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NCT05701813
The Study Aims to Investigate the Effects of Oral Inositols on Insulin-resistance in Children With Obesity.
Conditions: Obesity, Prediabetic State, Dyslipidemias, Insulin Resistance
Sex: All
Ages: 8 Years – 12 Years
Phase: NA
Enrollment: 56
Sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Summary
The study aims to investigate the effects of oral inositols on insulin-resistance and metabolic variables (triglycerides, total cholesterol, HDL cholesterol) in children aged 8-12 years with obesity and insulin-resistance.
Eligibility Criteria
Inclusion Criteria:Age under 12 and over 8 yearsPresence of obesity defined by BMI > 95th percentile of BMI based on the growth curves of the Italian Society of Pediatric Endocrinology and Diabetology (Cacciari curves)Presence of HOMA-IR value (insulin x glycaemia/22.5:
marker of insulin resistance) > 75th percentile of a reference pediatric population from VeronaExclusion Criteria:Diabetes mellitusCurrent chronic disease with systemic inflammationUse of drugs acting on insulin sensitivity (e.g.
steroids)Use of food or vitamin supplements up to one month before blood samplingPuberty in progress
Source: ClinicalTrials.gov (NCT05701813). StuddyBuddy aggregates publicly available trial information.
