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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
  Purpose

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 Intervention
Gestational Diabetes Mellitus
 Dietary Supplement: Inositol

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

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

Further study details as provided by G. d'Annunzio University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Enrollment: 30
Study Start Date: August 2010
Study Completion Date: August 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Inositol group
Inositol dietary exposure 4000 mg/day
 Dietary Supplement: Inositol
inositol exposure in early GDM
Control group
folic acid 400 mcg/day

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:

Responsible Party: Claudio Celentano, MD, G. d'Annunzio University
ClinicalTrials.gov Identifier: NCT01342874     History of Changes
Other Study ID Numbers: INOS001
Study First Received: April 19, 2011
Last Updated: February 8, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by 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
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013