Adipokines in Obese Adolescents With Insulin Resistance
23. dubna 2012 aktualizováno: Maria Lola Evia-Viscarra, Hospital Regional de Alta Especialidad del Bajio
Inflammatory Mediators in Obese Adolescents With Insulin Resistance Following Metformin Treatment: Controlled Randomized Clinical Trial
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).
Přehled studie
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
31
Fáze
- Fáze 4
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Distrito Federal
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México, Distrito Federal, Mexiko, 06720
- Hospital Infantil de Mexico Federico Gomez
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Guanajuato
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León, Guanajuato, Mexiko, 37670
- Hospital Regional de Alta Especialidad del Bajio
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
9 let až 18 let (Dítě, Dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Obesity defined as Body Mass Index (BMI) ≥ percentile 95
- Tanner stage ≥ 2
- Insulin resistance defined as Basal insulin > 15 µU/mL or Homeostasis Model Assessment index (HOMA) > 4.5
- Patients' parents signed written consents when they and their adolescent children agreed to enroll
Exclusion Criteria:
- Glucose intolerance
- Diabetes mellitus (type 1 or 2)
- Anemia (Hb < 10 g/dL)
- Plasma creatinine > 1.4 mg/dL
- Abnormal hepatic function
- Any associated Disease (Pulmonary, Infection, Autoimmune Disease)
- History of lactic acidosis
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Metformin
Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months.
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Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months.
Ostatní jména:
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Komparátor placeba: Placebo
Tablet of 500 mg oral placebo every 12 hours for 3 months.
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Tablet of 500 mg oral placebo every 12 hours for 3 months.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Adiponectin
Časové okno: baseline and 3 months
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Change from baseline in Adiponectin after 3 months of treatment.
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baseline and 3 months
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High-sensitivity C-reactive Protein
Časové okno: baseline and 3 months
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Change from baseline in High-sensitivity C-reactive protein after 3 months of treatment.
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baseline and 3 months
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Interleukin 6
Časové okno: baseline and 3 months
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Change from baseline in Interleukin 6 after 3 months of treatment.
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baseline and 3 months
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Tumour Necrosis Factor Alpha
Časové okno: baseline and 3 months
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Change from baseline in Tumour necrosis factor alpha after 3 months of treatment.
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baseline and 3 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Fasting Plasma Glucose
Časové okno: baseline and 3 months
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Change from baseline in Fasting plasma glucose after 3 months of treatment.
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baseline and 3 months
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Fasting Insulin
Časové okno: baseline and 3 months
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Change from baseline in Fasting insulin after 3 months of treatment.
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baseline and 3 months
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Body Mass Index
Časové okno: baseline and 3 months
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Change from baseline in Body Mass Index after 3 months of treatment.
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baseline and 3 months
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Waist Circumference
Časové okno: baseline and 3 months
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Change from baseline in Waist circumference after 3 months of treatment.
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baseline and 3 months
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Maria L Evia-Viscarra, M.D., Hospital Regional de Alta Especialidad del Bajio
- Studijní židle: Edel R Rodea-Montero, Statistician, Hospital Regional de Alta Especialidad del Bajio
- Studijní židle: Evelia Apolinar-Jiménez, Nutrition, Hospital Regional de Alta Especialidad del Bajio
- Studijní židle: Leticia M García-Morales, M.D., Hospital Infantil de Mexico Federico Gomez
- Studijní židle: Constanza Leaños-Pérez, M.D., Hospital Infantil de Mexico Federico Gomez
- Studijní židle: Mireya Figueroa-Barrón, Chemestry, Hospital Infantil de Mexico Federico Gomez
- Studijní židle: Dolores Sánchez-Fierros, Chemestry, Hospital Infantil de Mexico Federico Gomez
- Studijní židle: Nathalie Muñoz-Noriega, Nutrition, Hospital Regional de Alta Especialidad del Bajio
- Studijní židle: Juan G Reyes-García, M.D., Escuela Superior de Medicina del IPN
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
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Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. ledna 2007
Primární dokončení (Aktuální)
1. prosince 2009
Dokončení studie (Aktuální)
1. března 2010
Termíny zápisu do studia
První předloženo
4. srpna 2011
První předloženo, které splnilo kritéria kontroly kvality
4. srpna 2011
První zveřejněno (Odhad)
5. srpna 2011
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
27. dubna 2012
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
23. dubna 2012
Naposledy ověřeno
1. dubna 2012
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 010-08
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