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Myo-inositol for Reduction of Insulin Therapy in Gestational Diabetes Mellitus (MYO-GDM)

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ClinicalTrials.gov Identifier: NCT03875755
Recruitment Status : Not yet recruiting
First Posted : March 15, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

Gestational diabetes mellitus (GDM) is defined as hyperglycemia first-diagnosed during pregnancy. Glycemic control reduces GDM-related complications. With the new diagnostic criteria of GDM, up to 25% of pregnant women have GDM, whereas it was previously 6-10% in France. Therefore caring for women with GDM is very time-consuming. Therapeutic strategy includes dietary and lifestyle measures and additional insulin therapy for 15 to 40% of the women with GDM if the glycemic targets are not achieved after a period of 1 to 2 weeks of diet. Insulin therapy is imperfect for the following main reasons: need for education (i.e. subcutaneous administration, dose titration), hypoglycemia and weight gain, limited acceptance and high cost. Psychosocial deprivation is associated with more cases of GDM and health accessibility may be unequal.

MYO-INOSITOL (MI) is an oral dietary supplement, which reduces insulin resistance. Women with GDM are deficient in MI. MI supplementation safely prevents GDM by 65 to 87% in high-risk women. A pilot study has shown a 75% reduction of the need for insulin during GDM not controlled by diet.

The coordinator investigator propose here, for the first time, a randomized controlled study evaluating MI versus placebo in women with newly diagnosed GDM.


Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus Dietary Supplement: Myo Inositol Other: Placebo Not Applicable

Detailed Description:

Prospective, multicenter, superiority, randomised, double blind study with two arms.

  1. In the 11 participating centers (9 in France and 2 in Belgium): selection of women with GDM between 12 and 34 weeks of gestation
  2. Explanation of protocol, with signature of consent in case of acceptation.
  3. Randomization

    • Experimental group: The women will receive 2 caps of MI with acid folic a day, until delivery
    • Control group: The women will receive 2 caps of placebo (containing only acid folic) a day, until delivery

    In both arms, the participants will be routinely followed up during pregnancy:

    • diet education,
    • self-monitoring of blood glucose before and after meals
    • and during follow-up insulin therapy if glucose value targets are unmet
  4. Routine monitoring of the women with GDM in both arms, up to delivery, without use of other oral hypoglycemic agents during pregnancy.

    At delivery:

    • MI (or placebo) will be stopped
    • Maternal blood samples will be collected at the same time as the sample routinely collected just before delivery for irregular agglutinin test measurement, when the women are perfused and cord fluid will be collected at the same as cord fluid pH is routinely measured just after delivery. The aliquots will be transported to the "Centre de Ressources Biologiques"(CRB) of the Jean Verdier Hospital
    • Events during pregnancy will be collected
  5. Last visit three months after delivery. Oral glucose tolerance test, anthropometric measures for women and their child.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1080 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double blind
Primary Purpose: Treatment
Official Title: Reduction of Insulin Therapy Under Myo-inositol for the Treatment of Gestational Diabetes Mellitus: a Randomized Multicenter and Prospective Trial. MYO-GDM Study
Estimated Study Start Date : June 15, 2019
Estimated Primary Completion Date : March 15, 2022
Estimated Study Completion Date : March 15, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Inositol

Arm Intervention/treatment
Experimental: Myo Inositol
The women will receive 2 caps of Myo Inositol with acid folic a day, until delivery
Dietary Supplement: Myo Inositol
One soft gel capsule containing MI 600 mg and folic acid 200 μg twice a day, until delivery.
Other Name: INOFOLIC

Placebo Comparator: Placebo
The women will receive 2 caps of placebo (acid folic) a day, until delivery
Other: Placebo
One soft gel capsule of placebo (folic acid 200 μg) twice a day until delivery.




Primary Outcome Measures :
  1. Rate of patients requiring insulin therapy during pregnancy [ Time Frame: At any time during pregnancy up to delivery; assessed up to 29 weeks. ]
    Rate of patients requiring insulin therapy (either basal or prandial). .


Secondary Outcome Measures :
  1. - Rate of patients requiring basal insulin therapy during pregnancy- /Rate of patients requiring prandial insulin therapy during pregnancy [ Time Frame: At any time during pregnancy up to delivery; assessed up to 29 weeks. ]
    This information will be retrieved from the glucose meter, and if not available, from the woman's diary

  2. - Doses of basal and prandial insulin at delivery- Gestation age when insulin is began - Duration of insulin treatment [ Time Frame: At delivery; assessed up to 29 weeks. ]
    • Dose of basal insulin (UI) at delivery, if any
    • Dose of prandial insulin (UI) at delivery, if any
    • Gestational age (SA) when basal insulin is started.
    • Gestational age (SA) when prandial insulin is started
    • Duration of basal insulin treatment at delivery, if any
    • Duration of prandial insulin treatment at delivery, if any

  3. Gestational weight gain [ Time Frame: At any time during pregnancy up to delivery; assessed up to 29 weeks. ]
    • Gestational weight gain (Kg) during pregnancy
    • Gestational weight gain (Kg) between inclusion and delivery

  4. Hypoglycemia [ Time Frame: from randomization to delivery; assessed up to 29 weeks. ]
    • Severe hypoglycemia: requiring assistance of another person to actively administer carbohydrates, glucagon, or take other corrective actions. Plasma Glucose concentrations may not be available during an event, but neurological recovery following the return of plasma/capillary glucose to normal is considered sufficient evidence that the event was induced by a low plasma/capillary glucose concentration.
    • Documented symptomatic hypoglycemia: event during which typical symptoms of hypoglycemia are accompanied by a measured capillary glucose concentration <70 mg/dL (<3.9 mmol/L).
    • Asymptomatic hypoglycemia: event not accompanied by typical symptoms of hypoglycemia but with a measured capillary glucose concentration <60 mg/dL (<3.3 mmol/L).

  5. Capillary glucose levels [ Time Frame: From the beginning of MI Supplementation to delivery;assessed up to 29 weeks. ]
    The women will be asked to perform 6 measures a day. Capillary glucose values will be retrieved from the glucose meter, and if not available, from the woman's diary.

  6. Neonatal complications [ Time Frame: At delivery; assessed up to 29 weeks ]
    • Birth weight ≥ 4000g; ≥ 4500g ; large and small for gestational age infant
    • Neonatal hypoglycemia defined as at least a blood glucose value lower than 2.0 mmol/l after 2 hours of life during the two first days of life if the newborn is asymptomatic
    • Shoulder dystocia, defined as vaginal cephalic delivery
    • Birth injury defined as plexus injury or clavicle fracture
    • Preterm delivery:
    • Late preterm infant (between 32 and 37 completed weeks' gestation)
    • Very preterm infant (28-31 completed weeks' gestation)
    • Extreme preterm infant (less than 28 completed weeks' gestation)
    • Low Apgar score: 5-min Apgar score < 7• Jaundice, defined as need for neonatal phototherapy • Neonatal respiratory distress syndrome, based on the clinical course, chest X-ray finding, blood gas and acid-base values • Medical need for admission to pediatric or neonatal intensive care unit during the three days following birth • Malformations: the types of malformation will be recorded.

  7. Preeclampsia - Pregnancy-induced hypertension - Cesarean section - Maternal inpatient admission during pregnancy [ Time Frame: At any time during pregnancy up to delivery; assessed up to 29 weeks. ]
    • Preeclampsia (blood pressure ≥ 140/90 mmHg on two measurements four hours apart and proteinuria of at least 300 mg/24 hours or 3+ or more on dipstick testing or proteinuria/creatinuria >30 in a random urine sample)
    • Pregnancy-induced hypertension: in women with no known hypertension before pregnancy, blood pressure ≥ 140/90 mmHg on two measurements four hours apart without proteinuria and having needed to begin anti-hypertensive therapy
    • Maternal inpatient admission during pregnancy after inclusion, not including hospitalization just after delivery

  8. Side effects [ Time Frame: From the beginning of MI Supplementation to delivery; assessed up to 29 weeks. ]
    The investigators expect MI not to have any side effect at the dose 1200 mg/day, but possible side effects will be collected.

  9. Results of oral glucose tolerance test [ Time Frame: 3 months after delivery ]
    Test will be performed by the women 3 months post partum

  10. Infant anthropometrics. [ Time Frame: At month 1, month 2 and month 3 ]
    These data will be collected from children's health record

  11. Acceptance/satisfaction of 2 strategies: score [ Time Frame: At delivery; assessed up to 29 weeks. ]
    Evaluation of the patient's satisfaction about their treatment for GDM at delivery : give a score of 0 to 100: 0 not satisfied; 100 totally satisfied

  12. Conservation of serum and plasma; cord fluid. The samples may be used for further analyses ancillary studies and which could be beneficial for GDM care based on evolution in scientific knowledge. [ Time Frame: within 10 years after the end of the study ]
    • The blood samples will be collected at the same time as the sample routinely collected just before delivery for irregular agglutinin test measurement.
    • Cord fluid will be collected



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The participants in this study are pregnant women with gestational diabetes mellitus.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years
  • Singleton pregnancy
  • GDM diagnosed during pregnancy according to IADPSG (International Association of the Diabetes and Pregnancy Study Groups) criteria, i.e.

    • fasting plasma glucose between 92 mg/dL (5.1 mmol/L) and 125 mg/dL (6.9 mmol/L)
    • and/or 1-hour plasma glucose value after 75 g oral glucose tolerance test (OGTT) ≥ 180 mg/dL (10.0 mmol/L)
    • and/or 2-hour plasma glucose value between 153 mg/dL (8.5 mmol/L) and 199 mg/dL ((11.0 mmol/L)
  • 12 to 34 weeks of gestation at the time of randomization
  • No more than 35 days after GDM diagnosis
  • Capacity for self-monitoring of blood glucose
  • Signed informed consent

Exclusion Criteria:

  • Insulin use before randomization during this pregnancy
  • Use of other oral hypoglycemic agents during this pregnancy
  • Long time corticosteroid treatment
  • Pre-existing diabetes before pregnancy
  • Overt diabetes diagnosed during pregnancy, i.e.

    • fasting plasma glucose ≥ 126 mg/dL (7 mmol/l)
    • and/or 2-hour post OGTT plasma glucose value ≥ 200 mg/dL (11.1 mmol/L)
  • Lack of Social Insurance
  • Insufficient French understanding and speaking
  • Participant in another investigational drug study at inclusion visit
  • Fetal malformation diagnosed by previous fetal ultrasound
  • Personal history of any bariatric surgery
  • Hypersensitivity to any ingredient of dietary supplement formulation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03875755


Contacts
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Contact: Emmanuel COSSON, MD-PhD 1 48 02 65 80 ext 33 emmanuel.cosson@aphp.fr
Contact: Vanessa LUBIN 4 42 91 52 52 ext 33 vanessa.lubin@gmail.com

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Emmanuel COSSON, MD-PhD Assistance Publique - Hôpitaux de Paris

Publications:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03875755     History of Changes
Other Study ID Numbers: P160940J
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Diabetes
Pregnancy
MYO-INOSITOL
Oral supplementation

Additional relevant MeSH terms:
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Inositol
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs