healthy habits
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.
Behavioral: Healthy habits program
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.
Placebo Comparator: Placebo and 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.
Behavioral: Healthy habits program
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in body mass index at 4 months
Time Frame: baseline, 4 months
baseline, 4 months
Change in body fat mass at 4 months
Time Frame: baseline, 4 months
baseline, 4 months
Change in lean body mass at 4 months
Time Frame: baseline, 4 months
baseline, 4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in clinical laboratory values at 4 months
Time Frame: baseline, 4 months
baseline, 4 months
Change in M Value in CLAMP at 4 months
Time Frame: baseline, 4 months
baseline, 4 months
Change in muscle tissue transcriptome at 4 months
Time Frame: baseline, 4 months
baseline, 4 months
Change in adipose tissue transcriptome at 4 months
Time Frame: baseline, 4 months
baseline, 4 months
Change in inflammatory cytokines al 4 months
Time Frame: baseline, 4 months
baseline, 4 months
Change in the phosphorylation of the insulin receptor in muscle tissue at 4 months
Time Frame: baseline, 4 months
baseline, 4 months
Change in the phosphorylation of the insulin receptor in adipocytes at 4 months
Time Frame: baseline, 4 months
baseline, 4 months
Change in activation status of proteins involved in insulin signaling of myocytes cDNA at 4 months
Time Frame: baseline, 4 months
baseline, 4 months
Number of Participants with Serious and Non-Serious Adverse Events
Time Frame: up to 4 months
up to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratorios Silanes S.A. de C.V.

Collaborators

Hospital General de Mexico

Investigators

  • Principal Investigator: Nayely G Garibay, Pediatrician, Hospital General de Mexico
  • Principal Investigator: Gloria E Queipo, M.Specialist, Hospital General de Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

May 1, 2014

Study Completion (Anticipated)

May 1, 2014

Study Registration Dates

First Submitted

February 12, 2014

First Submitted That Met QC Criteria

February 13, 2014

First Posted (Estimate)

February 14, 2014

Study Record Updates

Last Update Posted (Estimate)

February 14, 2014

Last Update Submitted That Met QC Criteria

February 13, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DI/11/311/04/108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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