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

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ClinicalTrials.gov Identifier: NCT02770079
Recruitment Status : Completed
First Posted : May 12, 2016
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Diabetes, Gestational

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Botnia Clamp in Women Before, Immediately After Delivery and 6 Months Post Partum.
Actual Study Start Date : May 2016
Actual Primary Completion Date : July 2019
Actual Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Group/Cohort
Gestational diabetes
10 women with gestational diabetes



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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
Whole blood approximately 10 mL.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All women visiting the outpatient gestational diabetes clinic at Aarhus University Hospital will be approached.
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Denmark
Aarhus University Hospital, NBG
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Per G Ovesen, MD, DMSc University of Aarhus
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02770079    
Other Study ID Numbers: GDM_Clamp_Skajaa
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Keywords provided by University of Aarhus:
Insulin sensitivity
Additional relevant MeSH terms:
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Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Pregnancy Complications
Diabetes Mellitus
Endocrine System Diseases