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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
Recruitment status was: Recruiting
Sponsor:
University of Messina
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
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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: 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) |
Resource links provided by NLM:
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00734448
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 September 19, 2017