Gestational DiabetesIMAGENCT02133729
Metabolic Risk Following Gestational Diabetes Mellitus
A study testing Blood sampling and OGTT in people with Gestational Diabetes, run by Hospices Civils de Lyon at 7 sites in France.
Trial summary
Gestational diabetes (GDM) is defined by abnormal glucose tolerance during gestation. This complication occurs in 4-10% and is associated with fetal complications and macrosomia. In addition, women with GDM have an increased risk to develop type 2 diabetes after delivery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Blood sampling and OGTT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 7 sitesFrance
- Study dates
- Jun 2011to Apr 2015
- 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
- Women aged over 18years old
- Women with the criteria of GDM during pregnancy at 21-35 weeks of gestation (one situation):
- After a 75g Oral Glucose Tolerance Test (OGTT - WHO criteria) with blood glucose (BG) values at T60≥180mg/dl and/or T120≥153mg/dl
- An O. Sullivan test following a 100g oral glucose load with at least two pathological values (T60 ≥ 180mg/dl and/or T120 ≥ 155mg/dl and/or T180 ≥ 140mg/dl)
- With a fasting BG value ≥92mg/dl
- Women with signed informed consent
Who cannot join
- Women aged less than 18years old
- Women with pregestational type 2 diabetes
- Women without signed informed consent
- Women who does not read and/or understand french language
- Women not affiliated to the health care system
- Women with recent infection (<1month) and/or on steroids or anti-inflammatory drugs.
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- Women with chronic diseases
- Women with a disable state
- Women with normal glucose tolerance
- Women already incorporated in another clinical study that could interfere with the present study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Hospices Civils de Lyon - Hôpital Femme-Mère-Enfant - Service de gynécologie obstétrique
Bron, 69677
CHU Clermont-Ferrand - Hôpital Gabriel Montpied - Service d'endocrinologie
Clermont-Ferrand, 63003
Centre Hospitalier de Givors - Hôpital de Montgelas - Service de médicine 8
Givors, 69700
CHU Grenoble - Clinique d'Endocrinologie Diabétologie Nutrition
Grenoble, 38000
Hospices Civils de Lyon - Groupement Hospitalier Sud - Service d'Endocrinologie, Diabète, Nutrition
Pierre-Bénite, 69495
CHU Saint Etienne - Hôpital Nord - Service d'endocrinologie, diabètes, nutrition
Saint-Etienne, 42055
Groupement Hospitalier des Portes du Sud - Service d'Endocrinologie Diabétologie Nutrition
Vénissieux, 69200
About this study
Official title: IMAGE (Metabolic Risk During Gestation) : Prospective Study of Women With Gestational Diabetes
Gestational diabetes (GDM) is defined by abnormal glucose tolerance during gestation. This complication occurs in 4-10% and is associated with fetal complications and macrosomia. In addition, women with GDM have an increased risk to develop type 2 diabetes after delivery. Despite recommendations, it is difficult to follow-up all women with GDM during the postpartum period due to high numbers of subjects that exceed usual healthcare resources. It is therefore necessary to focus clinical attention toward women at high risk of type 2 diabetes in order to set adequate preventive strategies.
- Conditions
- Gestational Diabetes
- Being tested
- Blood sampling and OGTT
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling and OGTTOther
| Study group | Role | What they receive |
|---|---|---|
| Gestational diabete | Experimental | Not described Receives: Other: Blood sampling and OGTT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic index value
The primary objective relies on Receiver Operating Characteristic (ROC) curves of metabolic index values using peripheral markers during gestation : C-Reactive Protein ultrasensitive (CRPus), malonaldehyde (MDA) and adiponectin (index = (CRP + MDA)/adiponectin) to detect an abnormal glucose tolerance at 3 months (+/- 15 days) after delivery (M3) during a 75g oral glucose tolerance test (T0>110mg/dl and/or T120 >145mg/dl). The rationale for the index relies on lower adiponectin values high CRPus levels and MDA values during insulin resistance chronic inflammatory status and oxidative stress.
