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The Incretin Effect in Patients With Gestational Diabetes Mellitus

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. Read our disclaimer for details. Identifier: NCT01307995
Recruitment Status : Completed
First Posted : March 3, 2011
Last Update Posted : March 3, 2011
University of Copenhagen
Information provided by:
Medical Universtity of Lodz

Brief Summary:
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.

Condition or disease
Gestational Diabetes

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Crossover
Official Title: Observational Study to Evaluate the Reduced Incretin Effect Observed in Patients With GDM in Relation to Reversibility After a Delivery.
Study Start Date : April 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Patients with Gestational Diabetes Mellitus found during pregnancy by means of 75g OGTT
Pregnant patients with normal glucose tolerance as observed in 75g OGTT

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

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

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): NCT01307995

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Departament of Diabetology and Metabolic Diseases, Polish Mothers Research Hospital
Lodz, Poland, 93-338
Sponsors and Collaborators
Medical Universtity of Lodz
University of Copenhagen
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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
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Responsible Party: Marcin Kosinski, Diabetology and Metabolic Diseases Departament Identifier: NCT01307995    
Other Study ID Numbers: GDM-INK
First Posted: March 3, 2011    Key Record Dates
Last Update Posted: March 3, 2011
Last Verified: January 2011
Keywords provided by Medical Universtity of Lodz:
incretin effect
Additional relevant MeSH terms:
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Diabetes, Gestational
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases