Evaluating the Effect of Inositol Supplementation in Overweight Children on Basal Insulin and Body Weight
NCT ID: NCT03920787
Last Updated: 2019-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
23 participants
INTERVENTIONAL
2018-03-10
2020-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Inositol
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
Inofolic Combi
Myo-inositol 1100 mg + D-Chiro-inositol 27,6 mg + Folic Acid 400 μg. 2 capsules every day for 1 month.
Placebo
Administration of placebo. 2 capsules every day for 1 month
Placebo
2 capsules every day for 1 month
Interventions
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Inofolic Combi
Myo-inositol 1100 mg + D-Chiro-inositol 27,6 mg + Folic Acid 400 μg. 2 capsules every day for 1 month.
Placebo
2 capsules every day for 1 month
Eligibility Criteria
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Inclusion Criteria
* overweight or obesity
* basal insulin ≥ 20 uU/ml
Exclusion Criteria
* hypogonadism
* hypothyroidism or hyperthyroidism
* obesity-related genetic diseases
8 Years
18 Years
ALL
No
Sponsors
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Lo.Li.Pharma s.r.l
INDUSTRY
Azienda Ospedaliera San Paolo
OTHER
Alice Andreassi
OTHER
Responsible Party
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Alice Andreassi
Principal Investigator
Principal Investigators
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Mario Mancini
Role: STUDY_DIRECTOR
AO San Paolo
Locations
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AO San Paolo
Milan, Mi, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2017/ST/222
Identifier Type: -
Identifier Source: org_study_id
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