Insulin Sensitivity and Secretion During Pregnancy and Post Partum in Women With Gestational Diabetes.
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|ClinicalTrials.gov Identifier: NCT02770079|
Recruitment Status : Recruiting
First Posted : May 12, 2016
Last Update Posted : November 1, 2017
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.
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.
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Botnia Clamp in Women Before, Immediately After Delivery and 6 Months Post Partum.|
|Actual Study Start Date :||May 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||July 2018|
20 women with gestational diabetes
20 women with no gestational diabetes.
- 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
- 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. ]Investigators will ask the participants to bring feces samples from themselves and their baby.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770079
|Contact: Gitte O Skajaa, MD||+45 firstname.lastname@example.org|
|Contact: Ulla K Opstrup, MD, PhD||+45 email@example.com|
|Aarhus University Hospital, NBG||Recruiting|
|Aarhus, Denmark, 8000|
|Contact: Gitte O Skajaa, MD firstname.lastname@example.org|
|Contact: Ullla K Opstrup, MD PhD|
|Principal Investigator:||Per G Ovesen, MD, DMSc||University of Aarhus|