Clinical trial · Interventional
Adipokines in Obese Adolescents With Insulin Resistance
Inflammatory Mediators in Obese Adolescents With Insulin Resistance Following Metformin Treatment: Controlled Randomized Clinical Trial
NCT01410604CI-TRIAL-00006803completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Obesity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Metformin
- description
- Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months.
- interventionNames
- Drug: Metformin
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Tablet of 500 mg oral placebo every 12 hours for 3 months.
- interventionNames
- Drug: Placebo
Primary outcomes (4)
- measure
- Adiponectin
- timeFrame
- baseline and 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 9 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (38)
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- BACKGROUNDWilfley 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. PMID 17845100
- BACKGROUNDZeller M, Kirk S, Claytor R, Khoury P, Grieme J, Santangelo M, Daniels S. Predictors of attrition from a pediatric weight management program. J Pediatr. 2004 Apr;144(4):466-70. doi: 10.1016/j.jpeds.2003.12.031. PMID 15069394
- BACKGROUNDTen S, Maclaren N. Insulin resistance syndrome in children. J Clin Endocrinol Metab. 2004 Jun;89(6):2526-39. doi: 10.1210/jc.2004-0276. PMID 15181020
- BACKGROUNDChiarelli F, Marcovecchio ML. Insulin resistance and obesity in childhood. Eur J Endocrinol. 2008 Dec;159 Suppl 1:S67-74. doi: 10.1530/EJE-08-0245. Epub 2008 Sep 19. PMID 18805916
- BACKGROUNDCruz ML, Weigensberg MJ, Huang TT, Ball G, Shaibi GQ, Goran MI. The metabolic syndrome in overweight Hispanic youth and the role of insulin sensitivity. J Clin Endocrinol Metab. 2004 Jan;89(1):108-13. doi: 10.1210/jc.2003-031188. PMID 14715836
- BACKGROUNDVisser M, Bouter LM, McQuillan GM, Wener MH, Harris TB. Low-grade systemic inflammation in overweight children. Pediatrics. 2001 Jan;107(1):E13. doi: 10.1542/peds.107.1.e13. PMID 11134477
- BACKGROUNDFreedman DS, Mei Z, Srinivasan SR, Berenson GS, Dietz WH. Cardiovascular risk factors and excess adiposity among overweight children and adolescents: the Bogalusa Heart Study. J Pediatr. 2007 Jan;150(1):12-17.e2. doi: 10.1016/j.jpeds.2006.08.042.