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Improved Outcomes Associated With Inositol Dietary Supplementation in Women With Gestational Diabetes Mellitus (inositol)

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ClinicalTrials.gov Identifier: NCT01342874
Recruitment Status : Completed
First Posted : April 27, 2011
Last Update Posted : February 9, 2012
Sponsor:
Information provided by (Responsible Party):
Claudio Celentano, G. d'Annunzio University

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Objective: Insulin resistance during normal pregnancy and in gestational diabetes mellitus (GDM) are unknown. New criteria are based on fasting glucose levels since the beginning of pregnancy. Inositol, a putative second messenger of insulin, correlates with the degree of insulin resistance. Dietary supplementation of inositol improves insulin resistance in patients with GDM.

Condition or disease Intervention/treatment
Gestational Diabetes Mellitus Dietary Supplement: Inositol

Detailed Description:
Methods: A randomized double-blind study was carried out in women with GDM. Patients were randomly exposed to inositol and placebo. Increase of BMI, blood glucose at 75 grams oral glucose tolerance test (OGTT), fetal and neonatal adverse outcome, and insulin treatment were correlated to inositol exposure.

Study Design
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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Improved Maternal and Fetal Outcomes Associated With Inositol Dietary Supplementation in Women With Early Gestational Diabetes Mellitus
Study Start Date : August 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Inositol
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Inositol group
Inositol dietary exposure 4000 mg/day
 Dietary Supplement: Inositol
inositol exposure in early GDM
Control group
folic acid 400 mcg/day


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Insulin therapy in early diagnosis of GDM [ Time Frame: 6 months ]
    Inositol supplementation and diet with/without insulin therapy in early GDM

  2. altered OGTT [ Time Frame: 6 months ]
    OGTT altered at 24-28 wks in inositol and control group


Secondary Outcome Measures :
  1. delivery and neonatal outcomes [ Time Frame: 6 months ]
    prevention of maternal and fetal adverse outcomes deriving from GDM (LGA fetuses, poly-hydramnios, C-section rate, gestational age at delivery, birthweight, birth injuries)


Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
pregnant women presenting random fasting glucose during the first half of pregnancy above 92 mg%
Criteria

Inclusion Criteria:

  • singleton pregnant women
  • random fasting glucose above 92 mg%

Exclusion Criteria:

  • BMI >30
  • random fasting glucose above 126 mg%
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01342874


Locations
Italy
University of Chieti
Chieti, CH, Italy, 66100
Sponsors and Collaborators
G. d'Annunzio University
Investigators
Principal Investigator: Claudio Celentano, MD ObGyn Dept
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: Claudio Celentano, MD, G. d'Annunzio University
ClinicalTrials.gov Identifier: NCT01342874     History of Changes
Other Study ID Numbers: INOS001
First Posted: April 27, 2011    Key Record Dates
Last Update Posted: February 9, 2012
Last Verified: April 2011

Keywords provided by Claudio Celentano, G. d'Annunzio University:
inositol
gestational diabetes mellitus
obstetric adverse outcomes

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