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

Primary Purpose

Obesity

Status
Unknown status
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
metformin
Conjugated Linoleic Acid
Placebo
Healthy habits program
Sponsored by
Laboratorios Silanes S.A. de C.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring pediatric obesity, conjugated linoleic acid, CLA, metformin

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • General Hospital of MexicoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

metformin and healthy habits program

Conjugated Linoleic Acid and healthy habits

Placebo and healthy habits program

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in body mass index at 4 months
Change in body fat mass at 4 months
Change in lean body mass at 4 months

Secondary Outcome Measures

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

Full Information

First Posted
February 12, 2014
Last Updated
February 13, 2014
Sponsor
Laboratorios Silanes S.A. de C.V.
Collaborators
Hospital General de Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT02063802
Brief Title
Metformin vs Conjugated Linoleic Acid and an Intervention Program With Healthy Habits in Obese Children
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Silanes S.A. de C.V.
Collaborators
Hospital General de Mexico

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
pediatric obesity, conjugated linoleic acid, CLA, metformin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
metformin and healthy habits program
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Conjugated Linoleic Acid and healthy habits
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo and healthy habits program
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Conjugated Linoleic Acid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Healthy habits program
Primary Outcome Measure Information:
Title
Change from baseline in body mass index at 4 months
Time Frame
baseline, 4 months
Title
Change in body fat mass at 4 months
Time Frame
baseline, 4 months
Title
Change in lean body mass at 4 months
Time Frame
baseline, 4 months
Secondary Outcome Measure Information:
Title
Change in clinical laboratory values at 4 months
Time Frame
baseline, 4 months
Title
Change in M Value in CLAMP at 4 months
Time Frame
baseline, 4 months
Title
Change in muscle tissue transcriptome at 4 months
Time Frame
baseline, 4 months
Title
Change in adipose tissue transcriptome at 4 months
Time Frame
baseline, 4 months
Title
Change in inflammatory cytokines al 4 months
Time Frame
baseline, 4 months
Title
Change in the phosphorylation of the insulin receptor in muscle tissue at 4 months
Time Frame
baseline, 4 months
Title
Change in the phosphorylation of the insulin receptor in adipocytes at 4 months
Time Frame
baseline, 4 months
Title
Change in activation status of proteins involved in insulin signaling of myocytes cDNA at 4 months
Time Frame
baseline, 4 months
Title
Number of Participants with Serious and Non-Serious Adverse Events
Time Frame
up to 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jorge A Gonzalez, Director
Phone
521 (55)54883761
Ext
3761
Email
jogonzalez@silanes.com.mx
First Name & Middle Initial & Last Name or Official Title & Degree
Yulia Romero, Coordinator
Phone
521 (55)54883700
Ext
3777
Email
Yromero@silanes.com.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nayely G Garibay, Pediatrician
Organizational Affiliation
Hospital General de México
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gloria E Queipo, M.Specialist
Organizational Affiliation
Hospital General de México
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital of Mexico
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06726
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nayely G Garibay, Pediatrician
Phone
+52 (55) 59-48-26-37
Email
gngaribay@hotmail.com
First Name & Middle Initial & Last Name & Degree
Mayra A Bustos, Doctor
Phone
+52 7773406509
Email
mayibe2609@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
27778642
Citation
Garibay-Nieto N, Queipo-Garcia G, Alvarez F, Bustos M, Villanueva E, Ramirez F, Leon M, Laresgoiti-Servitje E, Duggirala R, Macias T, Cuevas S, Jalife A, Fonseca-Sanchez M, Serratos F, Lopez-Alvarenga JC. Effects of Conjugated Linoleic Acid and Metformin on Insulin Sensitivity in Obese Children: Randomized Clinical Trial. J Clin Endocrinol Metab. 2017 Jan 1;102(1):132-140. doi: 10.1210/jc.2016-2701.
Results Reference
derived

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

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