Myo-inositol Administration in Gestational Diabetes

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified June 2014 by Rosario D'anna, University of Messina.
Recruitment status was: Recruiting

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

History of Changes

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:	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:

Drug Information available for: Inositol

Genetic and Rare Diseases Information Center resources: Glucose-galactose Malabsorption

U.S. FDA Resources

Further study details as provided by Rosario D'anna, 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 ]

Secondary Outcome Measures:

baby weight at delivery [ Time Frame: After delivery ]


Estimated Enrollment:	30
Study Start Date:	November 2013
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	November 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 (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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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:	June 12, 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

ClinicalTrials.gov processed this record on May 25, 2017

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