PregnancyFRUCTONCT02159378
Fructosamines and Gestational Diabetes (FRUCTO)
A study testing Fructosamines in people with Pregnancy and Gestational Diabetes, run by Centre Hospitalier Departemental Vendee at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Gestational Diabetes
- What is being tested?
- Fructosamines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Fructosamines
- Keywords
- Gestational Diabetes, Fructosamines, Insulin treatment
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FructosaminesOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Fructosamines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum fructosamine rate
Measured: at baseline (when gestational diabetes is diagnosed: between 24 and 28 weeks of gestation or later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume DUCARME, PH, Principal investigator, Centre Hospitalier Départemental Vendée
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159378
- Sponsor's protocol ID
- CHD008-14
- Acronym
- FRUCTO
- Status last verified
- Nov 2025
- First submitted
- 6 Jun 2014
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29278829Ducarme 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.
PubMed 30578686
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fructosamines and Gestational Diabetes (FRUCTO)
- ClinicalTrials.gov ID
- NCT02159378
- Acronym / sponsor ID
- FRUCTO / CHD008-14
- Conditions
- Pregnancy, Gestational Diabetes
- Keywords
- Gestational Diabetes, Fructosamines, Insulin treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 9 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GD with Insulin treatment | Other | Other: FructosaminesAt 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. |
| GD without Insulin treatment | Other | Other: FructosaminesAt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fructosamines | Other | GD with Insulin treatment, GD without Insulin treatment |
Primary outcome
Serum fructosamine rate
Time frame: at baseline (when gestational diabetes is diagnosed: between 24 and 28 weeks of gestation or later)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Background: PubMed 29278829Ducarme 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.
- Results publication: PubMed 30578686Ducarme 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume DUCARME, PH principal investigator
Centre Hospitalier Départemental Vendée
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fructosamines in people with Pregnancy and Gestational Diabetes, run by Centre Hospitalier Departemental Vendee at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum fructosamine rate (time frame: at baseline (when gestational diabetes is diagnosed: between 24 and 28 weeks of gestation or later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02159378, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.