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Myo-inositol Administration in Gestational Diabetes

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ClinicalTrials.gov Identifier: NCT00734448
Recruitment Status : Unknown
Verified June 2014 by Rosario D'anna, University of Messina.
Recruitment status was:  Recruiting
First Posted : August 14, 2008
Last Update Posted : June 13, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Myo-Inositol is an insulin sensitizing agent that ameliorate the insulin resistance in women affected by gestational diabetes (GDM), but there is no information about the effect on the glucose profile. Maternal hyperglycemia of GDM, especially hypoglycemic excursions, are associated with adverse pregnancy outcome. Continuous Glucose Monitoring System (CGMS) is obviously better than intermittent self monitoring in detecting glucose profile and magnitude and duration of glucose fluctuations. For this reason, we propose a clinical trial to analyze the characteristics of glucose variability in GDM women,treated with diet and folic acid alone or with diet, folic acid and myo-inositol supplementation.

Condition or disease Intervention/treatment
Gestational Diabetes Mellitus Dietary Supplement: myo-inositol

Detailed Description:
Our study is a randomized, prospective, controlled trial, including the first 30 consecutive Caucasian gestational diabetes patients diagnosed,according the International Association of Diabetes and Pregnancy Study Group (IADPSG) panel criteria, from November 2013 in the Department of Obstetric and Gynecology of Messina University (ITALY). After an informed consent they will be randomly assigned to receive (n. 15) diet and folic acid (400 mcg per day) alone or (n. 15) diet, folic acid (400 mcg per day) and myo-inositol (2 g. twice a day)supplementation. The insulin sensitivity index (HOMA-IR) and the glycemic profile will be monitor by CGMS for each patient at GDM diagnosis and after 8 weeks of treatment The pregnant women who will delivery before the time treatment (8 weeks) or who need insulin will be excluded.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of Myo-inositol Administration on Insulin Sensitivity in Gestational Diabetes Patients by Continuous Glucose Monitoring System (CGMS)
Study Start Date : November 2013
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Inositol
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A,1
Gestational diabetes patients who take myo-inositol
Dietary Supplement: myo-inositol
2 g twice a day until delivery


Outcome Measures

Primary Outcome Measures :
  1. Insulin sensitivity index (HOMA-IR) and continuous glucose monitoring profile [ Time Frame: Change from baseline in HOMA-IR at 8 weeks of treatment ]

Secondary Outcome Measures :
  1. baby weight at delivery [ Time Frame: After delivery ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Gestational diabetes diagnosed within 28 weeks
  • Caucasian pregnant women

Exclusion Criteria:

  • Non Caucasian pregnant women
  • Delivery before 8 weeks of treatment
Contacts and Locations

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): NCT00734448


Contacts
Contact: rosario d'anna, professor 39-090-2211 ext 3809 rosariodanna@tin.it

Locations
Italy
University of Messina - Recruiting
Messina, Sicilia, Italy, 98100
Contact: francesco corrado, researcher    39-090-2211 ext 2176    francesco.corrado@unime.it   
Principal Investigator: rosario d'anna, professor         
Sub-Investigator: francesco corrado, researcher         
Sponsors and Collaborators
University of Messina
Investigators
Principal Investigator: Rosario D'Anna, professor University of Messina, ITALY
More Information

Responsible Party: Rosario D'anna, associate professor, University of Messina
ClinicalTrials.gov Identifier: NCT00734448     History of Changes
Other Study ID Numbers: Myo-1954
First Posted: August 14, 2008    Key Record Dates
Last Update Posted: June 13, 2014
Last Verified: June 2014

Keywords provided by Rosario D'anna, University of Messina:
gestational diabetes mellitus
carbohydrate intolerance
myo-inositol
insulin resistance

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