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| Name | Class |
|---|---|
| Hospital Infantil de Mexico Federico Gomez | OTHER |
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The purpose of this study is to compare serum concentrations of inflammatory cytokines, interleukin 6 (IL-6), High-sensitivity C-reactive protein (hs-CRP), adiponectin, and tumour necrosis factor alpha (TNFα), before and after three months treatment with metformin in obese adolescents with insulin resistance (IR).
The increased prevalence of obesity in pediatric patients is a public health problem particularly because of the difficulties involved with changing lifestyles. Current studies of obese children and adolescents show increased insulin resistance (IR) and chronic inflammatory states. These conditions increase the risk of disability and/or premature death.
The current treatment schemes for obese children are conservative and are focused on changing their lifestyles (exercise and dietary plans). However, metabolic conditions, such as IR, dyslipidemia, and inflammatory processes, are perpetuated.
Metformin is a biguanide that is used for adolescents with diabetes mellitus and polycystic ovarian syndrome. Several clinical trials with metformin for obese pediatric patients have observed decreases in IR, decreases in weight, and improvements in lipid metabolism.
Adipose tissue is not only an energy repository, but also plays an immunological role by the secretion of cytokines. Both overweight adults and adolescents show decreases in adiponectin levels and increases in tumor necrosis factor alpha (TNFα) and interleukin 6 (IL-6). IL-6 can stimulate the production of high-sensitivity C-reactive protein (hs-CRP), which is considered to be a risk marker for the development of cardiovascular disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Experimental | Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months. |
|
| Placebo | Placebo Comparator | Tablet of 500 mg oral placebo every 12 hours for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adiponectin | Change from baseline in Adiponectin after 3 months of treatment. | baseline and 3 months |
| High-sensitivity C-reactive Protein | Change from baseline in High-sensitivity C-reactive protein after 3 months of treatment. | baseline and 3 months |
| Interleukin 6 | Change from baseline in Interleukin 6 after 3 months of treatment. | baseline and 3 months |
| Tumour Necrosis Factor Alpha | Change from baseline in Tumour necrosis factor alpha after 3 months of treatment. | baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Plasma Glucose | Change from baseline in Fasting plasma glucose after 3 months of treatment. | baseline and 3 months |
| Fasting Insulin | Change from baseline in Fasting insulin after 3 months of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria L Evia-Viscarra, M.D. | Hospital Regional de Alta Especialidad del Bajio | Principal Investigator |
| Edel R Rodea-Montero, Statistician | Hospital Regional de Alta Especialidad del Bajio | Study Chair |
| Evelia Apolinar-Jiménez, Nutrition | Hospital Regional de Alta Especialidad del Bajio | Study Chair |
| Leticia M García-Morales, M.D. | Hospital Infantil de Mexico Federico Gomez | Study Chair |
| Constanza Leaños-Pérez, M.D. | Hospital Infantil de Mexico Federico Gomez | Study Chair |
| Mireya Figueroa-Barrón, Chemestry | Hospital Infantil de Mexico Federico Gomez | Study Chair |
| Dolores Sánchez-Fierros, Chemestry | Hospital Infantil de Mexico Federico Gomez | Study Chair |
| Nathalie Muñoz-Noriega, Nutrition | Hospital Regional de Alta Especialidad del Bajio | Study Chair |
| Juan G Reyes-García, M.D. | Escuela Superior de Medicina del IPN |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Regional de Alta Especialidad del Bajío | León | Guanajuato | 37670 | Mexico | ||
| Hospital Infantil de México Federico Gómez |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21248681 | Background | Centers for Disease Control and Prevention (CDC). CDC grand rounds: childhood obesity in the United States. MMWR Morb Mortal Wkly Rep. 2011 Jan 21;60(2):42-6. | |
| 17845100 | Background | Wilfley DE, Tibbs TL, Van Buren DJ, Reach KP, Walker MS, Epstein LH. Lifestyle interventions in the treatment of childhood overweight: a meta-analytic review of randomized controlled trials. Health Psychol. 2007 Sep;26(5):521-32. doi: 10.1037/0278-6133.26.5.521. |
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Subjects were enrolled between January 2007 and December 2009 in the Pediatric Obesity Clinics (POC) from third level Mexican Hospitals: the HMFG, located in the Federal District (country's capital), and the HRAEB, located in the city of Leon in the state of Guanajauto.
