Phase 4 N=31 Randomized Quadruple-blind Treatment

Adipokines in Obese Adolescents With Insulin Resistance

Obesity

Bottom Line

View on ClinicalTrials.gov: NCT01410604 ↗

Enrolled (actual)

Serious AEs

9.7%

Results posted

Apr 2012

Primary outcome: Primary: Adiponectin — -0.71; -7.52 µg/mL

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Metformin (Drug); Placebo (Drug)
Age: Pediatric, Adult · 9+ yrs
Sex: All
Sponsor: Hospital Regional de Alta Especialidad del Bajio
Primary completion: Dec 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Adiponectin	-0.71; -7.52	—
PRIMARY High-sensitivity C-reactive Protein	-1.26; -1.35	—
PRIMARY Interleukin 6	-34.09; 16.42	—
PRIMARY Tumour Necrosis Factor Alpha	-34.08; -4.01	—
SECONDARY Fasting Plasma Glucose	-1.08; 1.71	—
SECONDARY Fasting Insulin	-3.97; 11.03	—
SECONDARY Body Mass Index	-0.74; -0.71	—
SECONDARY Waist Circumference	-0.57; -3.29	—

Summary

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).

Eligibility Criteria

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 1.4 mg/dL
Abnormal hepatic function
Any associated Disease (Pulmonary, Infection, Autoimmune Disease)
History of lactic acidosis

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Data sourced from ClinicalTrials.gov (NCT01410604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.