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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Claudio Celentano, G. d'Annunzio University
ClinicalTrials.gov Identifier:
NCT01342874
First received: April 19, 2011
Last updated: February 8, 2012
Last verified: April 2011
History of Changes

April 19, 2011
February 8, 2012
August 2010
April 2011   (final data collection date for primary outcome measure)
  • Insulin therapy in early diagnosis of GDM [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Inositol supplementation and diet with/without insulin therapy in early GDM
  • altered OGTT [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    OGTT altered at 24-28 wks in inositol and control group
Same as current
Complete list of historical versions of study NCT01342874 on ClinicalTrials.gov Archive Site
delivery and neonatal outcomes [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
prevention of maternal and fetal adverse outcomes deriving from GDM (LGA fetuses, poly-hydramnios, C-section rate, gestational age at delivery, birthweight, birth injuries)
delivery and neonatal outcomes [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
prevention of maternal and fetal adverse outcomes deriving from GDM
Not Provided
Not Provided
 
Improved Outcomes Associated With Inositol Dietary Supplementation in Women With Gestational Diabetes Mellitus
Improved Maternal and Fetal Outcomes Associated With Inositol Dietary Supplementation in Women With Early Gestational Diabetes Mellitus

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.

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.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

pregnant women presenting random fasting glucose during the first half of pregnancy above 92 mg%
Gestational Diabetes Mellitus
Dietary Supplement: Inositol
inositol exposure in early GDM
  • Inositol group
    Inositol dietary exposure 4000 mg/day
    Intervention: Dietary Supplement: Inositol
  • Control group
    folic acid 400 mcg/day
Corrado F, D'anna R, Di Vieste G, Giordano D, Pintaudi B, Santamaria A, Di Benedetto. The effect of myoinositol supplementation on insulin resistance in patients with gestational diabetes. Diabet Med. 2011 Mar 12; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
August 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • BMI >30
  • random fasting glucose above 126 mg%
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01342874
INOS001
Yes
Claudio Celentano, G. d'Annunzio University
G. d'Annunzio University
Not Provided
Principal Investigator: Claudio Celentano, MD ObGyn Dept
G. d'Annunzio University
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP