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| Name | Class |
|---|---|
| Hospital General de Mexico | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| metformin and healthy habits program | Active Comparator | 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. |
|
| Conjugated Linoleic Acid and healthy habits | Experimental | 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. |
|
| Placebo and healthy habits program | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metformin | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jorge A Gonzalez, Director | Contact | 521 (55)54883761 | 3761 | jogonzalez@silanes.com.mx |
| Yulia Romero, Coordinator | Contact | 521 (55)54883700 | 3777 | Yromero@silanes.com.mx |
| Name | Affiliation | Role |
|---|---|---|
| Nayely G Garibay, Pediatrician | Hospital General de México | Principal Investigator |
| Gloria E Queipo, M.Specialist | Hospital General de México | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Mexico | Recruiting | Mexico City | Mexico City | 06726 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27778642 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 22, 2016 | |
| Reset | Aug 3, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 22, 2016 | Aug 3, 2016 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D044243 | Linoleic Acids, Conjugated |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D008041 |
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| Conjugated Linoleic Acid | Dietary Supplement | 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 | Drug | 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 |
|
| Healthy habits program | Behavioral |
|
| 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Linoleic Acids |
| D043371 | Fatty Acids, Omega-6 |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |