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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Obesity

Intervention / Treatment
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* Drug: metformin
* Dietary Supplement: Conjugated Linoleic Acid
* Drug: Placebo
* Behavioral: Healthy habits program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: metformin and healthy habits program<br>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<br>* 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.<br>Behavioral: Healthy habits program<br> <br> |
| Experimental: Conjugated Linoleic Acid and healthy habits<br>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<br>* 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.<br>Behavioral: Healthy habits program<br> <br> |
| Placebo Comparator: Placebo and healthy habits program<br>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<br>* 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<br>Behavioral: Healthy habits program<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 the phosphorylation of the insulin receptor in adipocytes 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 | 
| Number of Participants with Serious and Non-Serious Adverse Events |  | up to 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CLA, pediatric obesity, conjugated linoleic acid, metformin