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

• Sponsor: G. d'Annunzio University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01342874
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Duration (Months): 12
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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	Phase
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

• 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: Aug 1, 2010
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	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

Primary Outcome Measures

1. Insulin therapy in early diagnosis of GDM [6 months]

   Inositol supplementation and diet with/without insulin therapy in early GDM

2. altered OGTT [6 months]

   OGTT altered at 24-28 wks in inositol and control group

Secondary Outcome Measures

1. delivery and neonatal outcomes [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

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• singleton pregnant women

• random fasting glucose above 92 mg%

Exclusion Criteria:

• BMI >30

• random fasting glucose above 126 mg%

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chieti	Chieti	CH	Italy	66100

Sponsors and Collaborators

• G. d'Annunzio University

Investigators

• Principal Investigator: Claudio Celentano, MD, ObGyn Dept

Study Documents (Full-Text)

None provided.

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
• Other Study ID Numbers: INOS001
• First Posted: Apr 27, 2011
• Last Update Posted: Feb 9, 2012
• Last Verified: Apr 1, 2011

• Keywords provided by Claudio Celentano, MD, G. d'Annunzio University: inositol; gestational diabetes mellitus; obstetric adverse outcomes
• Additional relevant MeSH terms: Diabetes, Gestational; Diabetes Mellitus; Inositol

Study Results

No Results Posted as of Feb 9, 2012