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OpenTrials
Completed

NCT Number: NCT01342874

Improved Outcomes Associated With Inositol Dietary Supplementation in Women With 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.

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Key information

Conditions

Gestational Diabetes Mellitus Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Chieti

Chieti, CH, 66100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • BMI >30
  • random fasting glucose above 126 mg%

Treatment and study plan

inositol

Dietary Supplement

inositol exposure in early GDM

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

G. d'Annunzio University

Other

Registry information

Official study title

Improved Maternal and Fetal Outcomes Associated With Inositol Dietary Supplementation in Women With Early Gestational Diabetes Mellitus

Acronym: inositol

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 27, 2011
Registry last updated
Feb 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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