Gestational DiabetesNCT01047982
Myo-inositol in Obese Pregnant Women
A study testing myo-inositol and folic acid 400 mcg in people with Gestational Diabetes, run by University of Messina at 1 site in Italy.
Trial summary
Myo-Inositol is classified as a member of the vitamin B complex. It is a constituent of living cells and is widespread in many food. It is involved in a number of biological processes, including insulin signal transduction, resulting in modulating insulin sensitivity. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- myo-inositol and folic acid 400 mcg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2010to Dec 2013
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Obese pregnant women: BMI > 30 Kg/cm2
- first trimester fast glycaemia < 126 mg/dl
- single pregnancy
Who cannot join
- Pregnant women with BMI < 30 Kg/cm2
- first trimester fast glycaemia > 126 mg/dl
- previous gestational diabetes
- twin pregnancy
- pregestational diabetes
- associated therapies with corticosteroids
Trial locations and contacts
1 site in 1 country.
Italy1 site
Obstetrics and Gynecology Unit, University of Messina and Obstetrics and Gynecology Unit of Modena University
Messina and Modena
About this study
Official title: Myo-inositol May Prevent Gestational Diabetes in Obese Women
Myo-Inositol is classified as a member of the vitamin B complex. It is a constituent of living cells and is widespread in many food. It is involved in a number of biological processes, including insulin signal transduction, resulting in modulating insulin sensitivity. This is a prospective, randomized, double center, placebo-controlled study. Two hundred and twenty obese pregnant women will be included in the trial and, after an informed consent, will assume randomly 2 g of myo-inositol twice a day or placebo from 12-13th weeks gestation until delivery. Then,they will perform an Oral Glucose Tolerance Test (OGTT) at 24-28th weeks gestation. Records about delivery (gestational age, neonatal weight...) will be registered.
- Conditions
- Gestational Diabetes
- Being tested
- myo-inositol, folic acid 400 mcg
- Keywords
- gestational diabetes, macrosomia, hypertension in pregnancy, HOMA-IR, obesity
- Medical subject headings
- Diabetes, Gestational, Hypertension, Pregnancy-Induced, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myo-inositolDietary supplement
myo-inositol 2 grams plus folic acid 400 mcg twice a day
folic acid 400 mcgOther
2 pills a day
| Study group | Role | What they receive |
|---|---|---|
| myo-inositol | Active comparator | Not described Receives: Dietary Supplement: myo-inositol |
| placebo | Placebo comparator | acid folic 400 mcg twice per day Receives: Other: folic acid 400 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of gestational diabetes cases diagnosed with OGTT
Measured: 24-28th weeks gestation
difference in HOMA values
Measured: from first trimester to OGTT
Secondary outcomes (1)
incidence of pregnancy complications: hypertension, preterm delivery. macrosomia, shoulder dystocia, etc.
Measured: at delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Messina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosario D'anna, University of Messina
- Investigators
- Rosario D'Anna, professor, Principal investigator, University of Messina, ITALY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047982
- Sponsor's protocol ID
- INOGDM-2010
- Status last verified
- Feb 2014
- First submitted
- 12 Jan 2010
- Last updated
- 28 Feb 2014
- Results posted
- No
Publications
Motuhifonua 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 36790138D'Anna R, Di Benedetto A, Scilipoti A, Santamaria A, Interdonato ML, Petrella E, Neri I, Pintaudi B, Corrado F, Facchinetti F. Myo-inositol Supplementation for Prevention of Gestational Diabetes in Obese Pregnant Women: A Randomized Controlled Trial. Obstet Gynecol. 2015 Aug;126(2):310-315. doi: 10.1097/AOG.0000000000000958.
PubMed 26241420
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myo-inositol May Prevent Gestational Diabetes in Obese Women
- ClinicalTrials.gov ID
- NCT01047982
- Acronym / sponsor ID
- INOGDM-2010
- Conditions
- Gestational Diabetes
- Keywords
- gestational diabetes, macrosomia, hypertension in pregnancy, HOMA-IR, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University of MessinaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 13 Jan 2010 (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.
Myo-Inositol is classified as a member of the vitamin B complex. It is a constituent of living cells and is widespread in many food. It is involved in a number of biological processes, including insulin signal transduction, resulting in modulating insulin sensitivity. This is a prospective, randomized, double center, placebo-controlled study. Two hundred and twenty obese pregnant women will be included in the trial and, after an informed consent, will assume randomly 2 g of myo-inositol twice a day or placebo from 12-13th weeks gestation until delivery. Then,they will perform an Oral Glucose Tolerance Test (OGTT) at 24-28th weeks gestation. Records about delivery (gestational age, neonatal weight...) will be registered.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| myo-inositol | Active comparator | Dietary Supplement: myo-inositol |
| placebo | Placebo comparator | Other: folic acid 400 mcgacid folic 400 mcg twice per day |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Obese pregnant women: BMI > 30 Kg/cm2
- first trimester fast glycaemia < 126 mg/dl
- single pregnancy
Key exclusion criteria (6 listed)
- Pregnant women with BMI < 30 Kg/cm2
- first trimester fast glycaemia > 126 mg/dl
- previous gestational diabetes
- twin pregnancy
- pregestational diabetes
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 |
|---|---|---|
| myo-inositolmyo-inositol 2 grams plus folic acid 400 mcg twice a day | Dietary supplement | myo-inositol |
| folic acid 400 mcg2 pills a day | Other | placebo |
Primary outcome
number of gestational diabetes cases diagnosed with OGTT
Time frame: 24-28th weeks gestation
difference in HOMA values
Time frame: from first trimester to OGTT
1 secondary outcome
incidence of pregnancy complications: hypertension, preterm delivery. macrosomia, shoulder dystocia, etc.
Time frame: at delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2014.
- 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.
- Derived from this study: PubMed 26241420D'Anna R, Di Benedetto A, Scilipoti A, Santamaria A, Interdonato ML, Petrella E, Neri I, Pintaudi B, Corrado F, Facchinetti F. Myo-inositol Supplementation for Prevention of Gestational Diabetes in Obese Pregnant Women: A Randomized Controlled Trial. Obstet Gynecol. 2015 Aug;126(2):310-315. doi: 10.1097/AOG.0000000000000958.
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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.
Rosario D'Anna, professor principal investigator
University of Messina, ITALY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myo-inositol and folic acid 400 mcg in people with Gestational Diabetes, run by University of Messina 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 6 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: finished, as of the sponsor's last update on 28 Feb 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of gestational diabetes cases diagnosed with OGTT (time frame: 24-28th weeks gestation). The study lists 2 primary outcomes in all. 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 NCT01047982, which also lists 2 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 28 Feb 2014.