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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03920787
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : April 22, 2019
Sponsor:
Collaborators:
Lo.Li.Pharma s.r.l
Azienda Ospedaliera San Paolo
Information provided by (Responsible Party):
Alice Andreassi, Azienda Ospedaliera San Paolo

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.


Condition or disease Intervention/treatment Phase
Insulin Resistance Dietary Supplement: Inofolic Combi Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Inositol Supplementation in Children With Excessive Body Weight and Insulin Resistance
Actual Study Start Date : March 10, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
Drug Information available for: Inositol

Arm Intervention/treatment
Experimental: 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
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.

Placebo Comparator: Placebo
Administration of placebo. 2 capsules every day for 1 month
Other: Placebo
2 capsules every day for 1 month




Primary Outcome Measures :
  1. Basal Insulin [ Time Frame: 1 month ]
    Evaluation of the efficacy of inositol in reducing basal insulin


Secondary Outcome Measures :
  1. Body weight [ Time Frame: 1 month ]
    Evaluation of the efficacy of inositol in reducing body weight



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920787


Contacts
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Contact: Mario Mancini 00393331009479 mancinis178@msn.com
Contact: Alice Andreassi 00393401799869 aliceandreassi2@gmail.com

Locations
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Italy
AO San Paolo Recruiting
Milan, Mi, Italy, 20142
Contact: Mario Mancini    00393331009479    mancinis178@msn.com   
Contact: Alice Andreassi    00393401799860    aliceandreassi2@gmail.com   
Sponsors and Collaborators
Alice Andreassi
Lo.Li.Pharma s.r.l
Azienda Ospedaliera San Paolo
Investigators
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Study Director: Mario Mancini AO San Paolo
Publications:
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Responsible Party: Alice Andreassi, Principal Investigator, Azienda Ospedaliera San Paolo
ClinicalTrials.gov Identifier: NCT03920787    
Other Study ID Numbers: 2017/ST/222
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alice Andreassi, Azienda Ospedaliera San Paolo:
inositol
insulin resistance
overweight
children
Additional relevant MeSH terms:
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Insulin Resistance
Body Weight
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases