The Incretin Effect in Patients With Gestational Diabetes Mellitus

Gestational Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01307995
• Other study ID #: GDM-INK
• Status: Completed
• Phase: N/A
• First received: March 2, 2011
• Last updated: March 2, 2011
• Start date: April 2007
• Est. completion date: May 2010

Study information

• Verified date: January 2011
• Source: Medical Universtity of Lodz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Observational Model: Case-Crossover

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Locations

Country	Name	City	State
Poland	Departament of Diabetology and Metabolic Diseases, Polish Mothers Research Hospital	Lodz

Sponsors (2)

Lead Sponsor	Collaborator
Medical Universtity of Lodz	University of Copenhagen

Country where clinical trial is conducted

Poland,