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Fructosamines and Gestational Diabetes (FRUCTO)

Fructosamines and Gestational Diabetes (FRUCTO)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02159378
Acronym
FRUCTO
Enrollment
200
Registered
2014-06-09
Start date
2014-07-31
Completion date
2016-03-31
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes, Pregnancy

Keywords

Gestational Diabetes, Fructosamines, Insulin treatment

Brief summary

The prevalence of gestational diabetes is estimated at between 2 and 6%, but can be much higher in specific populations. The specific treatment of gestational diabetes (diet, control weight gain, self monitoring glucose , insulin therapy) reduces complications severe perinatal, fetal macrosomia, and preeclampsia compared with abstention therapy, without additional risk of caesarean section. Several early studies have shown that the determination of fructosamine is a very bad way of diagnosis for Gestational Diabetes. However, few studies have investigated the relationship between the determination of serum fructosamine and put under insulin in case of Gestational Diabetes. The purpose of this study is to determine if serum fructosamines rate can be a predictive marker of the starting insulin at the patients suffering from Gestational Diabetes

Interventions

OTHERFructosamines

Sponsors

Centre Hospitalier Departemental Vendee
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥18 years * Ongoing pregnancy with a start date of pregnancy known and confirmed by an ultrasound of the 1st Quarter performed between 10 and 14 weeks with measurement of the crown-rump length * Hospitalization for a GD's discovery whatever the term of pregnancy (GD is defined with nationals recommendations of CNGOF) * Not opposed to participate in the study

Exclusion criteria

* Pregnancy uncertain term (absence of early ultrasound) * Previous diabetes to the pregnancy (type 1 or 2) * Multiple Pregnancy * No affiliation to a social security scheme * Woman with a measure of legal protection

Design outcomes

Primary

MeasureTime frame
Serum fructosamine rateat baseline (when gestational diabetes is diagnosed: between 24 and 28 weeks of gestation or later)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026