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Completed

NCT Number: NCT02770079

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

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.

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Key information

Conditions

Diabetes, Gestational Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Aarhus University Hospital, NBG

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 12, 2016
Registry last updated
Sep 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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