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:

MedlinePlus related topics: Diabetes Medicines

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

Corrado F, D'Anna R, Di Vieste G, Giordano D, Pintaudi B, Santamaria A, Di Benedetto A. The effect of myoinositol supplementation on insulin resistance in patients with gestational diabetes. Diabet Med. 2011 Aug;28(8):972-5. doi: 10.1111/j.1464-5491.2011.03284.x.


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 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Pregnancy Complications Inositol	Growth Substances Micronutrients Pharmacologic Actions Physiological Effects of Drugs Vitamin B Complex Vitamins

ClinicalTrials.gov processed this record on February 27, 2015

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