GDMNCT01762826
Myo-inositol, D-chiro-inositol, and D-chiro/Myo-inositol in Gestational Diabetes
An observational study of GDM, run by G. d'Annunzio University.
Trial summary
Comparison of different inositol stereoisomears in preventing adverse obstetric outcomes in non-obese pregnant women at high risk for gestational diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- GDM
- What is being tested?
- Myo-inositol, D-chiro-inositol and D-Chiro / Myo-inositol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Sep 2013
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult
Study population: Non obese pregnant women during first trimester of pregnancy with scared fasting glucose (above 92 mg%)
Who may be able to join
- pregnancy below 20 weeks gestation BMI below 30 Fasting glucose between 92 and 126 mg% Singleton pregnancy Naturally conceived
Who cannot join
- obese patient Fasti g glucose above 126 or below 92
About this study
Official title: Adverse Obstetric Outcomes in Gestational Diabetes Mellitus and Inositol Stereoisomears
Comparison of different inositol stereoisomears in preventing adverse obstetric outcomes in non-obese pregnant women at high risk for gestational diabetes mellitus.
Read the detailed description
The investigators compared outcomes from metabolic and obstetric point of view in GDM pregnant non-obese patient with different stereoisomears of inositol supply. Dietary control and placebo or inositol steroisomears were administered starting at the enrolling time (first fasting oral glucose above 92 mg%; usually before 20 weeks gestations') till the delivery and/or pregnancy end/termination. Oral glucose tolerance test results at 24-28 weeks' gestation was evaluated (as glucose values and oGTT screening). Fetal growth, delivery data, obstetric outcomes and necessity of insulin therapy were taken into account.
- Conditions
- GDM
- Being tested
- Myo-inositol, D-chiro-inositol, D-Chiro / Myo-inositol, Placebo
- Keywords
- Inositol, GDM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myo-inositolDietary supplement
Also called Supplementation of myo-inositol plus dietary control
Dietary control plus Myo-inositol
D-chiro-inositolDietary supplement
Dietary control plus D-Chiro-Inositol supplementation
D-Chiro / Myo-inositolDietary supplement
Dietary control Supplementation with myo and d-chiro inositol
PlaceboDietary supplement
Dietary control plus folic acid 400 mcg daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo control | Diet pills of 400 mcg of acid folic daily Receives: Dietary Supplement: Placebo | |
| D-chiro-inositol / Myo-inositol | Diet sachets 2000 mg myo-inositol and 250 mg d-chiro-inositol and 400 mcg folic acid daily Receives: Dietary Supplement: D-Chiro / Myo-inositol | |
| D-chiro-inositol | Diet pills with 500 mg d-chiro-inositol and 400 mcg folic acid daily Receives: Dietary Supplement: D-chiro-inositol | |
| Myo-inositol | Diet sachets with 2000 mg myo-inositol and 200 mcg folic acid twice daily Receives: Dietary Supplement: Myo-inositol |
What is being measured
The primary outcome is the main question the study is designed to answer.
OGTT result
OGTT is the mainstay of obstetric outcomes in GDM
Measured: 24-28 weeks' gestation
Secondary outcomes (3)
Fetal measurements at third trimester
Centiles of fetal measurements and amniotic fluid volume
Measured: 28 weeks
Delivery data
Gestational age at delivery Route of delivery Fetal gender Fetal weight (grams and centiles) Neonatal hypoglycemia
Measured: 25-42 weeks gestations'
Adverse obstetric outcome
Abortion Preterm delivery Polyhydramnios IUGR Macrosomia Fetal distress Preterm delivery pPROM Neonatal morbility (NICU stay, low glucose levels, etc.) Neonatal mortality Cerebral palsy Route of delivery Dystocia Etc.
Measured: from first elevated oral fasting glucose (above 92 mg%) till the end/termination of pregnancy (latter 42 weeks gestation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2013 (estimated)
- Study startSep 2012
- Primary completionApr 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GDMStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chieti
- Responsible party
- Principal investigator, Claudio Celentano, G. d'Annunzio University
- Investigators
- Claudio Celentano, MD, Study director, ObGyn Dept University of ChietiBarbara Matarrelli, MD, Principal investigator, ObGyn Dept Univ of ChietiEster Vitacolonna, MD, Study chair, Diabetology Dept Univ of Chieti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762826
- Sponsor's protocol ID
- INOS002
- Status last verified
- Sep 2012
- First submitted
- 25 Nov 2012
- Last updated
- 8 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adverse Obstetric Outcomes in Gestational Diabetes Mellitus and Inositol Stereoisomears
- ClinicalTrials.gov ID
- NCT01762826
- Acronym / sponsor ID
- INOS002
- Conditions
- GDM
- Keywords
- Inositol, GDM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Collaborators
- University of Chieti
- Study start
- Sep 2012
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 8 Jan 2013 (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.
Comparison of different inositol stereoisomears in preventing adverse obstetric outcomes in non-obese pregnant women at high risk for gestational diabetes mellitus.
Detailed description
The investigators compared outcomes from metabolic and obstetric point of view in GDM pregnant non-obese patient with different stereoisomears of inositol supply. Dietary control and placebo or inositol steroisomears were administered starting at the enrolling time (first fasting oral glucose above 92 mg%; usually before 20 weeks gestations') till the delivery and/or pregnancy end/termination. Oral glucose tolerance test results at 24-28 weeks' gestation was evaluated (as glucose values and oGTT screening). Fetal growth, delivery data, obstetric outcomes and necessity of insulin therapy were taken into account.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo control | – | Dietary Supplement: PlaceboDiet pills of 400 mcg of acid folic daily |
| D-chiro-inositol / Myo-inositol | – | Dietary Supplement: D-Chiro / Myo-inositolDiet sachets 2000 mg myo-inositol and 250 mg d-chiro-inositol and 400 mcg folic acid daily |
| D-chiro-inositol | – | Dietary Supplement: D-chiro-inositolDiet pills with 500 mg d-chiro-inositol and 400 mcg folic acid daily |
| Myo-inositol | – | Dietary Supplement: Myo-inositolDiet sachets with 2000 mg myo-inositol and 200 mcg folic acid twice daily |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Non obese pregnant women during first trimester of pregnancy with scared fasting glucose (above 92 mg%)
Key inclusion criteria (1 listed)
- pregnancy below 20 weeks gestation BMI below 30 Fasting glucose between 92 and 126 mg% Singleton pregnancy Naturally conceived
Key exclusion criteria (1 listed)
- obese patient Fasti g glucose above 126 or below 92
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-inositolAlso: Supplementation of myo-inositol plus dietary controlDietary control plus Myo-inositol | Dietary supplement | Myo-inositol |
| D-chiro-inositolDietary control plus D-Chiro-Inositol supplementation | Dietary supplement | D-chiro-inositol |
| D-Chiro / Myo-inositolDietary control Supplementation with myo and d-chiro inositol | Dietary supplement | D-chiro-inositol / Myo-inositol |
| PlaceboDietary control plus folic acid 400 mcg daily | Dietary supplement | Placebo control |
Primary outcome
OGTT result
Time frame: 24-28 weeks' gestation
OGTT is the mainstay of obstetric outcomes in GDM
3 secondary outcomes
Fetal measurements at third trimester
Time frame: 28 weeks
Delivery data
Time frame: 25-42 weeks gestations'
Adverse obstetric outcome
Time frame: from first elevated oral fasting glucose (above 92 mg%) till the end/termination of pregnancy (latter 42 weeks gestation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2013.
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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.
Claudio Celentano, MD study director
ObGyn Dept University of Chieti
Barbara Matarrelli, MD principal investigator
ObGyn Dept Univ of Chieti
Ester Vitacolonna, MD study chair
Diabetology Dept Univ of Chieti
Questions about this trial
What is this clinical trial studying?
An observational study of GDM, run by G. d'Annunzio University.
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 1 inclusion and 1 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 8 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
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?
OGTT result (time frame: 24-28 weeks' gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2013.