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Trial record 7 of 37 for:    conjugated linoleic acid

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

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ClinicalTrials.gov Identifier: NCT02063802
Recruitment Status : Unknown
Verified February 2014 by Laboratorios Silanes S.A. de C.V..
Recruitment status was:  Recruiting
First Posted : February 14, 2014
Last Update Posted : February 14, 2014
Sponsor:
Collaborator:
Hospital General de Mexico
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Obesity Drug: metformin Dietary Supplement: Conjugated Linoleic Acid Drug: Placebo Behavioral: Healthy habits program Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : August 2012
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


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.
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.

Behavioral: Healthy habits program
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.
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



Primary Outcome Measures :
  1. Change from baseline in body mass index at 4 months [ Time Frame: baseline, 4 months ]
  2. Change in body fat mass at 4 months [ Time Frame: baseline, 4 months ]
  3. Change in lean body mass at 4 months [ Time Frame: baseline, 4 months ]

Secondary Outcome Measures :
  1. Change in clinical laboratory values at 4 months [ Time Frame: baseline, 4 months ]
  2. Change in M Value in CLAMP at 4 months [ Time Frame: baseline, 4 months ]
  3. Change in muscle tissue transcriptome at 4 months [ Time Frame: baseline, 4 months ]
  4. Change in adipose tissue transcriptome at 4 months [ Time Frame: baseline, 4 months ]
  5. Change in inflammatory cytokines al 4 months [ Time Frame: baseline, 4 months ]
  6. Change in the phosphorylation of the insulin receptor in muscle tissue at 4 months [ Time Frame: baseline, 4 months ]
  7. Change in the phosphorylation of the insulin receptor in adipocytes at 4 months [ Time Frame: baseline, 4 months ]
  8. Change in activation status of proteins involved in insulin signaling of myocytes cDNA at 4 months [ Time Frame: baseline, 4 months ]
  9. Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: up to 4 months ]


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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02063802


Contacts
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Contact: Jorge A Gonzalez, Director 521 (55)54883761 ext 3761 jogonzalez@silanes.com.mx
Contact: Yulia Romero, Coordinator 521 (55)54883700 ext 3777 Yromero@silanes.com.mx

Locations
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Mexico
General Hospital of Mexico Recruiting
Mexico, Distrito Federal, Mexico, 06726
Contact: Nayely G Garibay, Pediatrician    +52 (55) 59-48-26-37    gngaribay@hotmail.com   
Contact: Mayra A Bustos, Doctor    +52 7773406509    mayibe2609@gmail.com   
Sponsors and Collaborators
Laboratorios Silanes S.A. de C.V.
Hospital General de Mexico
Investigators
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Principal Investigator: Nayely G Garibay, Pediatrician Hospital General de México
Principal Investigator: Gloria E Queipo, M.Specialist Hospital General de México

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Laboratorios Silanes S.A. de C.V.
ClinicalTrials.gov Identifier: NCT02063802     History of Changes
Other Study ID Numbers: DI/11/311/04/108
First Posted: February 14, 2014    Key Record Dates
Last Update Posted: February 14, 2014
Last Verified: February 2014
Keywords provided by Laboratorios Silanes S.A. de C.V.:
pediatric obesity
conjugated linoleic acid
CLA
metformin
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs