Gestational Diabetes MellitusNCT02097069
Inositol Stereoisomers to Treat Gestational Diabetes
A study testing Folic acid, Myo-inositol and D-Chiro-inositol in people with Gestational Diabetes Mellitus, run by Università degli Studi 'G. d'Annunzio' Chieti e Pescara at 1 site in Italy.
Trial summary
The investigators aim to compare the effect of different inositol stereoisomers supplementation in lowering insulin resistance levels after 8 weeks of treatment in pregnant women with GDM and in preventing adverse obstetric outcomes. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Folic acid, Myo-inositol and D-Chiro-inositol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2014to Apr 2015
- 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
- Gestational Diabetes diagnosed within 24-28 weeks gestation
- Caucasian pregnant women
Who cannot join
- Pre-pregnancy diabetes
- Non-singleton pregnancy
Trial locations and contacts
1 site in 1 country.
Italy1 site
Hospital "SS Annunziata"
Chieti, Chieti, 66100
Ester Vitacolonna, Professor, +393398073446, e.vitacolonna@unich.it
Ester Vitacolonna, Professor
About this study
Official title: Different Effects of Inositol Stereoisomers on Insulin Sensitivity in Women With Gestational Diabetes
The investigators aim to compare the effect of different inositol stereoisomers supplementation in lowering insulin resistance levels after 8 weeks of treatment in pregnant women with GDM and in preventing adverse obstetric outcomes.
The study population includes 80 women with GDM, randomly allocated to subgroup A (folic acid 400 mcg/day), subgroup B (myo-inositol 2000 mg twice a day), subgroup C (D-chiro-inositol 250 mg twice a day), and subgroup D (Myo-inositol plus D-chiro-inositol 550mg/13,8 mg twice a day).
Read more
Folic acid or inositol stereoisomers will be administered starting at the enrolling time (24-28 week gestation, after GDM diagnosis) till the delivery.
The homeostasis model assessment of insulin resistance (HOMA-IR) and the sensitivity index (QUICKI) will be checked at the moment of the diagnostic oral glucose tolerance test (24-28 weeks) and after 8 weeks of treatment. Obstetric outcomes, the rate of women needed insulin therapy and insulin dosage will be registered.
Read the detailed description
Gestational diabetes mellitus (GDM) is defined as carbohydrate intolerance that begins or is first recognized during pregnancy (1). It is characterized by an increase of physiological insulin resistance and it is associated with an increased risk of perinatal and maternal morbidity (2,3).
Inositol is a six-carbon polyol, normally present in a variety of foods, which has been classified as an insulin sensitizing agent. It exists as nine different isomers including myo-inositol (MI) and D-chiro-inositol (DCI) that are the most represented in human body. Myo-inositol and D-chiro-inositol glycans administration has been reported to exert beneficial effects at metabolic, hormonal and ovarian levels (4-5).
Recently has been demonstrated that Myo-inositol supplementation improves insulin resistance in patients with GDM (6), whereas there aren't data about the use of D-chiro-inositol or Myo-inositol plus D-chiro-inositol in women affected by GDM.
In this proposed study, the investigators aim to compare the effect of different inositol stereoisomers supplementation (Myo-inositol, D-chiro-inositol or Myo-inositol plus D-chiro-inositol ) in lowering insulin resistance levels after 8 weeks of treatment in pregnant women with GDM and in preventing adverse obstetric outcomes. All the available inositol formulations also contain folic acid (200 mcg).
The study population includes 80 women with GDM, randomly allocated to subgroup A (folic acid 400 mcg/day), subgroup B (myo-inositol 2000 mg twice a day), subgroup C (D-chiro-inositol 250 mg twice a day), and subgroup D (Myo-inositol plus D-chiro-inositol 550mg/13,8 mg twice a day).
Dietary control, folic acid or inositol stereoisomers will be administered starting at the enrolling time (24-28 week gestation, after GDM diagnosis) till the delivery.
The homeostasis model assessment of insulin resistance (HOMA-IR) and the sensitivity index (QUICKI) will be checked at the moment of the diagnostic oral glucose tolerance test (24-28 weeks) and after 8 weeks of treatment. Obstetric outcomes, the rate of women needed insulin therapy and insulin dosage will be registered.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Folic acid, Myo-inositol, D-Chiro-inositol, Myo-inositol plus D-chiro inositol
- Keywords
- Gestational diabetes mellitus, Myo-inositol, D-chiro-inositol, Insulin resistance
- Medical subject headings
- Diabetes, Gestational, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic acidDietary supplement
Folic acid 400 mcg/day
Myo-inositolDietary supplement
myo-inositol 2000 mg twice a day
D-Chiro-inositolDietary supplement
D-chiro inositol 250 mg twice a day
Myo-inositol plus D-chiro inositolDietary supplement
Myo-inositol plus D-chiro inositol 550mg/13,8 mg twice a day
| Study group | Role | What they receive |
|---|---|---|
| Subgroup A | Other | folic acid 400 mcg/day Receives: Dietary Supplement: Folic acid |
| Subgroup B | Experimental | myo-inositol 2000 mg twice a day Receives: Dietary Supplement: Myo-inositol |
| Subgroup C | Experimental | D-chiro-inositol 250 mg twice a day Receives: Dietary Supplement: D-Chiro-inositol |
| Subgroup D | Experimental | Myo-inositol plus D-chiro inositol 550mg/13,8 mg twice a day Receives: Dietary Supplement: Myo-inositol plus D-chiro inositol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin resistance level evaluated by homeostasis model assessment of insulin resistance (HOMA-IR)
Measured: 56 days- 8 weeks
Secondary outcomes (7)
hypertensive disorders
Measured: 56 days- 8 weeks
macrosomia
Measured: at delivery
cesarean section
Measured: at delivery
neonatal hypoglycemia
Measured: at delivery
jaundice requiring phototherapy
Measured: within the first 2 weeks after delivery
lipid profile
Measured: 56 days- 8 weeks
insulin therapy requirements
Measured: 56 days- 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi 'G. d'Annunzio' Chieti e Pescara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ester Vitacolonna, Università degli Studi 'G. d'Annunzio' Chieti e Pescara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097069
- Sponsor's protocol ID
- VITA01
- Status last verified
- Mar 2014
- First submitted
- 27 Feb 2014
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Metzger BE, Coustan DR. Summary and recommendations of the Fourth International Workshop-Conference on Gestational Diabetes Mellitus. The Organizing Committee. Diabetes Care. 1998 Aug;21 Suppl 2:B161-7. No abstract available.
PubMed 9704245Casey BM, Lucas MJ, Mcintire DD, Leveno KJ. Pregnancy outcomes in women with gestational diabetes compared with the general obstetric population. Obstet Gynecol. 1997 Dec;90(6):869-73. doi: 10.1016/s0029-7844(97)00542-5.
PubMed 9397092Jovanovic L, Pettitt DJ. Gestational diabetes mellitus. JAMA. 2001 Nov 28;286(20):2516-8. doi: 10.1001/jama.286.20.2516. No abstract available.
PubMed 11722247Nestler JE, Jakubowicz DJ, Reamer P, Gunn RD, Allan G. Ovulatory and metabolic effects of D-chiro-inositol in the polycystic ovary syndrome. N Engl J Med. 1999 Apr 29;340(17):1314-20. doi: 10.1056/NEJM199904293401703.
PubMed 10219066Croze ML, Soulage CO. Potential role and therapeutic interests of myo-inositol in metabolic diseases. Biochimie. 2013 Oct;95(10):1811-27. doi: 10.1016/j.biochi.2013.05.011. Epub 2013 Jun 10.
PubMed 23764390Corrado 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 21414183Fraticelli F, Celentano C, Zecca IA, Di Vieste G, Pintaudi B, Liberati M, Franzago M, Di Nicola M, Vitacolonna E. Effect of inositol stereoisomers at different dosages in gestational diabetes: an open-label, parallel, randomized controlled trial. Acta Diabetol. 2018 Aug;55(8):805-812. doi: 10.1007/s00592-018-1157-4. Epub 2018 May 17.
PubMed 29774465
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Effects of Inositol Stereoisomers on Insulin Sensitivity in Women With Gestational Diabetes
- ClinicalTrials.gov ID
- NCT02097069
- Acronym / sponsor ID
- VITA01
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- Gestational diabetes mellitus, Myo-inositol, D-chiro-inositol, Insulin resistance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Università degli Studi 'G. d'Annunzio' Chieti e PescaraUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2015 (estimated)
- First posted
- 26 Mar 2014 (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 investigators aim to compare the effect of different inositol stereoisomers supplementation in lowering insulin resistance levels after 8 weeks of treatment in pregnant women with GDM and in preventing adverse obstetric outcomes.
The study population includes 80 women with GDM, randomly allocated to subgroup A (folic acid 400 mcg/day), subgroup B (myo-inositol 2000 mg twice a day), subgroup C (D-chiro-inositol 250 mg twice a day), and subgroup D (Myo-inositol plus D-chiro-inositol 550mg/13,8 mg twice a day).
Folic acid or inositol stereoisomers will be administered starting at the enrolling time (24-28 week gestation, after GDM diagnosis) till the delivery.
The homeostasis model assessment of insulin resistance (HOMA-IR) and the sensitivity index (QUICKI) will be checked at the moment of the diagnostic oral glucose tolerance test (24-28 weeks) and after 8 weeks of treatment. Obstetric outcomes, the rate of women needed insulin therapy and insulin dosage will be registered.
Detailed description
Gestational diabetes mellitus (GDM) is defined as carbohydrate intolerance that begins or is first recognized during pregnancy (1). It is characterized by an increase of physiological insulin resistance and it is associated with an increased risk of perinatal and maternal morbidity (2,3).
Inositol is a six-carbon polyol, normally present in a variety of foods, which has been classified as an insulin sensitizing agent. It exists as nine different isomers including myo-inositol (MI) and D-chiro-inositol (DCI) that are the most represented in human body. Myo-inositol and D-chiro-inositol glycans administration has been reported to exert beneficial effects at metabolic, hormonal and ovarian levels (4-5).
Recently has been demonstrated that Myo-inositol supplementation improves insulin resistance in patients with GDM (6), whereas there aren't data about the use of D-chiro-inositol or Myo-inositol plus D-chiro-inositol in women affected by GDM.
In this proposed study, the investigators aim to compare the effect of different inositol stereoisomers supplementation (Myo-inositol, D-chiro-inositol or Myo-inositol plus D-chiro-inositol ) in lowering insulin resistance levels after 8 weeks of treatment in pregnant women with GDM and in preventing adverse obstetric outcomes. All the available inositol formulations also contain folic acid (200 mcg).
The study population includes 80 women with GDM, randomly allocated to subgroup A (folic acid 400 mcg/day), subgroup B (myo-inositol 2000 mg twice a day), subgroup C (D-chiro-inositol 250 mg twice a day), and subgroup D (Myo-inositol plus D-chiro-inositol 550mg/13,8 mg twice a day).
Dietary control, folic acid or inositol stereoisomers will be administered starting at the enrolling time (24-28 week gestation, after GDM diagnosis) till the delivery.
The homeostasis model assessment of insulin resistance (HOMA-IR) and the sensitivity index (QUICKI) will be checked at the moment of the diagnostic oral glucose tolerance test (24-28 weeks) and after 8 weeks of treatment. Obstetric outcomes, the rate of women needed insulin therapy and insulin dosage will be registered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Subgroup A | Other | Dietary Supplement: Folic acidfolic acid 400 mcg/day |
| Subgroup B | Experimental | Dietary Supplement: Myo-inositolmyo-inositol 2000 mg twice a day |
| Subgroup C | Experimental | Dietary Supplement: D-Chiro-inositolD-chiro-inositol 250 mg twice a day |
| Subgroup D | Experimental | Dietary Supplement: Myo-inositol plus D-chiro inositolMyo-inositol plus D-chiro inositol 550mg/13,8 mg twice a day |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Gestational Diabetes diagnosed within 24-28 weeks gestation
- Caucasian pregnant women
Key exclusion criteria (2 listed)
- Pre-pregnancy diabetes
- Non-singleton pregnancy
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 |
|---|---|---|
| Folic acidFolic acid 400 mcg/day | Dietary supplement | Subgroup A |
| Myo-inositolmyo-inositol 2000 mg twice a day | Dietary supplement | Subgroup B |
| D-Chiro-inositolD-chiro inositol 250 mg twice a day | Dietary supplement | Subgroup C |
| Myo-inositol plus D-chiro inositolMyo-inositol plus D-chiro inositol 550mg/13,8 mg twice a day | Dietary supplement | Subgroup D |
Primary outcome
Insulin resistance level evaluated by homeostasis model assessment of insulin resistance (HOMA-IR)
Time frame: 56 days- 8 weeks
7 secondary outcomes
hypertensive disorders
Time frame: 56 days- 8 weeks
macrosomia
Time frame: at delivery
cesarean section
Time frame: at delivery
neonatal hypoglycemia
Time frame: at delivery
jaundice requiring phototherapy
Time frame: within the first 2 weeks after delivery
lipid profile
Time frame: 56 days- 8 weeks
insulin therapy requirements
Time frame: 56 days- 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
- Background: PubMed 9704245Metzger BE, Coustan DR. Summary and recommendations of the Fourth International Workshop-Conference on Gestational Diabetes Mellitus. The Organizing Committee. Diabetes Care. 1998 Aug;21 Suppl 2:B161-7. No abstract available.
- Background: PubMed 9397092Casey BM, Lucas MJ, Mcintire DD, Leveno KJ. Pregnancy outcomes in women with gestational diabetes compared with the general obstetric population. Obstet Gynecol. 1997 Dec;90(6):869-73. doi: 10.1016/s0029-7844(97)00542-5.
- Background: PubMed 11722247Jovanovic L, Pettitt DJ. Gestational diabetes mellitus. JAMA. 2001 Nov 28;286(20):2516-8. doi: 10.1001/jama.286.20.2516. No abstract available.
- Background: PubMed 10219066Nestler JE, Jakubowicz DJ, Reamer P, Gunn RD, Allan G. Ovulatory and metabolic effects of D-chiro-inositol in the polycystic ovary syndrome. N Engl J Med. 1999 Apr 29;340(17):1314-20. doi: 10.1056/NEJM199904293401703.
- Background: PubMed 23764390Croze ML, Soulage CO. Potential role and therapeutic interests of myo-inositol in metabolic diseases. Biochimie. 2013 Oct;95(10):1811-27. doi: 10.1016/j.biochi.2013.05.011. Epub 2013 Jun 10.
- 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 29774465Fraticelli F, Celentano C, Zecca IA, Di Vieste G, Pintaudi B, Liberati M, Franzago M, Di Nicola M, Vitacolonna E. Effect of inositol stereoisomers at different dosages in gestational diabetes: an open-label, parallel, randomized controlled trial. Acta Diabetol. 2018 Aug;55(8):805-812. doi: 10.1007/s00592-018-1157-4. Epub 2018 May 17.
Related trials for Gestational Diabetes Mellitus
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Folic acid, Myo-inositol and D-Chiro-inositol in people with Gestational Diabetes Mellitus, run by Università degli Studi 'G. d'Annunzio' Chieti e Pescara 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 2 inclusion and 2 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 26 Mar 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin resistance level evaluated by homeostasis model assessment of insulin resistance (HOMA-IR) (time frame: 56 days- 8 weeks). 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 NCT02097069, which also lists 7 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 26 Mar 2014.