Insulin Sensitivity and Secretion During Pregnancy and Post Partum in Women With Gestational Diabetes.

Botnia Clamp in Women Before, Immediately After Delivery and 6 Months Post Partum.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02770079

Enrollment

Registered

2016-05-12

Start date

2016-05-31

Completion date

2019-09-30

Last updated

2019-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Gestational

Keywords

Insulin sensitivity

Brief 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 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Written consent before study start. * Pregnant. * GDM for the GDM group. * No diabetes for the control group.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Change in insulin sensitivity	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

Secondary

Measure	Time frame	Description
Changes in the microbiota	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.

Countries

Denmark

Outcome results