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Myo-inositol Administration in Gestational Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Messina
Sponsor:
Information provided by (Responsible Party):
Rosario D'anna, University of Messina
ClinicalTrials.gov Identifier:
NCT00734448
First received: April 16, 2008
Last updated: June 12, 2014
Last verified: June 2014

April 16, 2008
June 12, 2014
November 2013
November 2014   (final data collection date for primary outcome measure)
Insulin sensitivity index (HOMA-IR) and continuous glucose monitoring profile [ Time Frame: Change from baseline in HOMA-IR at 8 weeks of treatment ] [ Designated as safety issue: No ]
Insulin sensitivity index (HOMA and QUICKI) [ Time Frame: At baseline and after 30 and 60 day of treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00734448 on ClinicalTrials.gov Archive Site
baby weight at delivery [ Time Frame: After delivery ] [ Designated as safety issue: No ]
Cardiovascular risk profile (serum lipoproteins, PCR, adiponectin and TNF-alfa), obstetric outcome (hypertensive disorders, macrosomia, cesarean section, neonatal hypoglycemia and jaundice requiring phototherapy) and dosage of insulin therapy. [ Time Frame: At baseline and after 30 and 60 days of treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Myo-inositol Administration in Gestational Diabetes
Effect of Myo-inositol Administration on Insulin Sensitivity in Gestational Diabetes Patients by Continuous Glucose Monitoring System (CGMS)

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Gestational Diabetes Mellitus
Dietary Supplement: myo-inositol
2 g twice a day until delivery
Experimental: A,1
Gestational diabetes patients who take myo-inositol
Intervention: Dietary Supplement: myo-inositol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2014
November 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Gestational diabetes diagnosed within 28 weeks
  • Caucasian pregnant women

Exclusion Criteria:

  • Non Caucasian pregnant women
  • Delivery before 8 weeks of treatment
Female
18 Years to 44 Years
Yes
Contact: rosario d'anna, professor 39-090-2211 ext 3809 rosariodanna@tin.it
Italy
 
NCT00734448
Myo-1954
No
Rosario D'anna, University of Messina
University of Messina
Not Provided
Principal Investigator: Rosario D'Anna, professor University of Messina, ITALY
University of Messina
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP