Evaluating the Effect of Inositol Supplementation in Overweight Children on Basal Insulin and Body Weight
Effects of Inositol Supplementation in Children With Excessive Body Weight and Insulin Resistance
1 other identifier
interventional
23
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 10, 2018
CompletedFirst Submitted
Initial submission to the registry
April 16, 2019
CompletedFirst Posted
Study publicly available on registry
April 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedApril 22, 2019
April 1, 2019
2 years
April 16, 2019
April 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Basal Insulin
Evaluation of the efficacy of inositol in reducing basal insulin
1 month
Secondary Outcomes (1)
Body weight
1 month
Study Arms (2)
Inositol
EXPERIMENTALAdministration 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 COMPARATORAdministration of placebo. 2 capsules every day for 1 month
Interventions
Myo-inositol 1100 mg + D-Chiro-inositol 27,6 mg + Folic Acid 400 μg. 2 capsules every day for 1 month.
Eligibility Criteria
You may qualify if:
- years old
- overweight or obesity
- basal insulin ≥ 20 uU/ml
You may not qualify if:
- pubertal delay
- hypogonadism
- hypothyroidism or hyperthyroidism
- obesity-related genetic diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alice Andreassilead
- Lo.Li.Pharma s.r.lcollaborator
- Azienda Ospedaliera San Paolocollaborator
Study Sites (1)
AO San Paolo
Milan, Mi, 20142, Italy
Related 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. doi: 10.1155/2016/8720342. Epub 2016 Nov 1.
PMID: 27882052BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mario Mancini
AO San Paolo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 16, 2019
First Posted
April 19, 2019
Study Start
March 10, 2018
Primary Completion
March 1, 2020
Study Completion
April 1, 2020
Last Updated
April 22, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share