Metabolic Risk and Life Style Factors in Women With Previous Gestational Diabetes Mellitus (GDM)
Diabetes, Metabolic Risk Factors, Autoimmunity and Self-reported Life Style Factors in Women With Previous Gestational Diabetes Mellitus (GDM)
1 other identifier
observational
210
1 country
1
Brief Summary
Women with previous Gestational Diabetes Mellitus (GDM) are characterized by several metabolic abnormalities i.e. insulin resistance, beta-cell dysfunction and increased risk of later Diabetes Mellitus (DM). These latent disorders of glucose metabolism are demasked by the metabolic stress of pregnancy and as a routine, clinical assessment and measurement of HbA1c in addition to an oral glucose tolerance test (OGTT) is offered 3 months post partum. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 4, 2017
CompletedFirst Posted
Study publicly available on registry
February 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedNovember 28, 2025
November 1, 2017
6.2 years
January 4, 2017
November 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Type 2 diabetes
7 to 8 years after giving birth
Secondary Outcomes (7)
Plasma glucose (mmol/l) at 0, 30 and 120 minutes during oral glucose tolerance test
7 to 8 years after giving birth
Serum insulin (mU/l) at 0, 30 and 120 minutes during oral glucose tolerance test
7 to 8 years after giving birth
Body mass index (kg/m2)
7 to 8 years after giving birth
Blood pressure (mmHg)
7 to 8 years after giving birth
Questionnaires, quality of life (SF12), physical and mental summary scores
7 to 8 years after giving birth
- +2 more secondary outcomes
Study Arms (2)
previous GDM
Women with previous GDM
no previous GDM
Women without previous GDM matched on age, pregestational body mass index end time of pregnancy.
Eligibility Criteria
1. Women with gestational diabetes in a previous pregnancy and information from post partum ogtt. 2. A control Group of women without GDM matched on pre-pregnancy BMI, age and time of birth.
You may qualify if:
- Previous GDM with information from post partum OGTT
- Danish speaking
You may not qualify if:
- Bariatric surgery
- Poorly controlled psychiatric disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Southern Denmark
Odense, 5000, Denmark
Biospecimen
blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dorte M Jensen
University of Southern Denmark
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2017
First Posted
February 13, 2017
Study Start
June 1, 2011
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
November 28, 2025
Record last verified: 2017-11