Evaluating the Effect of Inositol Supplementation in Overweight Children on Basal Insulin and Body Weight

Insulin Resistance Clinical Trial

Official title:

Effects of Inositol Supplementation in Children With Excessive Body Weight and Insulin Resistance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03920787
• Other study ID #: 2017/ST/222
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2018
• Est. completion date: April 2020

Study information

• Verified date: April 2019
• Source: Azienda Ospedaliera San Paolo
• Contact: Mario Mancini
• Phone: 00393331009479
• Email: mancinis178[@]msn.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 23
• Est. completion date: April 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Insulin Resistance

Intervention

Dietary Supplement:
• Inofolic Combi
Myo-inositol 1100 mg + D-Chiro-inositol 27,6 mg + Folic Acid 400 µg. 2 capsules every day for 1 month.

Other:
• Placebo
2 capsules every day for 1 month

Locations

Country	Name	City	State
Italy	AO San Paolo	Milan	Mi

Sponsors (3)

Lead Sponsor	Collaborator
Alice Andreassi	Azienda Ospedaliera San Paolo, Lo.Li.Pharma s.r.l

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. Epub 2016 Nov 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Basal Insulin	Evaluation of the efficacy of inositol in reducing basal insulin	1 month
Secondary	Body weight	Evaluation of the efficacy of inositol in reducing body weight	1 month