The Incretin Effect in Patients With Gestational Diabetes Mellitus

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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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Departament of Diabetology and Metabolic Diseases, Polish Mothers Research Hospital

Lodz, 93-338, Poland

Who can participate

Healthy volunteers accepted: Yes

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

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

Sponsors and collaborators

Lead sponsor

Medical University of Lodz

Other

Collaborators

University of Copenhagen

Registry information

Official study title

Observational Study to Evaluate the Reduced Incretin Effect Observed in Patients With GDM in Relation to Reversibility After a Delivery.

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2010
First posted: Mar 3, 2011
Registry last updated: Mar 3, 2011

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.

Published trials that share one or more normalized conditions with this study.

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