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Inositol Stereoisomers to Treat Gestational Diabetes

NCT02097069 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2014-03-26

No results posted yet for this study

Summary

The investigators aim to compare the effect of different inositol stereoisomers supplementation in lowering insulin resistance levels after 8 weeks of treatment in pregnant women with GDM and in preventing adverse obstetric outcomes.

The study population includes 80 women with GDM, randomly allocated to subgroup A (folic acid 400 mcg/day), subgroup B (myo-inositol 2000 mg twice a day), subgroup C (D-chiro-inositol 250 mg twice a day), and subgroup D (Myo-inositol plus D-chiro-inositol 550mg/13,8 mg twice a day).

Folic acid or inositol stereoisomers will be administered starting at the enrolling time (24-28 week gestation, after GDM diagnosis) till the delivery.

The homeostasis model assessment of insulin resistance (HOMA-IR) and the sensitivity index (QUICKI) will be checked at the moment of the diagnostic oral glucose tolerance test (24-28 weeks) and after 8 weeks of treatment. Obstetric outcomes, the rate of women needed insulin therapy and insulin dosage will be registered.

Conditions

  • Gestational Diabetes Mellitus

Interventions

DIETARY_SUPPLEMENT

Folic acid

Folic acid 400 mcg/day

DIETARY_SUPPLEMENT

Myo-inositol

myo-inositol 2000 mg twice a day

DIETARY_SUPPLEMENT

D-Chiro-inositol

D-chiro inositol 250 mg twice a day

DIETARY_SUPPLEMENT

Myo-inositol plus D-chiro inositol

Myo-inositol plus D-chiro inositol 550mg/13,8 mg twice a day

Sponsors & Collaborators

  • Università degli Studi 'G. d'Annunzio' Chieti e Pescara

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02097069 on ClinicalTrials.gov