Insulin ResistanceNCT03920787
Evaluating the Effect of Inositol Supplementation in Overweight Children on Basal Insulin and Body Weight
A study testing Inofolic Combi in people with Insulin Resistance, run by Alice Andreassi at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Inofolic Combi
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteItaly
- Study dates
- 10 Mar 2018to Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 8-18 years old
- overweight or obesity
- basal insulin ≥ 20 uU/ml
Who cannot join
- pubertal delay
- hypogonadism
- hypothyroidism or hyperthyroidism
- obesity-related genetic diseases
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AO San Paolo
Milan, Mi, 20142
Mario Mancini, 00393331009479, mancinis178@msn.com
Alice Andreassi, 00393401799860, aliceandreassi2@gmail.com
About this study
Official title: Effects of Inositol Supplementation in Children With Excessive Body Weight and Insulin Resistance
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.
- Conditions
- Insulin Resistance
- Being tested
- Inofolic Combi, Placebo
- Keywords
- inositol, insulin resistance, overweight, children
- Medical subject headings
- Insulin Resistance, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inofolic CombiDietary supplement
Myo-inositol 1100 mg + D-Chiro-inositol 27,6 mg + Folic Acid 400 μg. 2 capsules every day for 1 month.
PlaceboOther
2 capsules every day for 1 month
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Inofolic Combi |
| Placebo | Placebo comparator | Administration of placebo. 2 capsules every day for 1 month Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Basal Insulin
Evaluation of the efficacy of inositol in reducing basal insulin
Measured: 1 month
Secondary outcomes (1)
Body weight
Evaluation of the efficacy of inositol in reducing body weight
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start10 Mar 2018
- Primary completionMar 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alice Andreassi
- Sponsor type
- University, hospital or other
- Collaborators
- Lo.Li.Pharma s.r.l, Azienda Ospedaliera San Paolo
- Responsible party
- Sponsor-investigator, Alice Andreassi, Azienda Ospedaliera San Paolo
- Investigators
- Mario Mancini, Study director, AO San Paolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920787
- Sponsor's protocol ID
- 2017/ST/222
- Status last verified
- Apr 2019
- First submitted
- 16 Apr 2019
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27882052
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inositol Supplementation in Children With Excessive Body Weight and Insulin Resistance
- ClinicalTrials.gov ID
- NCT03920787
- Acronym / sponsor ID
- 2017/ST/222
- Conditions
- Insulin Resistance
- Keywords
- inositol, insulin resistance, overweight, children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Alice AndreassiUniversity, hospital or other
- Collaborators
- Lo.Li.Pharma s.r.l, Azienda Ospedaliera San Paolo
- Study start
- 10 Mar 2018 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 19 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inositol | Experimental | Dietary Supplement: Inofolic CombiAdministration 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 | Other: PlaceboAdministration of placebo. 2 capsules every day for 1 month |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 8-18 years old
- overweight or obesity
- basal insulin ≥ 20 uU/ml
Key exclusion criteria (4 listed)
- pubertal delay
- hypogonadism
- hypothyroidism or hyperthyroidism
- obesity-related genetic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inofolic CombiMyo-inositol 1100 mg + D-Chiro-inositol 27,6 mg + Folic Acid 400 μg. 2 capsules every day for 1 month. | Dietary supplement | Inositol |
| Placebo2 capsules every day for 1 month | Other | Placebo |
Primary outcome
Basal Insulin
Time frame: 1 month
Evaluation of the efficacy of inositol in reducing basal insulin
1 secondary outcome
Body weight
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
- Background: PubMed 27882052Mancini 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario Mancini study director
AO San Paolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inofolic Combi in people with Insulin Resistance, run by Alice Andreassi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mario Mancini (00393331009479, mancinis178@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Basal Insulin (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03920787, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2019.