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

Diabetes, Gestational Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02770079
• Other study ID #: GDM_Clamp_Skajaa
• Status: Completed
• Start date: May 2016
• Est. completion date: September 2019

Study information

• Verified date: September 2019
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes, Gestational

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, NBG	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Determined one time between gestational week 32 to 37, 14 days postpartum and 6 months postpartum.
Secondary	Changes in the microbiota	Investigators will ask the participants to bring feces samples from themselves and their baby.	Determined one time between gestational week 32 to 37 (only the mother), 14 days postpartum and 6 months postpartum.