Type2 DiabetesNCT03050645
Metabolic Risk and Life Style Factors in Women With Previous Gestational Diabetes Mellitus (GDM)
An observational study of Type2 Diabetes and Gestational Diabetes, run by University of Southern Denmark at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes, Gestational Diabetes, Life Style
- How many people
- 210 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2011to Aug 2017
- Phase
- Observational
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Previous GDM with information from post partum OGTT
- Danish speaking
Who cannot join
- Bariatric surgery
- Poorly controlled psychiatric disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diabetes, Metabolic Risk Factors, Autoimmunity and Self-reported Life Style Factors in Women With Previous Gestational Diabetes Mellitus (GDM)
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.
Read the detailed description
Background
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
- 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
- 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):
- Anthropometrics: weight, height, waist circumference, blood pressure and length
- 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.
- 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
- Type2 Diabetes, Gestational Diabetes, Life Style
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| previous GDM | Women with previous GDM | |
| no previous GDM | Women without previous GDM matched on age, pregestational body mass index end time of pregnancy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type 2 diabetes
Measured: 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
Measured: 7 to 8 years after giving birth
Serum insulin (mU/l) at 0, 30 and 120 minutes during oral glucose tolerance test
Measured: 7 to 8 years after giving birth
Body mass index (kg/m2)
Measured: 7 to 8 years after giving birth
Blood pressure (mmHg)
Measured: 7 to 8 years after giving birth
Questionnaires, quality of life (SF12), physical and mental summary scores
Measured: 7 to 8 years after giving birth
Questionnaires, mental health (WHO-5), WHO-Five well being index
Measured: 7 to 8 years after giving birth
Questionnaires, physical activity (PAS 2), physical activity score
Measured: 7 to 8 years after giving birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study startJun 2011
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dorte M Jensen, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050645
- Sponsor's protocol ID
- University of Southern Denmark
- Status last verified
- Nov 2017
- First submitted
- 4 Jan 2017
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes, Metabolic Risk Factors, Autoimmunity and Self-reported Life Style Factors in Women With Previous Gestational Diabetes Mellitus (GDM)
- ClinicalTrials.gov ID
- NCT03050645
- Acronym / sponsor ID
- University of Southern Denmark
- Conditions
- Type2 Diabetes, Gestational Diabetes, Life Style
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 13 Feb 2017 (actual)
- 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.
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.
Detailed description
Background
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
- 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
- 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):
- Anthropometrics: weight, height, waist circumference, blood pressure and length
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| previous GDM | – | –Women with previous GDM |
| no previous GDM | – | –Women without previous GDM matched on age, pregestational body mass index end time of pregnancy. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Previous GDM with information from post partum OGTT
- Danish speaking
Key exclusion criteria (2 listed)
- Bariatric surgery
- Poorly controlled psychiatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Type 2 diabetes
Time frame: 7 to 8 years after giving birth
7 secondary outcomes
Plasma glucose (mmol/l) at 0, 30 and 120 minutes during oral glucose tolerance test
Time frame: 7 to 8 years after giving birth
Serum insulin (mU/l) at 0, 30 and 120 minutes during oral glucose tolerance test
Time frame: 7 to 8 years after giving birth
Body mass index (kg/m2)
Time frame: 7 to 8 years after giving birth
Blood pressure (mmHg)
Time frame: 7 to 8 years after giving birth
Questionnaires, quality of life (SF12), physical and mental summary scores
Time frame: 7 to 8 years after giving birth
Questionnaires, mental health (WHO-5), WHO-Five well being index
Time frame: 7 to 8 years after giving birth
Questionnaires, physical activity (PAS 2), physical activity score
Time frame: 7 to 8 years after giving birth
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 28 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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.
Dorte M Jensen principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type2 Diabetes and Gestational Diabetes, run by University of Southern Denmark at 1 site in Denmark.
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 2 inclusion and 2 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 28 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 Denmark. 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?
Type 2 diabetes (time frame: 7 to 8 years after giving birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2025.