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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02770079
Recruitment Status : Recruiting
First Posted : May 12, 2016
Last Update Posted : October 15, 2018
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.


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
Diabetes, Gestational

Study Type : Observational
Estimated Enrollment : 40 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
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Gestational diabetes
20 women with gestational diabetes
20 women with no 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.

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 identifier (NCT number): NCT02770079

Contact: Gitte O Skajaa, MD +45 61772451
Contact: Ulla K Opstrup, MD, PhD +45 22370857

Aarhus University Hospital, NBG Recruiting
Aarhus, Denmark, 8000
Contact: Gitte O Skajaa, MD   
Contact: Ullla K Opstrup, MD PhD         
Sponsors and Collaborators
University of Aarhus
Principal Investigator: Per G Ovesen, MD, DMSc University of Aarhus

Responsible Party: University of Aarhus Identifier: NCT02770079     History of Changes
Other Study ID Numbers: GDM_Clamp_Skajaa
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2017

Keywords provided by University of Aarhus:
Insulin sensitivity

Additional relevant MeSH terms:
Diabetes, Gestational
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Pregnancy Complications
Diabetes Mellitus
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs