Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Lo.Li.Pharma s.r.l | INDUSTRY |
| Azienda Ospedaliera San Paolo | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inositol | Experimental | Administration of Inofolic Combi (Myo-inositol 1100 mg + D-Chiro-inositol 27,6 mg + Folic Acid 400 μg - Lo.Li Pharma S.r.l.) 2 capsules every day for 1 month |
|
| Placebo | Placebo Comparator | Administration of placebo. 2 capsules every day for 1 month |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inofolic Combi | Dietary Supplement | Myo-inositol 1100 mg + D-Chiro-inositol 27,6 mg + Folic Acid 400 μg. 2 capsules every day for 1 month. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Basal Insulin | Evaluation of the efficacy of inositol in reducing basal insulin | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Evaluation of the efficacy of inositol in reducing body weight | 1 month |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mario Mancini | Contact | 00393331009479 | mancinis178@msn.com | |
| Alice Andreassi | Contact | 00393401799869 | aliceandreassi2@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mario Mancini | AO San Paolo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AO San Paolo | Recruiting | Milan | Mi | 20142 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27882052 | Background | Mancini M, Andreassi A, Salvioni M, Pelliccione F, Mantellassi G, Banderali G. Myoinositol and D-Chiro Inositol in Improving Insulin Resistance in Obese Male Children: Preliminary Data. Int J Endocrinol. 2016;2016:8720342. doi: 10.1155/2016/8720342. Epub 2016 Nov 1. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | 2 capsules every day for 1 month |
|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |