Gestational DiabetesPhase 4NCT01511835
Efficacy of Myo-inositol in Preventing Gestational Diabetes in High-risk Pregnant Women
A Phase 4 study testing inositol + folic acid and Folic Acid in people with Gestational Diabetes, run by AGUNCO Obstetrics and Gynecology Centre at 1 site in Italy.
Trial summary
The aim of this study is to evaluate the efficacy of myo-inositol in preventing gestational diabetes in high risk pregnant women. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- inositol + folic acid and Folic Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Start not givento not given
- Phase
- Phase 4
- 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 20 to 45 years
- Women only
- Adult
Who may be able to join
- 60 women in their first trimester of pregnancy affected by one or more of the following risk factors:
- Glycemia levels > 92 mg/dl
- BMI > 30
- At least a parent or a brother (or sister)affected by diabetes
- Pre-existing pregnancy with gestational diabetes
Who cannot join
- Pregnant women affected by pregestational diabetes
- Twin pregnancy
- Patients affected by pre-existing diseases in pregnancy (diabetes excluded)
- Patients affected by chronic disorders
Trial locations and contacts
1 site in 1 country.
Vittorio Unfer contact
Gianfranco Carlomagno contact
Italy1 site, 1 recruiting
- Recruiting
AGUNCO
Rome, 00155
Gianfranco Carlomagno, gianfranco.carlomagno@agunco.it
Vittorio Unfer
About this study
The aim of this study is to evaluate the efficacy of myo-inositol in preventing gestational diabetes in high risk pregnant women.
- Conditions
- Gestational Diabetes
- Being tested
- inositol + folic acid, Folic Acid
- Keywords
- diabetes, pregnancy, myo-inositol
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inositol + folic acidDietary supplement
2000 mg of inositol+200mcg of folic acid; 2 per diem
inositol + folic acidDietary supplement
600 mg of inositol + 200mcg of folic acid; 2 cp per diem
Folic AcidDrug
Folic Acid 400mcg; 1 cp/die
| Study group | Role | What they receive |
|---|---|---|
| Myo-inositol powder | Experimental | Not described Receives: Dietary Supplement: inositol + folic acid |
| Myo-inositol soft gel capsules | Experimental | Not described Receives: Dietary Supplement: inositol + folic acid |
| Folic acid | Placebo comparator | Not described Receives: Drug: Folic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
OGTT
The diagnostic 75g oral glucose tolerance test (OGTT) is performed between 24 and 28 weeks of gestation.
Secondary outcomes (5)
Number of pregnant women with gestational diabetes
Number of pregnant women requiring insulin treatment
Weight gain at the end of pregnancy
Number of newborn infants whose weight is more than 4000 g
Number of newborn infants requiring Neonatal Intensive Care (NIC)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies 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 4
Sponsor and investigators
- Lead sponsor
- AGUNCO Obstetrics and Gynecology Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511835
- Sponsor's protocol ID
- MyoIN_diab
- Status last verified
- Jan 2012
- First submitted
- 16 Nov 2011
- Last updated
- 19 Jan 2012
- Results posted
- No
Publications
Papaleo E, Unfer V, Baillargeon JP, Chiu TT. Contribution of myo-inositol to reproduction. Eur J Obstet Gynecol Reprod Biol. 2009 Dec;147(2):120-3. doi: 10.1016/j.ejogrb.2009.09.008. Epub 2009 Oct 2.
PubMed 19800728Corrado F, D'Anna R, Di Vieste G, Giordano D, Pintaudi B, Santamaria A, Di Benedetto A. The effect of myoinositol supplementation on insulin resistance in patients with gestational diabetes. Diabet Med. 2011 Aug;28(8):972-5. doi: 10.1111/j.1464-5491.2011.03284.x.
PubMed 21414183Motuhifonua SK, Lin L, Alsweiler J, Crawford TJ, Crowther CA. Antenatal dietary supplementation with myo-inositol for preventing gestational diabetes. Cochrane Database Syst Rev. 2023 Feb 15;2(2):CD011507. doi: 10.1002/14651858.CD011507.pub3.
PubMed 36790138
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Myo-inositol in Preventing Gestational Diabetes in High-risk Pregnant Women
- ClinicalTrials.gov ID
- NCT01511835
- Acronym / sponsor ID
- MyoIN_diab
- Conditions
- Gestational Diabetes
- Keywords
- diabetes, pregnancy, myo-inositol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- AGUNCO Obstetrics and Gynecology CentreUniversity, hospital or other
- First posted
- 19 Jan 2012 (estimated)
- 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.
The aim of this study is to evaluate the efficacy of myo-inositol in preventing gestational diabetes in high risk pregnant women.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Myo-inositol powder | Experimental | Dietary Supplement: inositol + folic acid |
| Myo-inositol soft gel capsules | Experimental | Dietary Supplement: inositol + folic acid |
| Folic acid | Placebo comparator | Drug: Folic Acid |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 60 women in their first trimester of pregnancy affected by one or more of the following risk factors:
- Glycemia levels > 92 mg/dl
- BMI > 30
- At least a parent or a brother (or sister)affected by diabetes
- Pre-existing pregnancy with gestational diabetes
Key exclusion criteria (4 listed)
- Pregnant women affected by pregestational diabetes
- Twin pregnancy
- Patients affected by pre-existing diseases in pregnancy (diabetes excluded)
- Patients affected by chronic disorders
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 |
|---|---|---|
| inositol + folic acid2000 mg of inositol+200mcg of folic acid; 2 per diem | Dietary supplement | Myo-inositol powder |
| inositol + folic acid600 mg of inositol + 200mcg of folic acid; 2 cp per diem | Dietary supplement | Myo-inositol soft gel capsules |
| Folic AcidFolic Acid 400mcg; 1 cp/die | Drug | Folic acid |
Primary outcome
OGTT
The diagnostic 75g oral glucose tolerance test (OGTT) is performed between 24 and 28 weeks of gestation.
5 secondary outcomes
Number of pregnant women with gestational diabetes
Number of pregnant women requiring insulin treatment
Weight gain at the end of pregnancy
Number of newborn infants whose weight is more than 4000 g
Number of newborn infants requiring Neonatal Intensive Care (NIC)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2012.
- Background: PubMed 19800728Papaleo E, Unfer V, Baillargeon JP, Chiu TT. Contribution of myo-inositol to reproduction. Eur J Obstet Gynecol Reprod Biol. 2009 Dec;147(2):120-3. doi: 10.1016/j.ejogrb.2009.09.008. Epub 2009 Oct 2.
- Background: PubMed 21414183Corrado F, D'Anna R, Di Vieste G, Giordano D, Pintaudi B, Santamaria A, Di Benedetto A. The effect of myoinositol supplementation on insulin resistance in patients with gestational diabetes. Diabet Med. 2011 Aug;28(8):972-5. doi: 10.1111/j.1464-5491.2011.03284.x.
- Derived from this study: PubMed 36790138Motuhifonua SK, Lin L, Alsweiler J, Crawford TJ, Crowther CA. Antenatal dietary supplementation with myo-inositol for preventing gestational diabetes. Cochrane Database Syst Rev. 2023 Feb 15;2(2):CD011507. doi: 10.1002/14651858.CD011507.pub3.
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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.
Vittorio Unfer contact
Gianfranco Carlomagno contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing inositol + folic acid and Folic Acid in people with Gestational Diabetes, run by AGUNCO Obstetrics and Gynecology Centre 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 5 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 19 Jan 2012. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Vittorio Unfer (vunfer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OGTT. 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 NCT01511835, which also lists 3 linked publications.
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 19 Jan 2012.