Myo-Inositol Administration in Gestational Diabetes
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | April 16, 2008 | ||||
| Last Updated Date | February 17, 2009 | ||||
| Start Date ICMJE | July 2008 | ||||
| Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Insulin sensitivity index (HOMA and QUICKI) [ Time Frame: At baseline and after 30 and 60 day of treatment ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00734448 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Myo-Inositol Administration in Gestational Diabetes | ||||
| Official Title ICMJE | Effect of Myo-Inositol Administration on Insulin Sensitivity in Gestational Diabetes Patients | ||||
| Brief Summary | Myo-Inositol is classified as a member of the vitamin B complex. It is a constituent of living cells and is widespread in many food. It is involved in a number of biological processes, including insulin signal transduction, resulting in modulating insulin sensitivity. From literature, the investigators know that myo-inositol positively affects insulin resistance in polycystic ovary syndrome patients restoring spontaneous ovarian activity. So the investigators hypothesize that the administration of 2 g, twice a day, would improve the insulin-receptor activity also in pregnant women affected by gestational diabetes. |
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| Detailed Description | Our study is a randomized, prospective, controlled trial, including all consecutive Caucasian gestational diabetes patients diagnosed,according the Carpenter's criteria, from April to December 2008 in the Department of Obstetric and Gynecology fo University of Messina. After an informed consent they will be enrolled in the study and myo-inositol, combined with folic acid, will be administered 2 g twice a day. The insulin sensitivity index (HOMA and QUICKI) will be checked at baseline (fasting GTT at 26-28 weeks) and after 30 and 60 days of treatment. Cardiovascular risk profile, obstetric outcome and dosage of insulin therapy will be registered. The pregnant women who will delivery before 36 weeks of gestation will be excluded. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Supportive Care |
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| Condition ICMJE | Gestational Diabetes Mellitus | ||||
| Intervention ICMJE | Dietary Supplement: myo-inositol
2 g twice a day until delivery |
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| Study Arm (s) | Experimental: A,1
Gestational diabetes patients who take myo-inositol
Intervention: Dietary Supplement: myo-inositol |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Estimated Completion Date | December 2009 | ||||
| Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 44 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Italy | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00734448 | ||||
| Other Study ID Numbers ICMJE | Myo-1954 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Corrado Francesco, University of Messina | ||||
| Study Sponsor ICMJE | University of Messina | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | University of Messina | ||||
| Verification Date | February 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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