Back to resultsMetabolic Risk Following Gestational Diabetes Mellitus (IMAGE)
Primary Purpose
Gestational Diabetes
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling and OGTT
Sponsored by
About this trial
This is an interventional screening trial for Gestational Diabetes
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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
Sites / Locations
- Hospices Civils de Lyon - Hôpital Femme-Mère-Enfant - Service de gynécologie obstétrique
- CHU Clermont-Ferrand - Hôpital Gabriel Montpied - Service d'endocrinologie
- Centre Hospitalier de Givors - Hôpital de Montgelas - Service de médicine 8
- CHU Grenoble - Clinique d'Endocrinologie Diabétologie Nutrition
- Hospices Civils de Lyon - Groupement Hospitalier Sud - Service d'Endocrinologie, Diabète, Nutrition
- CHU Saint Etienne - Hôpital Nord - Service d'endocrinologie, diabètes, nutrition
- Groupement Hospitalier des Portes du Sud - Service d'Endocrinologie Diabétologie Nutrition
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gestational diabete
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Prevalence of abnormal glucose tolerance in women with GDM
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02133729
Brief Title
Metabolic Risk Following Gestational Diabetes Mellitus
Acronym
IMAGE
Official Title
IMAGE (Metabolic Risk During Gestation) : Prospective Study of Women With Gestational Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
255 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gestational diabete
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Blood sampling and OGTT
Primary Outcome Measure Information:
Title
Metabolic index value
Description
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.
Time Frame
3 months after delivery (+/- 15 days)
Secondary Outcome Measure Information:
Title
Prevalence of abnormal glucose tolerance in women with GDM
Time Frame
3 months (+/- 15 days) following delivery
Other Pre-specified Outcome Measures:
Title
Prevalence of type 2 diabetes in women with GDM.
Description
Prevalence of women with fasting blood glucose levels > 126mg/dl at 18 months (+/- 2 months) after delivery.
Time Frame
18 months (+/- 2 months) after delivery
Title
Adiponectin level
Time Frame
18 months (+/- 2 months) after delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
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
Facility Information:
Facility Name
Hospices Civils de Lyon - Hôpital Femme-Mère-Enfant - Service de gynécologie obstétrique
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
CHU Clermont-Ferrand - Hôpital Gabriel Montpied - Service d'endocrinologie
City
Clermont-ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Centre Hospitalier de Givors - Hôpital de Montgelas - Service de médicine 8
City
Givors
ZIP/Postal Code
69700
Country
France
Facility Name
CHU Grenoble - Clinique d'Endocrinologie Diabétologie Nutrition
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
Hospices Civils de Lyon - Groupement Hospitalier Sud - Service d'Endocrinologie, Diabète, Nutrition
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
CHU Saint Etienne - Hôpital Nord - Service d'endocrinologie, diabètes, nutrition
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
Groupement Hospitalier des Portes du Sud - Service d'Endocrinologie Diabétologie Nutrition
City
Venissieux
ZIP/Postal Code
69200
Country
France
12. IPD Sharing Statement
Learn more about this trial
Metabolic Risk Following Gestational Diabetes Mellitus
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