Adipokines in Obese Adolescents With Insulin Resistance
23. April 2012 aktualisiert von: 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).
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
31
Phase
- Phase 4
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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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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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
9 Jahre bis 18 Jahre (Kind, Erwachsene)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
Andere Namen:
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Placebo-Komparator: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Adiponectin
Zeitfenster: baseline and 3 months
|
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
Zeitfenster: baseline and 3 months
|
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
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Fasting Plasma Glucose
Zeitfenster: baseline and 3 months
|
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
Zeitfenster: 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
Zeitfenster: baseline and 3 months
|
Change from baseline in Body Mass Index after 3 months of treatment.
|
baseline and 3 months
|
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Waist Circumference
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Ermittler
- Hauptermittler: Maria L Evia-Viscarra, M.D., Hospital Regional de Alta Especialidad del Bajio
- Studienstuhl: Edel R Rodea-Montero, Statistician, Hospital Regional de Alta Especialidad del Bajio
- Studienstuhl: Evelia Apolinar-Jiménez, Nutrition, Hospital Regional de Alta Especialidad del Bajio
- Studienstuhl: Leticia M García-Morales, M.D., Hospital Infantil de Mexico Federico Gomez
- Studienstuhl: Constanza Leaños-Pérez, M.D., Hospital Infantil de Mexico Federico Gomez
- Studienstuhl: Mireya Figueroa-Barrón, Chemestry, Hospital Infantil de Mexico Federico Gomez
- Studienstuhl: Dolores Sánchez-Fierros, Chemestry, Hospital Infantil de Mexico Federico Gomez
- Studienstuhl: Nathalie Muñoz-Noriega, Nutrition, Hospital Regional de Alta Especialidad del Bajio
- Studienstuhl: Juan G Reyes-García, M.D., Escuela Superior de Medicina del IPN
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
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- SEARCH for Diabetes in Youth Study Group, Liese AD, D'Agostino RB Jr, Hamman RF, Kilgo PD, Lawrence JM, Liu LL, Loots B, Linder B, Marcovina S, Rodriguez B, Standiford D, Williams DE. The burden of diabetes mellitus among US youth: prevalence estimates from the SEARCH for Diabetes in Youth Study. Pediatrics. 2006 Oct;118(4):1510-8. doi: 10.1542/peds.2006-0690.
- Kay JP, Alemzadeh R, Langley G, D'Angelo L, Smith P, Holshouser S. Beneficial effects of metformin in normoglycemic morbidly obese adolescents. Metabolism. 2001 Dec;50(12):1457-61. doi: 10.1053/meta.2001.28078.
- Love-Osborne K, Sheeder J, Zeitler P. Addition of metformin to a lifestyle modification program in adolescents with insulin resistance. J Pediatr. 2008 Jun;152(6):817-22. doi: 10.1016/j.jpeds.2008.01.018. Epub 2008 Mar 19.
- Srinivasan S, Ambler GR, Baur LA, Garnett SP, Tepsa M, Yap F, Ward GM, Cowell CT. Randomized, controlled trial of metformin for obesity and insulin resistance in children and adolescents: improvement in body composition and fasting insulin. J Clin Endocrinol Metab. 2006 Jun;91(6):2074-80. doi: 10.1210/jc.2006-0241. Epub 2006 Apr 4.
- Trayhurn P, Beattie JH. Physiological role of adipose tissue: white adipose tissue as an endocrine and secretory organ. Proc Nutr Soc. 2001 Aug;60(3):329-39. doi: 10.1079/pns200194.
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- Weiss R, Dufour S, Groszmann A, Petersen K, Dziura J, Taksali SE, Shulman G, Caprio S. Low adiponectin levels in adolescent obesity: a marker of increased intramyocellular lipid accumulation. J Clin Endocrinol Metab. 2003 May;88(5):2014-8. doi: 10.1210/jc.2002-021711.
- Moon YS, Kim DH, Song DK. Serum tumor necrosis factor-alpha levels and components of the metabolic syndrome in obese adolescents. Metabolism. 2004 Jul;53(7):863-7. doi: 10.1016/j.metabol.2004.02.007.
- Herder C, Schneitler S, Rathmann W, Haastert B, Schneitler H, Winkler H, Bredahl R, Hahnloser E, Martin S. Low-grade inflammation, obesity, and insulin resistance in adolescents. J Clin Endocrinol Metab. 2007 Dec;92(12):4569-74. doi: 10.1210/jc.2007-0955. Epub 2007 Oct 2.
- Cartier A, Lemieux I, Almeras N, Tremblay A, Bergeron J, Despres JP. Visceral obesity and plasma glucose-insulin homeostasis: contributions of interleukin-6 and tumor necrosis factor-alpha in men. J Clin Endocrinol Metab. 2008 May;93(5):1931-8. doi: 10.1210/jc.2007-2191. Epub 2008 Mar 4.
- Ford ES, Galuska DA, Gillespie C, Will JC, Giles WH, Dietz WH. C-reactive protein and body mass index in children: findings from the Third National Health and Nutrition Examination Survey, 1988-1994. J Pediatr. 2001 Apr;138(4):486-92. doi: 10.1067/mpd.2001.112898.
- Hiura M, Kikuchi T, Nagasaki K, Uchiyama M. Elevation of serum C-reactive protein levels is associated with obesity in boys. Hypertens Res. 2003 Jul;26(7):541-6. doi: 10.1291/hypres.26.541.
- Freedman DS, Sherry B. The validity of BMI as an indicator of body fatness and risk among children. Pediatrics. 2009 Sep;124 Suppl 1:S23-34. doi: 10.1542/peds.2008-3586E.
- Cole TJ, Bellizzi MC, Flegal KM, Dietz WH. Establishing a standard definition for child overweight and obesity worldwide: international survey. BMJ. 2000 May 6;320(7244):1240-3. doi: 10.1136/bmj.320.7244.1240.
- Reaven GM, Chen YD, Hollenbeck CB, Sheu WH, Ostrega D, Polonsky KS. Plasma insulin, C-peptide, and proinsulin concentrations in obese and nonobese individuals with varying degrees of glucose tolerance. J Clin Endocrinol Metab. 1993 Jan;76(1):44-8. doi: 10.1210/jcem.76.1.8421101.
- Keskin M, Kurtoglu S, Kendirci M, Atabek ME, Yazici C. Homeostasis model assessment is more reliable than the fasting glucose/insulin ratio and quantitative insulin sensitivity check index for assessing insulin resistance among obese children and adolescents. Pediatrics. 2005 Apr;115(4):e500-3. doi: 10.1542/peds.2004-1921. Epub 2005 Mar 1.
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Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Januar 2007
Primärer Abschluss (Tatsächlich)
1. Dezember 2009
Studienabschluss (Tatsächlich)
1. März 2010
Studienanmeldedaten
Zuerst eingereicht
4. August 2011
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
4. August 2011
Zuerst gepostet (Schätzen)
5. August 2011
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
27. April 2012
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
23. April 2012
Zuletzt verifiziert
1. April 2012
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 010-08
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