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

Completed

• Conditions: Diabetes, Gestational

• Registration Number: NCT02770079
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-01
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-12
• Primary Completion: 2019-07
• Status Verified: 2019-09
• Study Completion: 2019-09
• Last Update Submitted: 2019-09-25
• Last Update Posted: 2019-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Aarhus University Hospital, NBG; 🇩🇰 Aarhus, Denmark