Effects of Inositols on Insulin Resistance in Children With Obesity (ONIRICO Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 56
- Primary Endpoint
- Efficacy on insulin-resistance, measured with the HOMA-IR index
Study Overview
Brief 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.
Detailed Description
Insulin-resistance is a condition, frequently related to obesity, that leads to cardio-metabolic complications in both children and adults, such as type 2 diabetes, hypertension, dyslipidemia and NAFLD. The best method to lower insulin-resistance is losing weight and doing physical activity, however changing lifestyle statistically reduces excess weight mildly. Also the genetic predisposition for a positive caloric balance, the difficulty in doing physical activity regularly and the metabolic and neuroendocrine responses aimed at preserving energy make it difficult to lose weight and/or improve one's insulin sensitivity. Infact, 80% of children chronicize their obesity into adulthood. For this reason, treatment should be based on both lifestyle changes and complementary approaches. Nutraceuticals can regulate physiological functions and are ideal candidates for children, since they are highly tolerated.
Myo-inositol and D-chiro-inositol are stereoisomers of sugar which, in combination with diacylglycerol (DAG), produce phosphatidylinositol (PI), precursor in the signalling of insulin and other hormones (growth factors and FSH). The insulin receptors leads to PI phosphorylation in PIP3, which activates kinases, such as Akt, that cause nuclear (cell proliferation) and cytoplasmatic (activation of glycogen synthetase) effetcs. It also activates phospholipase C, which hydrolyses PIP2 into DAG and IP3. IP3 leads to calcium liberation and moves GLUT4 to the surface of the cell membrane.
Inositols are also precursors of inositol-6 phosphate, which is important to promote adipocytes differentiation and fat oxidation.
Level A evidence shows that dietary supplements with one or both inositols used in women with PCOS to improve ovarian function, are highly effective also on insulin-sensitivity.
The aim of this study is to compare the efficacy of inositols versus placebo on insulin-resistance, measured with the HOMA-IR index, in a sample of children with obesity. As a secondary outcome, the study aims to enlight potential improvements in triglycerides, total cholesterol and HDL cholesterol.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Randomisation is performed by the nutraceutical supplier. Neither the participant, nor the investigator, nor the care provider, nor the outcome analyzer knows which arm the patient is assigned to.
Eligibility Criteria
- Ages
- 8 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age under 12 and over 8 years
- •Presence 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 Verona
Exclusion Criteria
- •Diabetes mellitus
- •Current chronic disease with systemic inflammation
- •Use of drugs acting on insulin sensitivity (e.g. steroids)
- •Use of food or vitamin supplements up to one month before blood sampling
- •Puberty in progress
Arms & Interventions
PLACEBO
Cellulose 4.3 grams once a day for 90 days.
Intervention: CELLULOSE (Dietary Supplement)
INOSITOLS
4000 mg of myo-inositol and 300 mg of D-chiro-inositol. Once a day for 90 days.
Intervention: INOSITOLS (Dietary Supplement)
Outcomes
Primary Outcomes
Efficacy on insulin-resistance, measured with the HOMA-IR index
Time Frame: 90 days
Difference in HOMA-IR index change across arms
Secondary Outcomes
- Improvements in triglycerides, total cholesterol and HDL cholesterol.(90 days)
Investigators
Anita Morandi
Prof.ssa
Azienda Ospedaliera Universitaria Integrata Verona