Measured: 3 months after delivery (+/- 15 days)
Secondary outcomes (1)
Prevalence of abnormal glucose tolerance in women with GDM
Measured: 3 months (+/- 15 days) following delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study startJun 2011
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133729
- Sponsor's protocol ID
- 2010.649
- Acronym
- IMAGE
- Status last verified
- Dec 2025
- First submitted
- 25 Apr 2014
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Honnorat D, Disse E, Millot L, Mathiotte E, Claret M, Charrie A, Drai J, Garnier L, Maurice C, Durand E, Simon C, Dupuis O, Thivolet C. Are third-trimester adipokines associated with higher metabolic risk among women with gestational diabetes? Diabetes Metab. 2015 Nov;41(5):393-400. doi: 10.1016/j.diabet.2015.03.003. Epub 2015 Apr 15.
PubMed 25890778
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMAGE (Metabolic Risk During Gestation) : Prospective Study of Women With Gestational Diabetes
- ClinicalTrials.gov ID
- NCT02133729
- Acronym / sponsor ID
- IMAGE / 2010.649
- Conditions
- Gestational Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 8 May 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.
Gestational diabetes (GDM) is defined by abnormal glucose tolerance during gestation. This complication occurs in 4-10% and is associated with fetal complications and macrosomia. In addition, women with GDM have an increased risk to develop type 2 diabetes after delivery. Despite recommendations, it is difficult to follow-up all women with GDM during the postpartum period due to high numbers of subjects that exceed usual healthcare resources. It is therefore necessary to focus clinical attention toward women at high risk of type 2 diabetes in order to set adequate preventive strategies.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gestational diabete | Experimental | Other: Blood sampling and OGTT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women aged over 18years old
- Women with the criteria of GDM during pregnancy at 21-35 weeks of gestation (one situation):
- Women with signed informed consent
Key exclusion criteria (10 listed)
- Women aged less than 18years old
- Women with pregestational type 2 diabetes
- Women without signed informed consent
- Women who does not read and/or understand french language
- Women not affiliated to the health care system
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 |
|---|---|---|
| Blood sampling and OGTT | Other | Gestational diabete |
Primary outcome
Metabolic index value
Time frame: 3 months after delivery (+/- 15 days)
The primary objective relies on Receiver Operating Characteristic (ROC) curves of metabolic index values using peripheral markers during gestation : C-Reactive Protein ultrasensitive (CRPus), malonaldehyde (MDA) and adiponectin (index = (CRP + MDA)/adiponectin) to detect an abnormal glucose tolerance at 3 months (+/- 15 days) after delivery (M3) during a 75g oral glucose tolerance test (T0>110mg/dl and/or T120 >145mg/dl). The rationale for the index relies on lower adiponectin values high CRPus levels and MDA values during insulin resistance chronic inflammatory status and oxidative stress.
1 secondary outcome
Prevalence of abnormal glucose tolerance in women with GDM
Time frame: 3 months (+/- 15 days) following delivery
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 19 Dec 2025.
- Results publication: PubMed 25890778Honnorat D, Disse E, Millot L, Mathiotte E, Claret M, Charrie A, Drai J, Garnier L, Maurice C, Durand E, Simon C, Dupuis O, Thivolet C. Are third-trimester adipokines associated with higher metabolic risk among women with gestational diabetes? Diabetes Metab. 2015 Nov;41(5):393-400. doi: 10.1016/j.diabet.2015.03.003. Epub 2015 Apr 15.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling and OGTT in people with Gestational Diabetes, run by Hospices Civils de Lyon at 7 sites 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 6 inclusion and 10 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 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Metabolic index value (time frame: 3 months after delivery (+/- 15 days)). 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 NCT02133729, which also lists 1 linked publication.
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 19 Dec 2025.