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| ID | Title | Description |
|---|---|---|
| FG000 | Metformin | |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Metformin | |
| BG001 | Placebo | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adiponectin | Change from baseline in Adiponectin after 3 months of treatment. | Posted | Mean | Standard Deviation | µg/mL | baseline and 3 months |
|
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metformin |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epigastric pain | Gastrointestinal disorders | Adverse effect characterized by " burning " epigastric pain |
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During the recruitment phase, 83 children who were diagnosed with obesity and acanthosis nigricans were evaluated. Of these, 45 did not have the insulin concentration values (>15 µU/mL) required to biochemically define Insulin Resistance.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| M.D. Maria L. Evia-Viscarra | Hospital Regional de Alta Especialidad del Bajio | +52 (477) 267-2000 | 1405 | evialola@hotmail.com |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Tablet of 500 mg oral placebo every 12 hours for 3 months. |
|
| baseline and 3 months |
| Body Mass Index | Change from baseline in Body Mass Index after 3 months of treatment. | baseline and 3 months |
| Waist Circumference | Change from baseline in Waist circumference after 3 months of treatment. | baseline and 3 months |
| Study Chair |
| Mexico City |
| Mexico City |
| 06720 |
| Mexico |
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| 22570949 | Derived | Evia-Viscarra ML, Rodea-Montero ER, Apolinar-Jimenez E, Munoz-Noriega N, Garcia-Morales LM, Leanos-Perez C, Figueroa-Barron M, Sanchez-Fierros D, Reyes-Garcia JG. The effects of metformin on inflammatory mediators in obese adolescents with insulin resistance: controlled randomized clinical trial. J Pediatr Endocrinol Metab. 2012;25(1-2):41-9. doi: 10.1515/jpem-2011-0469. |
| Physician Decision |
|
Total of all reporting groups
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | High-sensitivity C-reactive Protein | Change from baseline in High-sensitivity C-reactive protein after 3 months of treatment. | Posted | Mean | Standard Deviation | mg/dL | baseline and 3 months |
|
|
|
| Primary | Interleukin 6 | Change from baseline in Interleukin 6 after 3 months of treatment. | Posted | Mean | Standard Deviation | pg/mL | baseline and 3 months |
|
|
|
| Primary | Tumour Necrosis Factor Alpha | Change from baseline in Tumour necrosis factor alpha after 3 months of treatment. | Posted | Mean | Standard Deviation | pg/mL | baseline and 3 months |
|
|
|
| Secondary | Fasting Plasma Glucose | Change from baseline in Fasting plasma glucose after 3 months of treatment. | Posted | Mean | Standard Deviation | mg/dL | baseline and 3 months |
|
|
|
| Secondary | Fasting Insulin | Change from baseline in Fasting insulin after 3 months of treatment. | Posted | Mean | Standard Deviation | µU/mL | baseline and 3 months |
|
|
|
| Secondary | Body Mass Index | Change from baseline in Body Mass Index after 3 months of treatment. | Posted | Mean | Standard Deviation | kg/m^2 | baseline and 3 months |
|
|
|
| Secondary | Waist Circumference | Change from baseline in Waist circumference after 3 months of treatment. | Posted | Mean | Standard Deviation | cm | baseline and 3 months |
|
|
|
| 2 |
| 15 |
| 0 |
| 15 |
| EG001 | Placebo | 1 | 16 | 0 | 16 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |