Fructosamines and Gestational Diabetes (FRUCTO)

NCT02159378 | Completed

• 1 other identifier: CHD008-14
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Pregnancy; Gestational Diabetes

Keywords

Gestational Diabetes; Fructosamines; Insulin treatment

Outcome Measures

Primary Outcomes (1)

• Serum fructosamine rate

  at baseline (when gestational diabetes is diagnosed: between 24 and 28 weeks of gestation or later)

Study Arms (2)

GD with Insulin treatment

OTHER

At the end of the study patients will be divided into two groups: "GD with Insulin treatment" versus "GD without Insulin treatment" In each group, the serum fructosamines rate will be estimated with a confidence interval of 95% and compared from a Student test.

Other: Fructosamines

GD without Insulin treatment

OTHER

At the end of the study patients will be divided into two groups: "GD with Insulin treatment" versus "GD without Insulin treatment" In each group, the serum fructosamines rate will be estimated with a confidence interval of 95% and compared from a Student test.

Other: Fructosamines

Interventions

Fructosamines OTHER

GD with Insulin treatment; GD without Insulin treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (1)

Centre hospitalier départemental Vendée

La Roche-sur-Yon, 85925, France

Location

Related Publications (2)

• Ducarme G, Desroys Du Roure F, Le Thuaut A, Grange J, Dimet J, Crepin-Delcourt I. Efficacy of maternal and biological parameters at the time of diagnosis of gestational diabetes mellitus in predicting neonatal morbidity. Eur J Obstet Gynecol Reprod Biol. 2018 Feb;221:113-118. doi: 10.1016/j.ejogrb.2017.12.036. Epub 2017 Dec 19.

  PMID: 29278829 BACKGROUND

• Ducarme G, Desroys du Roure F, Grange J, Vital M, Le Thuaut A, Crespin-Delcourt I. Predictive factors of subsequent insulin requirement for glycemic control during pregnancy at diagnosis of gestational diabetes mellitus. Int J Gynaecol Obstet. 2019 Mar;144(3):265-270. doi: 10.1002/ijgo.12753. Epub 2019 Jan 11.

  PMID: 30578686 RESULT

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

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

Study Officials

• Guillaume DUCARME, PH

  Centre Hospitalier Départemental Vendée

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2014
• First Posted: June 9, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: March 1, 2016
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

FR (1)