Insulin Resistance
Conditions
Keywords
inositol, insulin resistance, overweight, children
Brief summary
Inositol in involved in the insulin pathway. In literature it has been demonstrated to improve insulin sensitivity and ovarian function in women affected by PCOS. In a preliminary study conducted on obese children between 7 and 15 years, the investigators have demonstrated that Inositol administration (Myo-inositol 1100 mg + D-Chiro-inositol 27,6 mg + Folic Acid 400 μg) before a Glucose Oral Tolerance Test reduces the increase of insulin levels, particularly in subjects with basal insulin ≥ 15 uU/ml. So the aim of this study is to evaluate the potential therapeutic effect of inositol, as non-pharmacologic agent, in preventing tipe II diabetes in children.
Interventions
DIETARY_SUPPLEMENTInofolic Combi
Myo-inositol 1100 mg + D-Chiro-inositol 27,6 mg + Folic Acid 400 μg. 2 capsules every day for 1 month.
OTHERPlacebo
2 capsules every day for 1 month
Sponsors
Lo.Li.Pharma s.r.l
Azienda Ospedaliera San Paolo
Alice Andreassi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 8-18 years old * overweight or obesity * basal insulin ≥ 20 uU/ml
Exclusion criteria
* pubertal delay * hypogonadism * hypothyroidism or hyperthyroidism * obesity-related genetic diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Basal Insulin | 1 month | Evaluation of the efficacy of inositol in reducing basal insulin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | 1 month | Evaluation of the efficacy of inositol in reducing body weight |
Countries
Italy
Contacts
Primary ContactMario Mancini
Backup ContactAlice Andreassi
Outcome results
None listed