Inositol Stereoisomers to Treat Gestational Diabetes

March 23, 2014 updated by: Ester Vitacolonna, Università degli Studi 'G. d'Annunzio' Chieti e Pescara

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).

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Chieti, Italy, 66100
        • Hospital "SS Annunziata"
        • Contact:
        • Principal Investigator:
          • Ester Vitacolonna, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Pre-pregnancy diabetes
  • Non-singleton pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Insulin resistance level evaluated by homeostasis model assessment of insulin resistance (HOMA-IR)
Time Frame: 56 days- 8 weeks
56 days- 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
hypertensive disorders
Time Frame: 56 days- 8 weeks
56 days- 8 weeks
macrosomia
Time Frame: at delivery
at delivery
cesarean section
Time Frame: at delivery
at delivery
neonatal hypoglycemia
Time Frame: at delivery
at delivery
jaundice requiring phototherapy
Time Frame: within the first 2 weeks after delivery
within the first 2 weeks after delivery
lipid profile
Time Frame: 56 days- 8 weeks
56 days- 8 weeks
insulin therapy requirements
Time Frame: 56 days- 8 weeks
56 days- 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi 'G. d'Annunzio' Chieti e Pescara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

April 1, 2015

Study Registration Dates

First Submitted

February 27, 2014

First Submitted That Met QC Criteria

March 23, 2014

First Posted (Estimate)

March 26, 2014

Study Record Updates

Last Update Posted (Estimate)

March 26, 2014

Last Update Submitted That Met QC Criteria

March 23, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VITA01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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