Myo-inositol Administration in Gestational Diabetes

This study is currently recruiting participants.
Verified February 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: February 27, 2014
Last verified: February 2014
  Purpose

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 Intervention
Gestational Diabetes Mellitus
Dietary Supplement: myo-inositol

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by University of Messina:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • baby weight at delivery [ Time Frame: After delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A,1
Gestational diabetes patients who take myo-inositol
Dietary Supplement: myo-inositol
2 g twice a day until delivery

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.

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Rosario D'anna, associate professor, University of Messina
ClinicalTrials.gov Identifier: NCT00734448     History of Changes
Other Study ID Numbers: Myo-1954
Study First Received: April 16, 2008
Last Updated: February 27, 2014
Health Authority: Italy: National Institute of Health

Keywords provided by University of Messina:
gestational diabetes mellitus
carbohydrate intolerance
myo-inositol
insulin resistance

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

ClinicalTrials.gov processed this record on April 17, 2014