Adipokines in Obese Adolescents With Insulin Resistance
23 april 2012 uppdaterad av: 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).
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
31
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Distrito Federal
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México, Distrito Federal, Mexiko, 06720
- Hospital Infantil de México Federico Gómez
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Guanajuato
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León, Guanajuato, Mexiko, 37670
- Hospital Regional de Alta Especialidad del Bajio
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
9 år till 18 år (Barn, Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
Andra namn:
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Placebo-jämförare: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Adiponectin
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Fasting Plasma Glucose
Tidsram: 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
Tidsram: 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
Tidsram: baseline and 3 months
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Change from baseline in Body Mass Index after 3 months of treatment.
|
baseline and 3 months
|
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Waist Circumference
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Maria L Evia-Viscarra, M.D., Hospital Regional de Alta Especialidad del Bajio
- Studiestol: Edel R Rodea-Montero, Statistician, Hospital Regional de Alta Especialidad del Bajio
- Studiestol: Evelia Apolinar-Jiménez, Nutrition, Hospital Regional de Alta Especialidad del Bajio
- Studiestol: Leticia M García-Morales, M.D., Hospital Infantil de México Federico Gómez
- Studiestol: Constanza Leaños-Pérez, M.D., Hospital Infantil de México Federico Gómez
- Studiestol: Mireya Figueroa-Barrón, Chemestry, Hospital Infantil de México Federico Gómez
- Studiestol: Dolores Sánchez-Fierros, Chemestry, Hospital Infantil de México Federico Gómez
- Studiestol: Nathalie Muñoz-Noriega, Nutrition, Hospital Regional de Alta Especialidad del Bajio
- Studiestol: Juan G Reyes-García, M.D., Escuela Superior de Medicina del IPN
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2007
Primärt slutförande (Faktisk)
1 december 2009
Avslutad studie (Faktisk)
1 mars 2010
Studieregistreringsdatum
Först inskickad
4 augusti 2011
Först inskickad som uppfyllde QC-kriterierna
4 augusti 2011
Första postat (Uppskatta)
5 augusti 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
27 april 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 april 2012
Senast verifierad
1 april 2012
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 010-08
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