Diabetes, GestationalNCT02770079
Insulin Sensitivity and Secretion During Pregnancy and Post Partum in Women With Gestational Diabetes.
An observational study of Diabetes, Gestational, run by University of Aarhus at 1 site in Denmark.
Trial summary
Aim of the study: To define insulin requirement during pregnancy and to identify the rapid changes in insulin sensitivity around parturition and the first 6 months post partum. Such knowledge would be clinically useful and markedly improve insulin treatment before and after parturition for women with type 1 diabetes… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Gestational
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- May 2016to Sep 2019
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All women visiting the outpatient gestational diabetes clinic at Aarhus University Hospital will be approached.
Who may be able to join
- Written consent before study start.
- Pregnant.
- GDM for the GDM group.
- No diabetes for the control group.
Who cannot join
- Women with multiple pregnancy.
- New pregnancy before all three examinations has been done.
- Severe, debilitating, concurrent diseases.
- Serious or intolerable adverse reactions associated with the studies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Botnia Clamp in Women Before, Immediately After Delivery and 6 Months Post Partum.
Aim of the study:
To define insulin requirement during pregnancy and to identify the rapid changes in insulin sensitivity around parturition and the first 6 months post partum. Such knowledge would be clinically useful and markedly improve insulin treatment before and after parturition for women with type 1 diabetes and serve to identify the best possible timing of testing women with gestational diabetes mellitus (GDM) for the development of type 2 diabetes post partum.
Read more
Method:
Botnia clamp in women before, immediately after delivery and 6 months post partum. The investigators will compare 20 women with GDM in late pregnancy, day 15 post partum and 6 months post partum with 20 normal women investigated at the same time points. In addition the investigators will collect feces samples from the mother and baby in order to determine microbiota.
Perspectives:
Diabetes is a common condition with important implications for pregnancy outcome and long-term morbidity for mother and offspring. Accordingly, tailoring the best treatment is expected to have beneficial consequences both for the pregnant women and the future generation.
- Conditions
- Diabetes, Gestational
- Keywords
- Insulin sensitivity
- Medical subject headings
- Diabetes, Gestational, Insulin Resistance
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 |
|---|---|---|
| Gestational diabetes | 10 women with gestational diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin sensitivity
Performing a Botnia clamp 3 times around parturition on women with GDM and comparing them with women with no GDM. The women will be their own control prospectively but also compared with a control group without gestational diabetes in order to compared them cross sectionally
Measured: Determined one time between gestational week 32 to 37, 14 days postpartum and 6 months postpartum.
Secondary outcomes (1)
Changes in the microbiota
Investigators will ask the participants to bring feces samples from themselves and their baby.
Measured: Determined one time between gestational week 32 to 37 (only the mother), 14 days postpartum and 6 months postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2019
- Study completionSep 2019
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 Diabetes, GestationalStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Per G Ovesen, MD, DMSc, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770079
- Sponsor's protocol ID
- GDM_Clamp_Skajaa
- Status last verified
- Sep 2019
- First submitted
- 1 May 2016
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Skajaa GO, Fuglsang J, Knorr S, Moller N, Ovesen P, Kampmann U. Changes in insulin sensitivity and insulin secretion during pregnancy and post partum in women with gestational diabetes. BMJ Open Diabetes Res Care. 2020 Oct;8(2):e001728. doi: 10.1136/bmjdrc-2020-001728.
PubMed 33115822
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botnia Clamp in Women Before, Immediately After Delivery and 6 Months Post Partum.
- ClinicalTrials.gov ID
- NCT02770079
- Acronym / sponsor ID
- GDM_Clamp_Skajaa
- Conditions
- Diabetes, Gestational
- Keywords
- Insulin sensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 12 May 2016 (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.
Aim of the study:
To define insulin requirement during pregnancy and to identify the rapid changes in insulin sensitivity around parturition and the first 6 months post partum. Such knowledge would be clinically useful and markedly improve insulin treatment before and after parturition for women with type 1 diabetes and serve to identify the best possible timing of testing women with gestational diabetes mellitus (GDM) for the development of type 2 diabetes post partum.
Method:
Botnia clamp in women before, immediately after delivery and 6 months post partum. The investigators will compare 20 women with GDM in late pregnancy, day 15 post partum and 6 months post partum with 20 normal women investigated at the same time points. In addition the investigators will collect feces samples from the mother and baby in order to determine microbiota.
Perspectives:
Diabetes is a common condition with important implications for pregnancy outcome and long-term morbidity for mother and offspring. Accordingly, tailoring the best treatment is expected to have beneficial consequences both for the pregnant women and the future generation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gestational diabetes | – | –10 women with gestational diabetes |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All women visiting the outpatient gestational diabetes clinic at Aarhus University Hospital will be approached.
Key inclusion criteria (4 listed)
- Written consent before study start.
- Pregnant.
- GDM for the GDM group.
- No diabetes for the control group.
Key exclusion criteria (4 listed)
- Women with multiple pregnancy.
- New pregnancy before all three examinations has been done.
- Severe, debilitating, concurrent diseases.
- Serious or intolerable adverse reactions associated with the studies.
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
Change in insulin sensitivity
Time frame: Determined one time between gestational week 32 to 37, 14 days postpartum and 6 months postpartum.
Performing a Botnia clamp 3 times around parturition on women with GDM and comparing them with women with no GDM. The women will be their own control prospectively but also compared with a control group without gestational diabetes in order to compared them cross sectionally
1 secondary outcome
Changes in the microbiota
Time frame: Determined one time between gestational week 32 to 37 (only the mother), 14 days postpartum and 6 months postpartum.
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 27 Sep 2019.
- Derived from this study: PubMed 33115822Skajaa GO, Fuglsang J, Knorr S, Moller N, Ovesen P, Kampmann U. Changes in insulin sensitivity and insulin secretion during pregnancy and post partum in women with gestational diabetes. BMJ Open Diabetes Res Care. 2020 Oct;8(2):e001728. doi: 10.1136/bmjdrc-2020-001728.
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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.
Per G Ovesen, MD, DMSc principal investigator
University of Aarhus
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 Diabetes, Gestational, run by University of Aarhus 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 4 inclusion and 4 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 27 Sep 2019. 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?
Change in insulin sensitivity (time frame: Determined one time between gestational week 32 to 37, 14 days postpartum and 6 months postpartum.). 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 NCT02770079, 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 27 Sep 2019.