Metabolic Risk and Life Style Factors in Women With Previous Gestational Diabetes Mellitus (GDM)
NCT ID: NCT03050645
Last Updated: 2025-11-28
Study Results
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Basic Information
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COMPLETED
210 participants
OBSERVATIONAL
2011-06-30
2017-08-31
Brief Summary
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In this study, women with previous GDM and a control group matched on age, time of birth and BMI around 8 years after pregnancy will be investigated. Information from pregnancy and post partum examination (GDM only) will be used to identify risk factors for later development of DM. Further, life-style factors and mental health according to diabetes status will be studied.
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Detailed Description
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It is well established that women with previous GDM are characterized by several metabolic abnormalities i.e. insulin resistance, beta-cell dysfunction and increased risk of later Diabetes Mellitus (DM). Furthermore, GDM is a heterogeneous condition covering both women with a strong genetic disposition to type 2 DM, women in the early stages of autoimmune DM and rare cases of monogenetic DM. These latent disorders of glucose metabolism are damasked by the metabolic stress of pregnancy.
Aims
1. To study predictors of DM and pre-DM after GDM: a) At the time of pregnancy: age, blood pressure, pre-pregnancy Body Mass Index (BMI), b) 3 months post partum: indices of insulin sensitivity and beta-cell function, lipid profile, GAD-autoantibodies, HbA1c
2. To study lifestyle factors 7-8 years after GDM pregnancy in relation to current diabetes status
Materials and methods
During 2011-2017 women with previous GDM and a control group are invited to a long-term follow-up. Data collection is performed 7-8 years after pregnancy. GDM subjects (n\~150), controls (n\~50):
1. Anthropometrics: weight, height, waist circumference, blood pressure and length
2. Analyses: p-glucose, s-insulin at 0, 30 and 120 minutes during a 2-h 75 g OGTT. Fasting: total cholesterol, HDL, LDL triglycerides, GAD- autoantibodies, Hba1C, Urine albumin/creatinine ratio.
3. Questionnaires: Information on lifestyle and health status
Data available around pregnancy
Pregnancy data from hospital journals (GDM subjects and controls):
Examinations 3 months post-partum (GDM subjects only):
Clinical examination, 2-h 75 g OGTT with measurements of p-glucose and s- insulin at 0, 30 and 120 minutes, fasting total cholesterol, HDL, LDL and triglycerides, HbA1c and GAD- autoantibodies.
Perspectives
Our current population is unique as clinical, metabolic and autoimmune markers were determined prospectively a few months after GDM pregnancy and at follow-up. Hopefully, the results will enable us to target preventive actions in women with previous GDM and improve our understanding of pathophysiologic mechanisms in pre-diabetic conditions.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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previous GDM
Women with previous GDM
No interventions assigned to this group
no previous GDM
Women without previous GDM matched on age, pregestational body mass index end time of pregnancy.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Danish speaking
Exclusion Criteria
* Poorly controlled psychiatric disorder
FEMALE
Yes
Sponsors
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University of Southern Denmark
OTHER
Responsible Party
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Principal Investigators
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Dorte M Jensen
Role: PRINCIPAL_INVESTIGATOR
University of Southern Denmark
Locations
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University of Southern Denmark
Odense, , Denmark
Countries
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Other Identifiers
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University of Southern Denmark
Identifier Type: -
Identifier Source: org_study_id
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