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CompletedNCT02770079Updated Sep 27, 2019

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

An observational study in Diabetes, Gestational, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-27.

Sponsored by University of Aarhus · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
10
Ages
18 Years to 50 Years
Sex
Female
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Study 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.

02

Conditions studied

  • Diabetes, Gestational

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Keywords

  • Insulin sensitivity
03

In context

Diabetes, Gestational

842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.

This study's enrollment of 10 is below the median of 200 across 269 observational studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
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

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

Observational model
Case-control
Time perspective
Prospective
Enrollment
10 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Gestational diabetes

    10 women with gestational diabetes

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What researchers measure

Primary outcomes

  1. 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

    Time frame: Determined one time between gestational week 32 to 37, 14 days postpartum and 6 months postpartum.

Secondary outcomes

  1. Changes in the microbiota

    Investigators will ask the participants to bring feces samples from themselves and their baby.

    Time frame: Determined one time between gestational week 32 to 37 (only the mother), 14 days postpartum and 6 months postpartum.

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Study locations

1 site
  • Aarhus University Hospital, NBG
    Aarhus, 8000, Denmark
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References and documents

Publications

  • Skajaa GO, Fuglsang J, Knorr S, Moller N, Ovesen P, Kampmann U. Changes in insulin sensitivity and insulin secretion during pregnancy and post partum in women with gestational diabetes. BMJ Open Diabetes Res Care. 2020 Oct;8(2):e001728. doi: 10.1136/bmjdrc-2020-001728. PubMed 33115822 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02770079
Lead sponsor
University of Aarhus
Responsible party
Sponsor
First posted
May 12, 2016
Start date
May 2016
Primary completion
Jul 2019
Completion
Sep 2019
Last update
Sep 27, 2019

Study contacts

Per G Ovesen, MD, DMSc
principal investigator · University of Aarhus

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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