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The Incretin Effect in Patients With Gestational Diabetes Mellitus

This study has been completed.
Sponsor:
Collaborator:
University of Copenhagen
Information provided by:
Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT01307995
First received: March 2, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted

March 2, 2011
March 2, 2011
April 2007
December 2009   (final data collection date for primary outcome measure)
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No Changes Posted
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The Incretin Effect in Patients With Gestational Diabetes Mellitus
Observational Study to Evaluate the Reduced Incretin Effect Observed in Patients With GDM in Relation to Reversibility After a Delivery.

The aim of this study is to evaluate the reduced incretin effect observed in patients with T2DM in relation to reversibility. The incretin effect will be measured by means of OGTT and iIVGTT in 12 women with GDM during pregnancy (third trimester), and again 2-3 months post partum. It is anticipated that the incretin effect in patients with GDM is reduced - like in patients with other forms of DM. The investigators estimate that approximately 90 % of the patients with GDM re-establish a NGT 2-3 months post partum. This particular group of patients provides a unique possibility for demonstrating the reversibility of the reduced incretin effect in relation to optimal glycaemic control.

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Observational
Observational Model: Case-Crossover
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Probability Sample

Pregnant women above the age of 18 years with GDM) (Controls: pregnant women above the age of 18 years with NGT)

Gestational Diabetes
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  • GDM
    Patients with Gestational Diabetes Mellitus found during pregnancy by means of 75g OGTT
  • NGT
    Pregnant patients with normal glucose tolerance as observed in 75g OGTT
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
May 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age above 18 years old
  • GDM diagnosed according to WHO guidelines (GDM group) or ruled out by OGTT 75g (Control group)

Exclusion Criteria:

  • Previous diagnosis of DM
  • Positive GAD-65-autoantibodies and/or positive islet cell autoantibodies (ICA)
  • Affected biochemical liver parameters (ALAT > 2 times normal upper range)
  • Affected biochemical kidney parameters (se-creatinine > 130 µM)
  • Treatment with medicine interacting with insulin secretion (e.g. steroids)
  • Treatment with medicine that can not be paused for 16 hours
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT01307995
GDM-INK
No
Marcin Kosinski, Diabetology and Metabolic Diseases Departament
Medical Universtity of Lodz
University of Copenhagen
Study Director: Katarzyna Cypryk, MD, PhD, Asoc. Prof. Medical University Lodz
Study Director: Tina Vilsbøll, MD, DMSc University of Copenhagen
Principal Investigator: Marcin Kosiński, MD, PhD Medical University Lodz
Medical Universtity of Lodz
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP