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Inositol Stereoisomers to Treat Gestational Diabetes

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ClinicalTrials.gov Identifier: NCT02097069
Recruitment Status : Unknown
Verified March 2014 by Ester Vitacolonna, Università degli Studi 'G. d'Annunzio' Chieti e Pescara.
Recruitment status was:  Not yet recruiting
First Posted : March 26, 2014
Last Update Posted : March 26, 2014
Sponsor:
Information provided by (Responsible Party):
Ester Vitacolonna, Università degli Studi 'G. d'Annunzio' Chieti e Pescara

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus Dietary Supplement: Folic acid Dietary Supplement: Myo-inositol Dietary Supplement: D-Chiro-inositol Dietary Supplement: Myo-inositol plus D-chiro inositol Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Different Effects of Inositol Stereoisomers on Insulin Sensitivity in Women With Gestational Diabetes
Study Start Date : April 2014
Estimated Primary Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Folic Acid
Drug Information available for: Inositol

Arm Intervention/treatment
Subgroup A
folic acid 400 mcg/day
Dietary Supplement: Folic acid
Folic acid 400 mcg/day

Experimental: Subgroup B
myo-inositol 2000 mg twice a day
Dietary Supplement: Myo-inositol
myo-inositol 2000 mg twice a day

Experimental: Subgroup C
D-chiro-inositol 250 mg twice a day
Dietary Supplement: D-Chiro-inositol
D-chiro inositol 250 mg twice a day

Experimental: Subgroup D
Myo-inositol plus D-chiro inositol 550mg/13,8 mg twice a day
Dietary Supplement: Myo-inositol plus D-chiro inositol
Myo-inositol plus D-chiro inositol 550mg/13,8 mg twice a day




Primary Outcome Measures :
  1. Insulin resistance level evaluated by homeostasis model assessment of insulin resistance (HOMA-IR) [ Time Frame: 56 days- 8 weeks ]

Secondary Outcome Measures :
  1. hypertensive disorders [ Time Frame: 56 days- 8 weeks ]
  2. macrosomia [ Time Frame: at delivery ]
  3. cesarean section [ Time Frame: at delivery ]
  4. neonatal hypoglycemia [ Time Frame: at delivery ]
  5. jaundice requiring phototherapy [ Time Frame: within the first 2 weeks after delivery ]
  6. lipid profile [ Time Frame: 56 days- 8 weeks ]
  7. insulin therapy requirements [ Time Frame: 56 days- 8 weeks ]


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:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gestational Diabetes diagnosed within 24-28 weeks gestation
  • Caucasian pregnant women

Exclusion Criteria:

  • Pre-pregnancy diabetes
  • Non-singleton pregnancy

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): NCT02097069


Locations
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Italy
Hospital "SS Annunziata" Not yet recruiting
Chieti, Italy, 66100
Contact: Ester Vitacolonna, Professor    +393398073446    e.vitacolonna@unich.it   
Principal Investigator: Ester Vitacolonna, Professor         
Sponsors and Collaborators
Università degli Studi 'G. d'Annunzio' Chieti e Pescara

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ester Vitacolonna, Professor Ester Vitacolonna, Università degli Studi 'G. d'Annunzio' Chieti e Pescara
ClinicalTrials.gov Identifier: NCT02097069     History of Changes
Other Study ID Numbers: VITA01
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014

Keywords provided by Ester Vitacolonna, Università degli Studi 'G. d'Annunzio' Chieti e Pescara:
Gestational diabetes mellitus
Myo-inositol
D-chiro-inositol
Insulin resistance

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